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Publication numberUS20050085832 A1
Publication typeApplication
Application numberUS 10/919,792
Publication dateApr 21, 2005
Filing dateAug 17, 2004
Priority dateAug 27, 1998
Also published asUS6786913
Publication number10919792, 919792, US 2005/0085832 A1, US 2005/085832 A1, US 20050085832 A1, US 20050085832A1, US 2005085832 A1, US 2005085832A1, US-A1-20050085832, US-A1-2005085832, US2005/0085832A1, US2005/085832A1, US20050085832 A1, US20050085832A1, US2005085832 A1, US2005085832A1
InventorsGregory Sancoff, Douglas Fogg, Frederic Field
Original AssigneeDvl Acquisitions, Sub, Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Surgical suturing instrument and method of use
US 20050085832 A1
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.
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Claims(1)
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.
Description
    REFERENCE TO EARLIER APPLICATIONS
  • [0001]
    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
  • [0002]
    This invention relates to medical instruments and procedures in general, and more particularly to suturing instruments and methods for suturing.
  • BACKGROUND OF THE INVENTION
  • [0003]
    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).
  • [0004]
    Certain suturing instruments employ a needle that precedes a length of suture material through a subject.
  • [0005]
    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.
  • [0006]
    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.
  • [0007]
    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.
  • [0008]
    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.
  • [0009]
    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.
  • [0010]
    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.
  • [0011]
    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.
  • [0012]
    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.
  • [0013]
    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
  • [0014]
    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.
  • [0015]
    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
  • [0016]
    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:
  • [0017]
    FIG. 1 is a side view of a suturing instrument formed in accordance with the present invention;
  • [0018]
    FIG. 2 is a partial side view, partially in section, of the suturing instrument shown in FIG. 1;
  • [0019]
    FIG. 3 is a partial top view, partially in section, of the suturing instrument shown in FIG. 1;
  • [0020]
    FIG. 4 is a schematic partial side view showing some of the internal components of the suturing instrument shown in FIG. 1;
  • [0021]
    FIG. 4A is a perspective view of a drive barrel assembly incorporated in the suturing instrument shown in FIG. 1;
  • [0022]
    FIG. 5 is a perspective view of a wire guide support unit incorporated in the suturing instrument shown in FIG. 1;
  • [0023]
    FIG. 6 is a perspective view of the suturing instrument's wire supply cartridge, which includes the wire guide support unit shown in FIG. 5;
  • [0024]
    FIG. 7 is a perspective view, partially in section, of the wire supply cartridge shown in FIG. 6;
  • [0025]
    FIG. 8 is a perspective rear view of the drive barrel assembly incorporated in the suturing instrument shown in FIG. 1, with the drive barrel assembly's release lever being shown in its closed position;
  • [0026]
    FIG. 9 is a perspective view of the proximal (i.e., rear) end of the drive barrel assembly shown in FIG. 8, with the release lever being shown in its open position;
  • [0027]
    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);
  • [0028]
    FIG. 11 is a schematic view taken along the line 11-11 of FIG. 4;
  • [0029]
    FIG. 12 is a side view of a shaft and an end effector portion of the suturing instrument shown in FIG. 1;
  • [0030]
    FIG. 13 is a side view of the end effector portion of the suturing instrument shown in FIG. 1;
  • [0031]
    FIG. 14 is a side view, partially in section, of the end effector portion shown in FIG. 13, with the end effector portion being shown with its cutting bar in its forward (i.e., non-cutting) position;
  • [0032]
    FIG. 15 is a side view, partially in section, of the end effector portion shown in FIG. 14, but with the end effector portion being shown with its cutting bar in its retracted (i.e., cutting) position;
  • [0033]
    FIG. 16 is a perspective view of the end effector portion of the suturing instrument shown in FIG. 1;
  • [0034]
    FIGS. 17A-17J show various steps in a suturing operation conducted with the suturing instrument shown in FIG. 1;
  • [0035]
    FIG. 18 is a sectional view showing one possible construction for the suturing instrument's fixed jaw portion and its associated cutting bar;
  • [0036]
    FIG. 19 is a side view showing a piece of wire cut with the apparatus shown in FIG. 18;
  • [0037]
    FIG. 20 is a sectional view showing another possible fixed construction for the suturing instrument's fixed jaw portion and its associated cutting bar;
  • [0038]
    FIG. 21 is a side view showing a piece of wire cut with the apparatus shown in FIG. 20;
  • [0039]
    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;
  • [0040]
    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;
  • [0041]
    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;
  • [0042]
    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;
  • [0043]
    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
  • [0044]
    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.
  • [0045]
    FIGS. 26A-45F show additional constructions of the present invention.
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Overview
  • [0046]
    Looking first at FIG. 1, there is shown a suturing instrument 10 which comprises a preferred embodiment of the present invention. Suturing instrument 10 includes a housing 12, a handle 14, a shaft 16 and an end effector 18. Suturing instrument 10 includes a housing 12, a handle 14, a shaft 16 and an end effector 18. Suturing instrument 10 also includes a wire advance button 20, a jaw closing actuator 22, a wire cutting actuator 24, a left-thumb-actuated rotation button 26, and a right-thumb actuated rotation button 28 (FIG. 3). Suturing instrument 10 also includes a wire supply cartridge 30, as well as a shaft retaining nut 32. Shaft retaining nut 32 allows shaft 16 to be dismounted from the remainder of the device for cleaning purposes.
  • [0047]
    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 in wire supply cartridge 30 and is pushed through housing 12 and shaft 16 to end effector 18, which includes a pair of opposing jaw portions. The jaw portions may be brought together around the material which is to be sutured by actuating jaw closing actuator 22 when the jaw portions are positioned at an appropriate surgical location. The suture wire is driven through housing 12 and shaft 16 to end effector 18 by actuating wire advance button 20. 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. Shaft 16 and end effector 18 (together with wire supply cartridge 30) may then be rotated with respect to housing 12 and handle 14 by actuating either left-thumb-actuated rotation button 26 or right-thumb-actuated rotation button 28. 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, at end effector 18, from the remaining portion of the suture wire that extends back through the suturing instrument. Such cutting may be effected by actuating wire cutting actuator 24.
  • [0048]
    As will be discussed in further detail below, wire supply cartridge 30 may be supplied separately from suturing instrument 10, with the wire supply cartridge 30 being loaded into suturing instrument 10 prior to commencing a suturing operation. As will also be discussed in further detail below, wire supply cartridge 30 may be disposable, such that the cartridge may be discarded after all of its wire has been used up.
  • Construction Details
  • [0049]
    As shown in FIGS. 2 and 4, handle 14 provides a cavity that may receive batteries 34. In other embodiments, the unit may be powered remotely via a power transmission cord or any other source of suitable power.
  • [0050]
    Batteries 34 supply a ground (or negative) potential to a ground connector post 36 (FIG. 2), which in turn communicates with a rotary ground communicator 38. Rotary ground communicator 38 permits electrical contact to be maintained with ground connector post 36 when rotary ground communicator 38 is rotated with respect to ground connector post 36, as occurs when shaft 16 and end effector 18 are rotated so as to twist closed suture wire extending through the tissue.
  • [0051]
    Batteries 34 supply a positive potential to wire advance button 20, and to a first connector post 40, which in turn communicates with a first rotary electrical communicator 42. First rotary electrical communicator 42 permits electrical contact to be maintained with first connector post 40 when first rotary electrical communicator 42 is rotated with respect to first connector post 40. The positive potential from batteries 34 is also supplied (in parallel) to each thumb-activated rotation button 26, 28 (FIG. 3), and to a second connector post 44 (FIG. 2), which in turn communicates with a second rotary electrical communicator 46. Again, second rotary electrical communicator 46 permits electrical contact to be maintained with second connector post 44 when second rotary electrical communicator 46 is rotated with respect to second connector post 44. Each of the connector posts 36, 40 and 44 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. Handle 14 also includes a cap 48 which may be removed so as to permit insertion of batteries 34.
  • [0052]
    First rotary electrical communicator 42 is in electrical communication with a wire advance motor 50 shown in FIGS. 2 and 4. The output shaft of wire advance motor 50 is coupled to a miter drive gear 52, which is in turn coupled to a miter follower gear 54. Miter follower gear 54 is coupled to a drive wheel 56 which contacts the suture wire 58, as will be described in further detail below with reference to FIGS. 5-10.
  • [0053]
    Second rotary electrical communicator 46 is in electrical communication with a shaft rotation motor 60 (FIGS. 3 and 4), the output of which is coupled to a pinion gear 62 (FIGS. 4, 4A and 11) that rotates along an internal gear 64 (FIGS. 4 and 11). As shown in FIG. 3, left-thumb-actuated rotation button 26 and right-thumb-activated rotation button 28 may be provided to permit the user to use the thumb of either their left hand or their right hand, respectively, so as to actuate shaft rotation motor 60. In this respect it will be appreciated that, inasmuch as left-thumb-actuated rotation button 26 and right-thumb-actuated rotation button 28 are wired in parallel, shaft rotation motor 60 will rotate in the same direction regardless of which button (i.e., button 26 or button 28) may be actuated.
  • [0054]
    Jaw closing actuator 22 (FIGS. 2 and 4) is coupled to a jaw linkage coupler 66, which in turn contacts a jaw linkage 68 (FIGS. 2 and 14). When jaw closing actuator 22 is pulled toward handle 14 (FIG. 2), jaw closing actuator 22 pivots on its pivot pin 67 (FIG. 4) so as to drive jaw linkage coupler 66 distally, against the force of biasing spring 69, and so as to cause the jaw linkage 68 to move forward toward the distal end of suturing instrument 10. This action will in turn cause movable jaw portion 98 to close on fixed jaw portion 96 (FIG. 17A), as will hereinafter be discussed in further detail. When jaw closing actuator 22 is subsequently released, biasing spring 69 (FIG. 4) drives jaw linkage coupler 66 proximally, so as to cause jaw linkage 68 to move proximally. This action will cause movable jaw portion 98 to open relative to fixed jaw portion 96 (FIG. 14), as will hereinafter be discussed in further detail. The action of jaw linkage 68 at the distal end of the device is discussed further below with reference to FIGS. 13 and 14.
  • [0055]
    Wire cutting actuator 24 is coupled to a wire cutting linkage coupler 70 (FIGS. 2 and 4), which in turn contacts a wire cutting linkage 72 (FIGS. 2, 14 and 15). When wire cutting actuator 24 is pulled toward handle 14 (FIG. 2), wire cutting actuator 24 pivots on its pivot pin 73 (FIG. 4) so as to drive wire cutting linkage coupler 70 proximally, against the force of biasing spring 69, and so as to cause wire cutting linkage 72 to move proximally, away from the distal end of suturing instrument 10. This action will in turn cause cutting bar 104 (FIG. 14) to move proximally (FIG. 15) so as to effect wire cutting, as will hereinafter be discussed in further detail. When wire cutting actuator 24 is subsequently released, biasing spring 69 drives wire cutting linkage coupler 70 distally, so as to cause wire cutting linkage 72 to move distally. This action causes cutting bar 104 to move distally, so as to assume the position shown in FIG. 14. Wire cutting linkage 72 moves adjacent to, and independent of, jaw linkage 68 discussed above. The action of wire cutting linkage 72 at the distal end of the device is discussed further below with reference to FIGS. 14 and 15.
  • [0056]
    The wire supply cartridge 30 shown in FIG. 1 includes a wire guide support unit 74, as shown in FIGS. 5-7. A supply coil of suture wire 58 (comprising wire formed of metal or any other suitable material having the required flexibility and stiffness) may be supplied in the base of cartridge 30 and is fed into the support unit 74 as shown in FIG. 7. A wire guide 76 surrounds suture wire 58, from support unit 74 to the distal end of suturing instrument 10, adjacent to end effector 18 (FIGS. 5-7, 14 and 15). Wire guide 76 ensures that suture wire 58 does not bend or buckle as the suture wire is pushed through housing 12 and shaft 16. More particularly, wire guide 76 preferably forms a sufficiently close sliding fit with suture wire 58 such that suture wire 58 cannot bend or buckle as the suture wire is advanced through suturing instrument 10. At the same time, wire guide 76 is also formed so as to present a minimum of friction to suture wire 58 as the suture wire is advanced through the instrument. The foregoing characteristics are important, inasmuch as suture wire 58 is extremely thin and flexible and highly susceptible to bending or buckling in the absence of some sort of lateral support.
  • [0057]
    By way of example but not limitation, where suture wire 58 is formed out of stainless steel and has a diameter of 0.005 inch, wire guide 76 might have an inside diameter of 0.008 inch and an outside diameter of 0.016 inch. In addition, wire guide 76 is preferably formed out of polytetrafluoroethylene (PTFE) or some other relatively lubricious material. Alternatively, the interior of wire guide 76 may be coated with a lubricant so as to facilitate closely-supported, low-friction passage of the suture wire through the wire guide.
  • [0058]
    Further by way of example but not limitation, in one preferred form of the invention, suture wire 58 may comprise 316 LVM stainless steel having a tensile strength of 170 kpsi.
  • [0059]
    Although wire guide 76 extends through support unit 74 (FIG. 7), wire guide 76 has two openings 78 (one on either side of wire guide 76, only one of which is shown in FIG. 5) in the center of support unit 74. Openings 78 expose a portion of suture wire 58 so that wire drive wheel 56 (FIG. 8) may contact suture wire 58 and urge the suture wire forward toward the distal end of suturing instrument 10, as will be discussed in detail below with reference to FIGS. 8-10.
  • [0060]
    As shown in FIGS. 2, 3, 4A and 8, housing 12 receives a drive barrel assembly 80 that contains the aforementioned motors 50 and 60, and provides a distally-extending barrel shaft 81 (FIGS. 4A and 8), on the outside of which are located the rotary communicators 38, 42 and 46′. A recess 82 (FIG. 4A) is provided on the distal end of barrel shaft 81 for receiving a coupling pin 84 (FIGS. 2 and 4) which is located on the proximal end of shaft 16, such that rotation of drive barrel assembly 80 causes rotation of coupling pin 84 and hence shaft 16. Drive barrel assembly 80 is rotationally held within housing 12 by bearings 86, as shown in FIGS. 2 and 3.
  • [0061]
    Looking next at FIGS. 7-10, wire supply cartridge 30 may be attached to drive barrel assembly 80 by rotating a release lever 87 away from the center of drive barrel assembly 80 (FIGS. 8 and 9), so as to move a carriage 88 relative to drive barrel assembly 80. Most particularly, release lever 87 rides on a pin 90, and rotation of release lever 87 from the position shown in FIG. 8 to the position shown in FIG. 9 draws carriage 88, as well as a wire follower wheel 92, away from the center of drive barrel assembly 80. Once wire follower wheel 92 is separated from wire drive wheel 56 by a sufficient distance to expose the drive barrel assembly's central passageway 93 (FIG. 9), wire guide 76 (overlying suture wire 58) may be inserted into passageway 93 (FIG. 10), and wire guide support unit 74 (FIGS. 6, 7 and 10) may be inserted between wheels 56 and 92 (FIG. 10), such that wheels 56 and 92 contact either side of suture wire 58 through openings 78 formed in either side of wire guide 76. A biasing spring 94 (FIGS. 8-10) is provided on carriage 88 to urge wire follower wheel 92 into close contact with suture wire 58. In other embodiments, wire follower wheel 92 may also be driven indirectly by wire drive wheel 56 in order to provide additional forces to move suture wire 58 distally (i.e., forward, toward the tool's end effector 18).
  • [0062]
    Pinion gear 62 (FIGS. 4, 4A and 0.11) extends distally from drive barrel assembly 80 and engages the housing's internal gear 64, as shown in FIGS. 4 and 11. As a result of this construction, when shaft rotation motor 60 is actuated, pinion gear 62 rotates around internal gear 64, bringing with it the entire drive barrel assembly 80. This in turn causes shaft 16 to rotate, since shaft 16 is coupled to drive barrel assembly 80. More particularly, the rotation of drive barrel assembly 80 is transferred to shaft 16 through the shaft's coupling pin 84 (FIGS. 2, 4 and 12), which is seated in recess 82 (FIG. 8) of drive barrel assembly 80.
  • [0063]
    End effector 18 (FIGS. 1 and 13-16) includes a fixed jaw portion 96 and a movable jaw portion 98. Movable jaw portion 98 is coupled to the aforementioned jaw linkage 68 (FIG. 14) via a jaw linkage pin 100, such that when jaw linkage 68 is moved distally (i.e., by pulling jaw closing actuator 22 toward handle 14), jaw portion 98 is rotated about a pivot pin 102 (FIG. 13) and closes onto fixed jaw portion 96. Conversely, when jaw linkage 68 is moved proximally (i.e., by the power of biasing spring 69 acting on jaw linkage coupler 66 and hence jaw linkage 68), movable jaw portion 98 will open away from fixed jaw portion 96. It will be appreciated that the force of biasing spring 69 will normally keep movable jaw portion 98 open relative fixed jaw portion 98 (FIGS. 1, 13 and 14), unless and until jaw closing actuator 22 is activated so as to overcome the bias of spring 69.
  • [0064]
    Wire cutting linkage 72 (FIGS. 2, 3, 14 and 15) is coupled to a cutting bar 104 (FIGS. 14 and 15) that includes a small opening 106 through which suture wire 58 may pass, as will hereinafter be discussed in further detail. Preferably cutting bar 104 is slidably received in a passageway 107 (FIGS. 14, 15, 16 and 17H) formed in fixed jaw portion 96. In one position (FIG. 14), cutting bar 104 is positioned in fixed jaw portion 96 such that the cutting bar's opening 106 is aligned with a channel 108 formed in fixed jaw portion 96, whereby suture wire may be passed from the distal end of wire guide 76, through channel 108 formed in fixed jaw portion 96 (where it undergoes an approximately 90 degree change of direction), through opening 106 in cutting bar 104, through a channel extension 108A formed in fixed jaw portion 96, and across to movable jaw portion 98, as will hereinafter be discussed in further detail. However, when wire cutting linkage 72 is moved proximally by pulling wire cutting actuator 24 toward handle 14, cutting bar 104 is also moved proximally (FIG. 15) so as to cut any suture wire extending from channel 108 (in fixed portion 96) into opening 106 (in cutting bar 104). In this respect it will be appreciated that it is desirable to form channel extension 108A with a length greater than channel 108 (see FIGS. 14 and 15) so as to prevent the suture wire from being cut in two places (i.e., at channel 108 and again at channel extension 108A) when cutting bar 104 is moved proximally by pulling on wire cutting actuator 24. At the same time, however, it should also be appreciated that the fixed jaw portion's channel 108 and channel extension 108A, and the cutting bar's opening 106, are all sized, relative to suture wire 58, so as to provide as much support as possible to the suture wire as it passes through, and out of, fixed jaw portion 96.
  • [0065]
    It will be appreciated that the force of biasing spring 69 will normally keep cutting bar 104 in its distal position (i.e., with the cutting bar's opening 106 aligned with the fixed jaw portion's channel 108), unless and until wire cutting actuator 24 is activated so as to overcome the bias of spring 69.
  • [0066]
    In view of the foregoing construction, it will be seen that: (1) release lever 87 (FIGS. 8-10) may be activated so as to move wire follower wheel 92 away from, and toward, wire drive wheel 56 so as to permit a full wire supply cartridge 30 (FIGS. 1 and 5-7) to be loaded into suturing instrument 10; (2) activating jaw closing actuator 22 will cause movable jaw portion 98 to close on fixed jaw portion 96; (3) activating wire advance button 20 will cause wire drive wheel 56 to advance suture wire 58 through housing 12 and shaft 16; (4) activating rotation button 26 and/or rotation button 28 will cause shaft 16 to rotate relative to housing 12; and (5) activating wire cutting actuator 24 will cause cutting bar 104 to move proximally so as to sever any suture wire extending from fixed jaw portion 96.
  • Operation
  • [0067]
    Suturing instrument 10 may be used to apply wire suture 58 to a subject so as to effect a desired suturing operation.
  • [0068]
    By way of example but not limitation, and looking now at FIGS. 17A-17J, suturing instrument 10 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.
  • [0069]
    In any case, suturing instrument 10 is initially prepared for use by installing batteries 34 into handle 14, if batteries 34 are not already installed, and by installing wire supply cartridge 30 into the suturing instrument, if a cartridge 30 is not yet installed. As noted above, wire supply cartridge 30 is installed in suturing instrument 10 by (1) moving the drive barrel assembly's release lever 87 to its open position (FIG. 9), so as to move wire follower wheel 92 away from wire drive wheel 56 and thereby expose the barrel assembly's central passageway 93; (2) passing the distal end of the cartridge (i.e., the distal end of wire guide 76) through drive barrel assembly 80 and shaft 16 until the distal end of wire guide 76 is in communication with the channel 108 formed in fixed jaw portion 96 (FIG. 14), at which point the cartridge's wire guide support unit 74 will be positioned intermediate wire drive wheel 56 and wire follower wheel 92 (FIG. 2); and (3) moving the drive barrel assembly's release lever 87 back to its closed position (FIG. 8), so as to cause wire drive wheel 56 and wire follower wheel 92 to extend through the wire guide's openings 78 and engage suture wire 58.
  • [0070]
    At this point suturing instrument 10 will be ready for use, with its movable jaw portion 98 being opened away from its fixed jaw portion 96, and with its cutting bar 104 being in its forward (FIG. 14) position.
  • [0071]
    Next, suturing instrument 10 has its movable jaw portion 98 moved into engagement with its fixed jaw portion 96 (i.e., the jaws 96, 98 are placed in their “closed” position) by pulling jaw closing actuator 22 toward handle 14, and then the distal end of suturing instrument 10 is moved adjacent to subject portions 110, 112 (FIG. 17A).
  • [0072]
    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.
  • [0073]
    In any case, once the distal end of suturing instrument 10 has been placed adjacent to subject portions 110, 112, jaw closing actuator 22 is released, such that biasing spring 69 (FIG. 4) will cause movable jaw portion 98 to open away from fixed jaw portion 96 (FIG. 17B). Then the distal end of suturing instrument 10 is moved so that its jaws 96, 98 straddle subject portions 110, 112, and then jaw closing actuator 22 is actuated again, by pulling jaw closing actuator 22 toward handle 14, so as to close movable jaw portion 98 against fixed jaw portion 96, whereby to capture subject portions 110, 112 (FIG. 17C).
  • [0074]
    Next, wire advance button 20 is activated so as to cause suture wire 58 to be driven forward, out of the distal end of wire guide 76, through the fixed jaw portion's channel 108, through opening 106 in cutting bar 104, through the fixed jaw portion's channel extension 108A, through subject portions 110, 112, and finally through an opening 113 (FIGS. 14, 15 and 17C) formed in movable jaw portion 98. Suture wire 58 is preferably advanced-so that a length 58A of wire 58 extends approximately 1 centimeter out of the bottom end of movable jaw portion 98 (FIG. 17C). In this respect it will be appreciated that, as suture wire 58 leaves fixed jaw portion 96 and engages subject portions 110, 112, the fixed jaw portion's channel 108, the cutting bar's opening 106 and the fixed jaw portion's channel extension 108A will support the thin suture wire so as to enable the suture wire to penetrate subject portions 110, 112.
  • [0075]
    Once this has been done, jaw closing actuator 22 is released so as to permit movable jaw portion 98 to return to its “open” position relative to fixed jaw portion 96, and then wire advance button 20 is used to pay out additional suture wire 58 as the distal end of suturing instrument 10 is stepped back (e.g., by about a centimeter or so) from subject portions 110, 112 (FIG. 17D).
  • [0076]
    Then jaw closing actuator 22 is used to move jaw portion 98 back into engagement with fixed jaw portion 96 once more (FIG. 17E).
  • [0077]
    Next, left-thumb-actuated rotation button 26, or right-thumb-actuated rotation button 28, is used to rotate shaft 16 and hence end effector 18. This causes suture wire 58 to twist on itself, initially creating a relatively large loop 116 (FIG. 17F) of suture wire 58 extending from subject portions 110, 112 toward suturing instrument 10. However, as rotation button 26 and/or rotation button 28 is used to rotate shaft 16 (and hence end effector 18) more and more, the loop 116 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 end effector 18 is rotated, the greater the amount of twisting of suture wire 58, and the greater the force holding subject portions 110, 112. In this respect it will also be appreciated that suture wire 58 is preferably carefully selected with respect to its flexibility relative to the strength of subject portions 110, 112. In particular, suture wire 58 is chosen so as to have a flexibility such that the suture wire will twist, and loop 116 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.
  • [0078]
    Once suture wire 58 has been tightened to the desired degree, rotation of shaft 16 and end effector 18 is stopped, i.e., by releasing button 26 or button 28. Then wire cutting actuator 24 is depressed (e.g., it is pulled back toward handle 14) so as to pull cutting bar 104 proximally and thereby sever the suture wire 58 as the suture wire emerges from the fixed jaw portion's channel 108 and enters the cutting bar's opening 106 (FIG. 17H and FIG. 16). This action separates the deployed suture wire extending through subject portions 110, 112 from the suture wire remaining in wire supply cartridge 30, wire guide 76 and the fixed jaw portion's channel 108.
  • [0079]
    Then wire cutting actuator 24 is released, allowing biasing spring 69 to return cutting bar 104 to return to its distal position, and then jaw closing actuator 22 is released, allowing movable jaw portion 98 to move away from fixed jaw portion 96. Suturing instrument 10 may then be removed from subject portions 110, 112, which action will pull wire length 58A from movable jaw portion 98 (FIG. 17I).
  • [0080]
    The deployed suture wire 58 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).
  • [0081]
    It will be appreciated that suturing instrument 10 will have application in a broad range of different suturing operations. More particularly, it will be appreciated that suturing instrument 10 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.
  • [0082]
    It will also be appreciated that suturing instrument 10 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.).
  • [0083]
    Among other things, it is believed that suturing instrument 10 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.
  • [0084]
    Looking next at FIGS. 18 and 19, it will be seen that where the fixed jaw portion's channel 108 is disposed so as to be substantially aligned with the center of cutting bar 104 (FIG. 18), suture wire 58 will be cut with a relatively flat leading end 58B (FIG. 19). However, it has sometimes been found helpful to provide suture wire 58 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's opening 113. To this end, it has been found that moving the fixed jaw portion's channel 108 off-center relative to cutting bar 104 (FIG. 20) will cause the leading end 58B of suture wire 58 to be formed with a relatively sharp tip 58C (FIG. 21).
  • [0085]
    It is also possible to use suturing instrument 10 to ligate a subject rather than to pass a suture through the subject. For example, suturing instrument 10 might be used to ligate a blood vessel with suture wire 58. In this case, suturing instrument 10 is deployed so that suture wire 58 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.
  • [0086]
    By way of example but not limitation, in a typical ligating operation, movable jaw portion 98 is first opened relative to fixed jaw portion 96. Then suturing instrument 10 is positioned about the subject so that when movable jaw portion 98 is thereafter closed toward fixed jaw portion 96, the fixed jaw portion's channel 108 and the movable jaw portion's opening 113 will both lie on the far side of the subject. The movable jaw portion 98 is then closed against the fixed jaw portion 96, and suture wire 58 is passed from fixed jaw portion 96 to movable jaw portion 98, i.e., around the far side of the subject. The movable jaw portion 98 is then opened, and suture wire 58 is payed out as the instrument is stepped back from the subject. Then the movable jaw portion 98 is again closed against the fixed jaw portion 96. The shaft of the instrument is then rotated so as to form, and then close down, the ligating loop. Then cutting bar 104 is activated so as to cut the ligating loop from the remainder of the suture wire still in the tool, the movable jaw member 98 is opened, and the instrument is withdrawn from the surgical site. The deployed suture wire 58 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, where instrument 10 is to be used for ligating purposes, fixed jaw portion 96 and movable jaw portion 98 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 member 98 might be formed with a recess, intermediate its jaw linkage pin 100 (FIG. 15) and its opening 113, for accommodating the subject, whereby to prevent compressing the subject when movable jaw member 98 is moved into engagement with fixed jaw member 96.
  • [0087]
    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 wire 58 may comprise stainless steel, titanium, tantalum, etc.
  • [0088]
    If desired, suture wire 58 may also be coated with various active agents. For example, suture wire 58 may be coated with an anti-inflammatory agent, or an anti-coagulant agent, or an antibiotic, or a radioactive agent, etc.
  • [0089]
    Looking next at FIG. 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.
  • [0090]
    A piezoelectric element 200 is placed at the outside radius of the wire guide path 108 at the right angle bend in the fixed jaw portion 96 just before where the wire enters the tissue. The piezoelectric element 200 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.
  • [0091]
    Looking next at FIG. 23A, it will be seen that, in some circumstances, the suture wire 58 may exit fixed jaw portion 96 with a curvature, due to the fact that suture wire 58 follows a curved channel 108 in fixed jaw portion 96. In some cases this curvature in the suture wire 58 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 fixed jaw portion 96 to miss the target opening 113 in movable jaw portion 98. In this case the curvature in suture wire 58 can present a significant problem. However, and looking now at FIG. 23B, it has been found that the profile of the cutting bar's opening 106 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 fixed jaw portion 96. Alternatively, the profile of the fixed jaw portion's channel 108 may be modified, adjacent to cutting bar 104, 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 fixed jaw portion 96. Futhermore, and looking now at FIG. 23C, the mouth of the movable jaw portion's opening 113 may be enlarged to help capture a suture wire deviating from a straight path.
  • [0092]
    Looking next at FIG. 24, it will be seen that one ore more legs 300 may be provided on suturing instrument 10, wherein legs 300 help stabilize the tissue during suturing.
  • [0093]
    And looking next at FIG. 25, it will be seen that a grasper 400, comprising jaws 405 and 410, may be added to suturing instrument 10 to help stabilize the tissue during suturing.
  • [0094]
    If desired, the end effector 18 of suturing instrument 10 may be constructed so as to have two movable, opposing jaws, rather than one fixed jaw and one movable jaw as described above.
  • [0095]
    Also, if desired, shaft rotation motor 60 and thumb buttons 26, 28 may be configured so that depressing one button (e.g., button 26) will cause end effector 18 to rotate in one direction (e.g., clockwise), and depressing the other button (e.g., button 28) will cause end effector 18 to rotate in the opposite direction (e.g., counterclockwise).
  • Further Constructions for the Wire Suturing Device
  • [0000]
    Other Suture Materials
  • [0096]
    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.
  • [0000]
    Collet Wire Drive Mechanism
  • [0097]
    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 collet wire drive mechanism 500 is shown in FIGS. 26A-26E. A spring 505 presses a collet collar 510 onto collet 515 which causes collet 515 to squeeze and hold wire 520. The taper of collet 515 is such that collet collar 510 is now stuck on the collar and no longer needs spring force bias to maintain the hold on wire 520. As the collet assembly 500 is moved forward by a force against the push collar 510, wire 520 is also moved forward until the collet collar 510 hits a collet collar stop 525 at the end of the advance stroke. At this point collet collar 510 is pushed off the collet 515 thereby releasing the hold on wire 520 so that as the collet assembly 500 moves backwards wire 520 remains in its advanced position. As the collet assembly 505 moves all the way back, collet collar 510 encounters the collet collar backstop 530 which pushes collar 510 back onto the collet 515 with the force of spring 505 so that wire 520 is held again and ready for another thrust forward. Various methods can be used to advance push collar 535 such as a pivoting manual lever mechanism 540 and a motorized cam system 545, both shown in FIGS. 26A-26E.
  • [0098]
    As the collet 515 advances, wire 520 in front of collet 515 needs to be supported to prevent wire 515 from buckling, yet the support must shrink and expand with the motion of the collet movement. As shown in FIGS. 27A-27D, methods for providing this support are to place wire 520 inside a small coil spring 550, a tube 555 of an elastomeric material, or a telescoping tubes 560.
  • [0099]
    Because collets for very small wires can be difficult to manufacture, small pieces of plastic tubing 565 with a small internal diameter sufficient to accommodate the wire with some clearance, can be placed in collet 515 as an interface between collet 515 and the wire. The deformability of the plastic tubing will allow collet 515 to collapse plastic tube 565 enough to press and hold the wire (see FIGS. 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. When collet 515 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. As collet 515 moves backwards after advancing the wire, the wire will remain in the incrementally forwarded position.
  • [0000]
    Wire Cutting
  • [0100]
    It is advantageous to cut wire 520 with a minimum of force since the mechanism for cutting wire 520 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 (see FIGS. 29-29D, 30).
  • [0101]
    It is also advantageous to provide wire 520 with a sharp tip 580 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-shaped cutting surface 570 into wire 520 from both sides will cause wire 520 to have a tip 585 with sloped sides making it sharper for tissue penetration (see FIGS. 29-29D). A cutting bar 590 that shears the wire 520 at an angle to the length of wire 520 will create a correspondingly angled tip 595. This could be done for example if the wire path 600 traversed a circular cutting bar nearer one side of the bar rather than the middle (see FIGS. 31 and 31A).
  • [0000]
    Wire Feed Stop
  • [0102]
    The moveable side of the jaw that accommodates the distal end of wire 520 as it passes through tissue 605 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 a physical end 610 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 an optical interrupter 615, pressure switch 620, 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 (see FIGS. 32A-32H).
  • [0000]
    Jaw Surfaces that Enhance Tissue Grasping
  • [0103]
    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 have undulations 625, abrasive surfaces 630, or concave areas 635 that create a ridge at the tip of the jaw. The jaw may also be tapered to a pointed tip 640 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 (see FIGS. 33A-33G).
  • [0000]
    Jaw Feature that Facilitates Wire Penetration
  • [0104]
    A raised portion 645 on the jaw surface where wire 520 exists and also on the opposite jaw surface through which wire 520 passes after penetrating tissue 605, can reduce the travel distance of the wire. This reduces the chances that the wire will deviate from the intended path through the tissue (see FIGS. 34A and 34B).
  • [0000]
    Tubular Ligation
  • [0105]
    It is often necessary to surgically occlude a tubular structure 650 by tying a suture 655 tightly around the circumference so that the lumen is collapsed and closed. By placing a space 660 in the jaw proximal to where wire 520 emanates, a tubular structure 650 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 (see FIGS. 35A-35D).
  • [0000]
    Wire Coloring
  • [0106]
    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.
  • [0000]
    Wire Coatings
  • [0107]
    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.
  • [0108]
    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.
  • [0000]
    Shaft that Allows Angled Orientation of Jaw
  • [0109]
    The surgical field often requires that the device access an area that is not in a straight line from the entrance point of the Instrument 662. One method for doing this with the present device is to give the outer tube 665 of the device shaft a permanent bend θ and allow all the inner tubes 670 (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 (see FIGS. 36A-36C and 37A-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/pull elements 675 in a wall 680 of the outer tube of the shaft (see FIGS. 38A and 38B).
  • [0000]
    Wire Disposable Details
  • [0110]
    The instrument will use single-use quantities of wire 520 that are sterile and disposable. The disposable consists of a plastic container 685 that contains the wire and a tube 690 that supports wire 520. Tube 690 projects from the middle of container 685 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 (see FIGS. 39 and 40). To install the disposable, a lever 695 on the instrument is moved displacing one of the drive wheels 700 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 that tube 690 passes between the wheels and all the way up to the jaw where it interfaces with another tube 705 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.
  • [0111]
    The wire tube has a section 710 at the position of the drive wheels that is cut away on both sides to expose the wire to the drive wheel surfaces 700 (see FIGS. 40 and 41). This geometric arrangement allows wire 520 to be supported laterally when it is between drive wheels 700. 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.
  • [0112]
    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 (see FIGS. 39-41).
  • [0000]
    Lubricious Wire Pathways
  • [0113]
    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.
  • [0000]
    Wire Drive Wheels with Enhanced Frictional Force against the Wire
  • [0114]
    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 the surface 715 of the drive wheel 700A. 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 (see FIG. 42).
  • [0115]
    Another means of increasing the frictional force is to increase the area of contact between drive wheel 700A and wire 520. This could be accomplished by placing a groove 720 into the drive wheel surface that wire 520 can partially fit into so that the drive wheel 700A also contacts the sides of wire 520. 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 have multiple drive wheels 725 in series driven by a common or separate linkage (see FIGS. 43A-43C).
  • [0000]
    Jaw Rotational Symmetry
  • [0116]
    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.
  • [0000]
    Means to Grab Separated Pieces of Tissue
  • [0117]
    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 fang 740 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 (see FIGS. 44A-44C). It is also possible for the two sides of the jaw to close independently against a central anvil 745. Each side of the jaw would grasp a piece of tissue between it and anvil 745 allowing the pieces 730A, 730B to be grabbed separately and brought together. The tip of the anvil would have a slit 750 in the middle of the end, open to the distal edge that would allow wire 520 to pass through tissue 730A, 730B. After wire 520 had been thus passed, the jaws would be released and pulled away for the steps of grabbing wire 520 and twisting them. Slit 750 in central anvil 745 would allow wire 520 to exit the front end during this step (see FIGS. 45A-45F).
  • Further Modifications
  • [0118]
    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.
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Classifications
U.S. Classification606/148
International ClassificationA61B17/04, A61B17/12, A61B17/068, A61B17/00, A61B17/064
Cooperative ClassificationA61B17/062, A61B17/0483, A61B2017/0646, A61B2017/00004, A61B17/064, A61B17/0469, A61B17/12013, A61B17/068, A61B17/0491
European ClassificationA61B17/04H, A61B17/04E, A61B17/068, A61B17/064, A61B17/062
Legal Events
DateCodeEventDescription
Mar 8, 2005ASAssignment
Owner name: DVL AQUISITION SUB, INC., RHODE ISLAND
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Effective date: 20040630
Mar 21, 2005ASAssignment
Owner name: ONUX MEDICAL, INC., NEW HAMPSHIRE
Free format text: RELEASE OF SECURITY AGREEMENT;ASSIGNOR:FLEET NATIONAL BANK;REEL/FRAME:015931/0121
Effective date: 20041220
Owner name: ONUX MEDICAL, INC.,NEW HAMPSHIRE
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Effective date: 20041220