AU775823B2

AU775823B2 - Finger-guided surgical instrument

Info

Publication number: AU775823B2
Application number: AU61786/00A
Authority: AU
Inventors: Gil Levy; Moshe Maroko
Original assignee: Urogyn Ltd
Current assignee: Urogyn Ltd
Priority date: 1999-08-12
Filing date: 2000-07-24
Publication date: 2004-08-19
Anticipated expiration: 2020-07-24
Also published as: EP1210017A1; EP1210017A4; JP2003523789A; IL148051A0; KR20020027543A; CA2380572A1; AU6178600A; WO2001012084A1

Description

WO 01/12084 PCT/IL00/00439 1 FINGER-GUIDED SURGICAL INSTRUMENT FIELD AND BACKGROUND OF THE INVENTION The present invention relates to surgical instruments, and more particularly, to finger-guided surgical instruments, for performing extra as well as intrabody surgical tasks, such as, but not limited to, cutting, grasping, suturing, sample collection by capillary forces or aspiration, placement of anchors and the like, especially in body locations of limited minimal-invasive accessibility. The present invention further relates to o0 surgical procedures in which one or more finger-guided surgical instrument of the present invention are used to cut, grasp, suture, collect a sample, place anchors and the like, especially in body locations of limited minimal-invasive accessibility.

For years, there has been a discernible, clear tendency in surgery and invasive diagnosis, especially, but not exclusively, in abdominal, joint, vaginal, in-utero and brain, surgeries or diagnoses, to develop procedures that would reduce the need for major access-providing incisions with their concomitant requirements of general anesthesia, extended hospitalization and increased infection hazard. One step in this direction was the introduction of endoscopy and laparoscopy, which, through provision of minimal incision in, the abdominal wall of joint covering skin, permits the introduction into the abdominal cavity or joint of a miniature television camera including a light source, as well as of various surgical instruments.

PCT/US97/11494 teaches a number of surgical instruments which can be mounted directly on a surgeon's fingertips in a way that the surgeon can insert his or her hand into the patient through a minimal incision to perform surgical procedures, and also to use his or her fingers to manipulate tissues, thus enabling the surgeon to perform the procedures with the benefits of minimally invasive surgery, but with 2 much greater tactile sense, control; and ease of manipulation. However, these surgical instruments are carried by a finger and operated by the thumb, thereby are not applicable for procedures in which a single finger is employed for tactile sensing an operated intrabody location; (ii) include an operating head which permanently extends far beyond the fingertip on which the surgical instrument is mounted, which limits the tactile sensing of the surgeon; and/or (iii) prevent tactile sensing by the instrument carrying fingertip altogether.

Several surgical procedures are performed while the surgeon uses tactile information collected by a single fingertip for tactile sensing the intrabody site to be surgically operated prior to the actual surgical operation. Several non-limiting examples of such procedures are described in detail in the sections that follow. However, once the surgeon has collected the tactile information, surgical instruments are to be blindly S" 15 operated intrabodily. Such instruments, in most part, engage both the hands of the surgeon. Evidently, blindly operating surgical instruments intrabodily based on finger tip tactile information collected earlier may prove inconvenient, inaccurate and may increase the chance of inadvertently harming the patient.

20 There is thus a widely recognized need for, and it would be highly advantageous to have, finger-guided surgical instruments devoid of the .limitations associated with the prior art instruments and which enable a surgeon to use a single finger to both collect tactile information from an intrabody location to be surgically operated and to surgically operate that intrabody location with a finger-guided surgical instrument.

SUMMARY OF THE INVENTION According to one aspect of the present invention there is provided a finger-guided surgical instrument, comprising a thimble-like element being adapted to surround at least a portion of a surgeon's finger while at 3 least partially exposing the ventral tactile portions of the distal phalanx thereof, so as to enable the surgeon to tactile sense a body location to be treated; an ejectable surgical tool being engaged within a housing being formed within, or connected to, a wall of the thimble-like element; and a mechanism for ejecting the surgical tool from the thimble-like element, so as to enable the surgeon to operate the body location, the mechanism including a first portion engaged within the housing and which is in contact with the ejectable surgical tool, a second, remote, portion which is adapted to extend out of the patient's body, and a flexible cable in a tube connecting the first portion to the second portion, the second remote portion being operable by a free hand of the surgeon so as to eject the surgical tool from the thimble-like element.

According to further features in preferred embodiments of the invention described below, the finger-guided surgical instrument further .o* S 15 comprises an adapter insertable between the thimble-like element and the surgeon's finger, so as to adapt the guided surgical instrument to fingers of different size.

According to still further features in the described preferred embodiments the mechanism further serves for withdrawing the ejectable 20 surgical tool back into the housing.

According to still further features in the described preferred embodiments the wall is a side wall of the thimble-like element.

According to still further features in the described preferred embodiments the wall is a front wall of the thimble-like element.

According to still further features in the described preferred embodiments the thimble-like element is constructed so as to be mounted over a dorsal side of the distal phalanx of the surgeon's finger, thereby exposing the entire ventral tactile portions of the distal phalanx.

According to still further features in the described preferred embodiments the thimble-like element is constructed so as to fully surround 4 the distal phalanx and expose the tip of the ventral tactile portion of the distal phalanx.

According to still further features in the described preferred embodiments the thimble-like element is constructed so as to be mounted over a ventral side of the distal phalanx of the surgeon's finger and expose the tip of the ventral tactile portion of the distal phalanx.

According to still further features in the described preferred embodiments the surgical tool is ejectable in a direction generally in extension of a longitudinal axis of the thimble like element.

According to still further features in the described preferred embodiments the surgical tool is ejectable in a circular path.

According to still further features in the described preferred embodiments the circular path on a plane which substantially parallels a plane traversing the surgeon's finger from top to bottom.

15 According to still further features in the described preferred embodiments the circular path on a plane which substantially parallels a plane traversing the surgeon's finger from side to side.

According to still further features in the described preferred embodiments the circular path on a plane which is substantially 20 perpendicular to the longitudinal axis of the surgeon's finger.

According to still further features in the described preferred embodiments the surgical tool is selected from the group consisting of a surgical needle, a needle carrying a surgical anchor ejectable therefrom, a puncturing device, an injection needle, a capillary, a puncturing capillary, a miniaturized surgical grasper, miniaturized surgical scissors, a miniaturized blade and an aspiration capillary.

According to still further features in the described preferred embodiments the finger-guided surgical instrument further comprises a reporting mechanism for reporting at least one situation selected from the group consisting of a full ejection of the surgical tool, a full withdrawal of the surgical tool, a degree of ejection of the surgical tool and a degree of withdrawal of the surgical tool.

According to another aspect of the present invention, there is provided a finger-guided surgical instrument, comprising a thimble-like element being adapted to surround at least a portion of a surgeon's finger while at least partially exposing the ventral tactile portions of the distal phalanx thereof, so as to enable the surgeon to tactile sense a body location to be treated; an ejectable surgical tool being engaged within a housing being formed within, or connected to, a wall of the thimble-like element; and a mechanism for ejecting the surgical tool from the thimble-like element, so as to enable the surgeon to operate the body location, the mechanism including a ratchet member being disposed between the thimble-like element and the surgeon's finger so as to eject the surgical tool from the thimble-like element by twisting back and forth the surgeon's 1. 15 finger.

The present invention successfully addresses the shortcomings of the presently known configurations by providing finger guided surgical instruments having ejectable surgical tools which maintain the user finger's ability for palpation.

••go: go ••go.

WO 01/12094 W001J2084PCTIEiLOO/00439 6 BRIEF DESCRIPION OF THE DRAWINGS The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way s of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the drawings: FIG. 1 is a front view, in partial cross-section, of a first embodiment of the needle driver according to the present invention; FIG. 2 is a top view, in partial cross-section, of the needle driver of Figure 1; FIG. 3 is a front view,, in partial cross-section, of the housing of the. needle driver, 20 FIG. 4 is a top view of the housing; FIG. 5 is a view in cross-section along plane V-V in Figure 3; FIG. 6 represents an enlarge detail of the area encircled in Figure 3; FIGs. 7, 8 and 9 represent partially cross-sectional front, top and 25 side views, respectively, of the thimble-like grip; FIGs. 10 and 11 show a front view in cross-section, and a bottom view, respectively, of the ratchet of the needle driver; FIG. 12 is a greatly enlarged, perspective view of the needle pusher of the invention; WO 01/12084 PCT/ILOO/00439 7 FIG. 13 is a similar view of the needle puller, FIGs. 14 and 15 are a front view and a side view in cross-section, respectively, of the entrance guide; FIGs. 16 and 17 are similar views of the exit guide; FIGs. 18 and 19 are a front view in cross-section and a side view, respectively, of the needle driver cap; FIG. 20 is a partially cross-sectional front view of a dual needle driver according to the present invention; FIG. 21 is a side view of the needle driver of FIG. 20 in the 0o direction of arrow A; FIG. 22 is a partially cross-sectional front view of the housing of the needle driver of Figures 20 and 21; FIG. 23 is a partially cross-sectional top view of the housing; FIG. 24 is a side view of the housing in the direction of arrow B; FIG. 25 is an elevational view of the needle pusher, FIG. 26 is a cross-sectional view of the needle pusher of Figure FIG. 27 is a partial view of the needle pusher in the direction of arrow A; FIG. 28 is a view of the detail of FIG. 27 in the direction of arrow

B;

FIG. 29 is a perspective view of the needle puller, also indicating the position of the pusher-catching pawl; FIG. 30 is an elevational view of the pusher-catching pawl; 25 FIG. 31 is a cross-sectional view, along plane XXXI-XXXI, of the pawl of Figure FIG. 32 illustrates a needle-retaining ring segment; FIG. 33 is an elevational view of a variant of the needle pusher of Figure WO 01/12094 WO 0112084PCTILOOIO439 8 FIG. 33A is a schematic representation of the vagina and the urethra after a surgical procedure is completed using any of the devices described in figures 1-33; FIGs. 34 and 35 are perspective views of finger-mounted devices s for guiding a surgical instrument according to the Present invention; FIGs. 36-46 are cross sectional views of surgical instruments which can be guided using the finger-mounted devices of Figures 34-35, including a surgical needle, a needle carrying a surgical anchor ejectable therefrom, a puncturing device, an injection needle, a capillary, a puncturing capillary, a miniaturized surgical grasper, a miniaturized aspiration capillary, miniaturized surgical scissors and a miniaturized blade; FIG. 47 is a perspective view of a finger-guided suturing device according to another aspect of the present invention, in which an ejected is needle follows a circular path which is on a plane which parallels a plane traversing a surgeon's finger from top to bottom; FIG. 48 is a perspective view of a finger-guided suturing device *too.:according to another aspect of the present invention, in which an ejected needle follows a circular path which is on a plane which is perpendicular to the surgeon's finger, FIG. 49 is a cross sectional view of a housing engaged in a side wall of the device of Figure 47 or a front wall of the device of Figure 48; FIGs. 50A and 50B show semi-circular needles employed in the r i~e devices of Figures 47-48; FIGs. 51-54A are cross sectional views of stes in the ejection and withdrawal of a semi-circular needle from and into the device of Figure 47 or Figure 48 according to one embodiment of the present invention, according to which a hinge of a rotating arm pushing or pulling the needle is colocalized with a virtual axis around which the needle is translocated.

WO 01/12084 WO 0112084PCTJLOOIO439 9 FIG. 55 is a cross sectional view of extendible-retractable rotating arm used for pushing or pulling the needle according to another embodiment of the present invention; FIGs. 56-59 are cross sectional views of steps in the ejection and withdrawal of a semi-circular needle from and into the device of Figure 47 or Figure 48. according to another embodiment of the present invention, according to which the hinge of the extendible-retractable rotating arm pushing or pulling the needle is localized in offset with respect to the virtual axis around which the needle is translocated, to thereby achieve farther ejection of the needle.

FIG. 60 is a cross sectional view of a mechanical/electrical remote control device used to operate and/or monitor the operation of the devices of Figures 47 and 48, showing a rotating actuator and one end of a rotation relay engaged thereby and which is used for rotating the rotating 15 arm which pulls or pushes the needle, in addition, a portion of a reporting mechanism which is used for monitoring the needle ejection process is shown; FIG. 61 shows another portion of the monitoring mechanism; FIG. 62 shows a suture inserted in a tissue using the devices of Figures 47or 48; FIG. 63 is a perspective view of a finger-guided sampling device according to another aspect of the present invention, showing a capillary and a puncturing device thereof in their withdrawn position; FIG. 64 is an enlarged perspective view of a portion of the fingerguided sampling device of Figure 63, showing the capillary and the puncturing device thereof in their ejected position; FIG. 65 is a top enlarged view of remote actuators employed for ejecting/withdrawing the capillary and the puncturing device; WO 01/12084 PCT/LLO/00439 FIG. 66 is a cross sectional view of a capillary having sharp edges and which is equipped with a reporting mechanism for reporting the presence of electro conductive collected sample therein; FIG. 67 shows the device of Figure 63 mounted on a surgeon's pointing finger and used to sample a fetal scalp during labor, while- the sleeve thereof is ejected, wherein C is the cervix and S is the fetal scalp; FIG. 68 is a perspective view of an anchor implanting device according to the present invention; FIG. 69 is a cross sectional view of a single housing engaged in a wall of the device of Figure 68; FIG. 70 is a cross sectional view of a remote rotating actuator employed in the device of Figure 68; FIG. 71 is a cross sectional view of a remote translating actuator employed in the device of Figure 68; FIG. 72 is a cross sectional view of an anchor guiding element and :an anchor guided thereby of the device of Figure 68; FIG. 73 is a cross section view of the anchor guiding element and the anchor guided thereby being in the housing of the device of Figure 68; FIG. 74 is a cross section view of the anchor guiding element and the anchor guided thereby being ejected from the housing of the device of Figure 68, while the anchor is ejected from the guiding element and anchored in a tissue; and FIGs. 75-76 are perspective views of adapters according to the present invention.

DESCRIPTON OF THE PREFERRED

EMBODIMENTS

The present invention is of finger-guided surgical instruments which, can, be used to perform extra as well as intrabody surgical tasks, such as, but not limited to, cutting, grasping, suturing, sample collection WO 01/12084 PTIO/03 PCT/11,00/00439 by capillary forces or aspiration, placement of anchors and the like.

Specifically, the present invention can be used to perfo rm surgical tasks in body locations of limited minimal-invasive accessibility. The present invention is further of surgical procedures in which one or more fingerguided surgical instrument of the present invention are used to cut,. grasp, suture, collect a sample, place anchors and the like, especially in body locations of limited minimal-invasive accessibility.

The principles and operation of the instruments and procedures of the present invention may be better understood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, it. is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the 15 drawings. The invention is capable of other embodiments or of being .practiced or carried out in various ways. Also, it is to be understood that phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

Referring now to the drawings,. Figures 1-33 relate to a fingerguided suturing device according to one aspect of the present invention.

Figures 1 and 2. show a frontal view and a top view, respectively, of a first embodiment of this aspect of the present invention. These assembly drawings are intended to show the relative positions of the different components of the device, while the components themselves are :25 illustrated in Figures of their own, as further detailed in the following sections.

It should be noted that the cross-sectional portions of Figure 2 are not located in a common plane. Portions A are produced by cross-section allong plane A-A in Figure 1, while portion B is produced by crosssection along plane B-B in Figure 1.

WO 01/12084 WO 0112084PCT/EL,00100439 12 The first embodiment of the finger-guided suturing. device according to the present invention comprises a housing 2, a thimble-like finger grip 4 rotatably fitting the inside of housing 2, an arcuate ratchet 6 fixedly attached to thimble-like finger grip 4, a substantially semi-circular surgical needle 8, to the rear end of which is fixedly attached a length of suture 10, a needle pusher 12 having a pawl 14 adapted to interact with ratchet 6, a needle puller 16 having a pawl 18 adapted to interact with ratchet 6, a needle catch 20 cooperating with needle puller 16, a needle exit guide 22, a needle entrance guide 24, a cap 26 and a helical spring 28.

Seen in Figures 3-5 is housing 2, which geometrically is substantially in the shape of a hollow cylinder, part of which has been cut away along a plane substantially parallel to, but radially offset from, an axial plane of the cylinder, as is clearly shown in Figure 4. The hollow section thus subtends an angle larger than 1800 ***The bore of housing 2 is seen to have three sections: an upper, cylindrical section 30, a lower, cylindrical section 32, and a tapering, intermediate section 34 connecting the two cylindrical sections. Further shown is an internal, peripheral groove 36 located near the lower end of 20 housing 2 and serving to guidingly accommnodate two lugs integral with finger grip 4 (Figure 7) and permitting the latter one degree of freedom in rotation. Two further grooves 38 (of which only one is shown in Figure 3) cut. across grooves 36 and extend beyond them, facilitating the .introduction of finger grip 4 upon assembling the device and also serve a further purpose, to be explained further below. The location of grooves 38 can be seen in Figure Near the upper end of housing 2, there are shown a first peripheral groove 40 and, somewhat above it, a second peripheral groove 42.

Groove 40, as will be explained further below in greater detail, WO 01/12084 WO 0112084PCTIHM/0IO439 13 accommodates substantially semi-circular surgical needle 8; groove 42 serves to guide two further components in their movement: needle pusher 12 and needle puller 16.

The enlarged detail of Figure 6 shows groove 40 and groove 42 of housing 2, as well as ghosted-in needle driver 12 which, together with groove 40, defines a duct 46 which guides needle 8 (Figures 1 and 2) during the surgical procedure. Shoulder 47 (Figures 3 and 6) serves as abutment for cap 26 (Figure 18).

In Figure 4, there is shown an area 49 which has been cleared of i0 the collar comprising grooves 40, 42 -down to shoulder 47, to provide space for entrance guide 24 (Figures 14 and Represented in Figures 7 to 9 is finger grip 4, the thimble-like, cut-open sleeve located inside housing 2 that accommodates and grips the distal phalanx of the surgeon's index finger, leaving its ventral portion at least partly exposed for palpation. Also shown are two lugs 44 which, as :mentioned above, are seated inside groove 36 in housing 2 and restrain the finger-imparted movement of finger grip 4 to rotary movemnent only, except when lugs 44 are brought into alignent with grooves 38 of housing 2 (Figure in which situation finger grip 4 is also capable of a 20 short axial movement relative to housing 2, for a purpose to be explained fur-ther below.

*:.Figures 10 and 11I represent a ratchet 6 fixedly attached to, or integral with, finger grip 4. The purpose of ratchet 6 is to convert the reciprocative rotational motion of the surgeon's finger into an 25 intermittent, unidirectional advance of surgical needle 8 (Figures 1 and Ratchet 6 is seen to consist of a body 48, which carries on its underside an arcuate arrangement of ratchet teeth 50 subtending an angle of about 1800D, and on its upper side, a rod 52, the purpose of which will become apparent further below.

WO 01/12084 PTIO/03 PCr/RM/00439 14 Surgical needle 8 is of a substantially semi-circular shape and, near its sharp point, is provided with a notch 9 that is instrumental in returning needle 8 into housing 2 after completion of the stitch. The other end of needle 6 is provided with a bore, to which is attached a length of suture material Figure 12 represents needle pusher 12, a nose 52 of which moves along and is guided by groove 42, as is clearly shown in Figure 6.

Pushing projection 54 moves in duct 46 (Figure 6) and is seen to engage the rear end of needle 8, the suture passing through hole 56. In assembly, the elastically resilient pawl 14 is pressed against teeth 50 of ratchet 6.

When the surgeon rotates his finger in the counter-clockwise direction, one of the ratchet teeth 50 engages pawl 14, whereby needle 8 is pushed along by pawl 14, needle pusher 12 and projection 54. The angular range over which the surgeon can twist his finiger is of course limited (30-40O0)- At the end of the rotary motion, the finger returns in the clockwise direction to its original position. During this return movement, ratchet teeth 50 disengage from pawl 14 due to the slant of the latter, and needle pusher 12 remains stationary, in spite of the rotary movement of' finger grip 4, and is again moved only when the surgeon's finger renews its "working stroke" in the counter-clockwise direction.

Figure 13 represents needle puller 16 and its pawl 18. Needle :puller 16 is quite similar to pusher 12, except that projection 54 is replaced by a catch 58 which, as can be seen in Figure 13, fits notch 9 in ghosted-in needle 8. Also seen is a slanting hole 60, through which suture 10, coming from the rear of needle 8, leaves the suturing device.

From the moment needle 8 emerges from housing 2 via exit guide 22 and its flaring guide surface 23 (Figures 2, 16, 17), completes the stitching operation and fully returns into housing 2 via entrance guide 24 and its flaring guide surface 25 (Figures 2, 14, 15), needle movement is WO 01/12084 WO 0112084PCTJJL,00100439 divided between needle pusher 12 and needle puller 16. At the beginning of the stitching procedure, needle puller 16 is located close to entrance guide 24 (Figure its pawl 18 being beyond the reach of ratchet teeth (which extend only over an angular range of 180 Needle pusher 12, on the other hand, is located well within the effective range of ratchet teeth 50 adjacent to the rear end of needle 9, and, thus, with each movement of the surgeon's finger, will advance needle 8 until the latter will reenter housing 2 via entrance guide 24. An additional movement of needle pusher 12 will have the following results: catch 58 of needle puller 16 will engage in notch 9 of needle 8; and (ii) further movement of needle 8 by needle pusher 12 will drag needle puller 16, by means of catch 9, into the effective zone of ratchet teeth 50 and, at the same time, move itself beyond the reach of ratchet teeth Any further maneuver of the surgeon's finger will thus act on 15i needle puller 16 and draw needle 8 fully back into housing 2. When this has been accomplished, the stitch has been completed and the finger, as well as the needle driver, can be withdrawn, leaving the suture material anchored in the tissue and permitting the surgeon to tie up the stitch.

It will be appreciated that exit guide 22 and entrance guide 24 20 could also be integral parts of housing 2.

Figures 18 and 19 represent cap 26 (Figure 1) which, as mentioned :above, is seated against shoulder 47 (Figure 6) and defines and delimits ::the annular space in which needle pusher 12 and needle puller 16 move.

Cap 26 is cut open along a plane 62, common with housing 2. A fiurther cutting plane 64 is set back relative to plane 62. A bore 66 is a sliding fit to rod 52 of ratchet 6. As shown in Figure 1, a helical compression spring 28 is mounted on rod 52 and, abutting against ceiling 68 of cap 26, pushes ratchet 6 and finger grip 4 down as far as they will go, as far down as lugs 44 (Figure moving in groove 36 (Figure will permit WO 01/12084 PCTIO/00439 16 However, as already mentioned above, in a certain position of lugs 44 relative to slots 38 in housing 2, fing er grip 4 can be slightly lifted by pushing it up against the restoring force of spring 28. This feature can be used by the surgeon, should he decide to relocate needle 8 at a different spot, as long as notch 9 has not yet been captured by catch 58. All he has to do is to push up finger grip 4, which will cause the teeth 50 of ratchet 6 to lose contact with pawl 14. The surgeon can then move needle 8 back by pulling at the free end of suture The assembly of another embodiment of the -suturing device according to this aspect of the present invention is shown in Figures and 21. There are shown a housing 70, two' needles 72, two needle pushers 74, two needle pullers 76, two pawls 78, two exit guides 80, two entrance guides 82, two needle-retaining rings 84 and two cover plates 86.

1 Housing 70 (Figures 22-24) is substantially prismatic and comprises a bore 88, the lower part of which is cylindrical and the upper part of which, tapering and thimble-like, accommodates and firmly holds .the surgeon's finger. As in the previously-described embodiment, housing 70 is* cut along a plane parallel to, but distant from, the axis of 20 bore 88, so that the bore is exposed but still surrounds the surgeon's finger over more than 180 10. Housing 70 is completely symmetrical laterally of the axis of bore 88, so that whatever is described about one side thereof, pertains also to the other side.

*There are shown a substantially cylindrical depression or recess 25 (or rather, a segment of a recess, due to the cut-off front portion of housing 70) which houses most of the components described fuirther below, a central hole 92 and a groove 94 at the bottom of recess which accommodates needle 72. Also shown are two slots 96, 98, which accommodate exit guide 78 and entrance guide 80, respectively. Needle WO 01/12084 WO 01/12084PCT/RM00439 17 72, including notch 73, is identical to that described above with reference -to the previous embodiment, including suture 75 attached to its end.

Needle pusher 74 is seen in Figure 25 to consist of a central, substantially cylindrical portion 100, provided with a short shaft 102 (Figure 26) fitting hole 92 in housing 70, and a radially extending arm 104. The rear of arm 104 is provided with a curved ledge 106 (Figure 28), integral with which is a lug 108 having a hole 110 (Figure 27), through which passes suture 75. By means of a disk 112, the cylindrical portion 100 is turned into a reel or drum 101 onto which cords 115 can be i0 wound (see Figure 20), for a purpose to be explained ftirther below.

Figure 29 represents needle puller 76, also indicating the position of pawl 78. Further shown is catch 114, the purpose of which is to engage notch 73 of needle 72 when the latter is to be returned into housing 70 after the stitch has been completed. Also shown is a hole 15 116, which passes through needle puller 76 and through which suture is threaded. The initial position of needle puller 76 within housing 70 is clearly seen in Figures 20 and 21. While needle puller 76 and pawl 78 are shown here to be two different components, they can conceivably be produced as an integral whole, since, in any case, they must move 20 together.

0 Exit and entrance guides 80 and 82 respectively are essentially the same as those used in the previous embodiment, plates with a flaring lead-in and a hole for the needle to pass through. Needle-retaining ring segment 84 (Figure 32) fits into recess 90 (Figure 22) and, together with groove 94, defines the duct in which needle 72 moves. Recesses 90, as well as slots 96, 98, are covered by cover plates 86, which also serve to retain needle pusher 74, needle puller 76- and pawl 78 (Figure 20). A recess 118 in the lateral walls of housing 70 provides room into which WO 01/12084 WO 0112084PCTILOOIO439 18 pawl 78 is deflected when engaging needle pusher 74, as will be presently explained.

The above-described dual-needle embodiment of the suturing device according to this aspect of the present invention (Figures 20-3 1) is operated by the surgeon pulling a cord, using his other, free hand. To this end, two cords or threads are wound onto each drum 101 in two opposite senses of winding: for example, one blue cord for each drum 101 which, when pulled, will move its respective needle pusher 74 towards its exit guide 80, advancing its needle 72, and the other, a red cord for each i0 drum, which, when pulled, will move is needle pusher 74 towards its entrance guide 82.

After the proper location for the stitching operation has been found by palpation, the surgeon, by pulling both blue cords, thus advances needle pushers 74 towards exit guides 80, which serve also as stops to the advancing motion of needle pushers 74. By the time the surgeon feels that needle pushers 74 have been stopped, needle 72 have already commenced to re-enter housing 70 via entrance guides 82, with their notches 73 being captured by catches 114 (Figure 29). Pulling the red cords will return needle pushers 74 in a direction towards entrance 20 guide 82 and permit pawl return needle pushers 74 in a direction towards entrance guide 82 and permit pawl 78 to capture needle pushers 74 by engaging lugs 108 (Figure 27). Again pulling the blue cords will move needle pushers 74 again towards exit guide 80, dragging along pawl 78 aand needle pullers 76 (attached to, or integral with, pawls 78), thus, by 25 means of their catches 114, returning needles 72 into housing 70. The needle driver may then be withdrawn.

A variant of needle pusher 74 is seen in Figure 33. In the final stage of the proceedings, after the tip of needle 72, including notch 73, has already re-entered housing 70, the variant needle pusher 74A also WO 01/12084 WO 0112084PCTILOOIOO439 19 serves as needle puller, obviating the need for a separate needle puller 76 (Figure 29). In the original embodiment, pawl 78, being part of needle puller 76, merely serves as a mechanical link to hitch needle puller 76 to needle pusher 74, to enable the latter to complete withdrawal of needle s 72. In the above variant, needle pusher 74A functions also as needle puller 76 as soon as, the red cord having been pulled, paul 78A, now part of needle pusher 74A, engages needle notch 73 with its catch 114A.

Pulling now the blue cord will cause needle pusher 74A to move towards exit guide 80, dragging along needle 72 until it is fujlly inside housing Use of this variant also requires a slight modification in housing Recess 118 in the walls of housing 70, which provided room for pawl 78 to be deflected into, must now be transferred to the other side of the needle path.

Using a dual-needle driver makes it possible to simultaneously place one stitch on either side of the urethra, or to place, in two successive steps, two stitches on either side thereof, in which case the needle driver has to be replaced prior to the second step.

Figure 33A is a schematic representation of the vagina and the urethra after the surgical procedure is completed, with V indicating the 20 Vagina; U, the urethra; CL, Cooper's ligament; and S, suture stitches.

Obviously, both the first and the second embodiments of the suturing device according to this aspect of the invention will have to be produced in a range of different sizes to allow for the different sizes of the surgeons' fingers, or as further detailed hereinunder, adapters can be employed.

Although in the second, above-described embodiment of the suturing device, the needles are maneuvered by altemnatingly pulling cords,, embodiments are also envisaged in which the needles are manipulated by manual, electric or hydraulic actuators controlled by the WO 01112084 PCTILOOIOO0439 surgeon, examples of which, in context of the following aspects of the invention are provided hereinbelow.

The first embodiment of this aspect of the present invention was experimentally found limiting in applications requiring high~ precision, because in order to advance the needle, the surgeon has to rotate his or her finger, thus operating the ratchet. The second embodiment of this aspect of the present invention was found to be somewhat limiting because pulling the cords fails to give a surgeon a feeling of degree; and (ii) in some cases results in displacement of the device.

In search for improvements, the inventors realized several configurations which are fur-ther described hereinunder with reference to Figures 34-76, which, on one hand, broaden the scope of the invention, while, on the other hand, in preferred embodiments, overcome one or more of the limitations associated with the so far described aspects of the invention.

Thus, as shown in Figures 34-35, according to another aspect of the present invention there is provided a finger-mounted device 200 or :202 for guiding a surgical instrument. Device 200 or 202 comprising a thimble-like element 204 which is adapted to surround at least a portion of a surgeon's finger, while at least partially exposing the ventral tactile portions of the distal phalanx thereof, which tactile portions extending from the finger tip just underneath the nail and down to joint, so as to ~:enable the surgeon. to tactile sense a body location to be operated.

Thimble-like element 204 is formed with at least one longitudinal guiding tunnel or housing 206 formed within a wall thereof.

Longitudinal guiding tunnel 206 serves for guiding a surgical instrument therethrough,. so as to'enable the surgeon to operate a body location.

Thus, by mounting device 200 over the dorsal portion of the distal phalanx of a finger, the surgeon entire ventral tactile portions of the distal WO 01/12084 WO 0112084PCT/ILOOIO439 21 phalanx thereof, extending from the finger tip just underneath the nail and down to joint are exposed for tactile sensing, while, by mounting device 200 over the ventral portion of the distal phalanx of a finger, or alternatively, by mounting device 202 over the distal phalanx of a finger, only the surgeon finger'stip is exposed for tactile sensing. Thus, in both cases, the most nervated and therefore tactile sensitive potion of the ventral tactile portions of the distal phalanx of the surgeon's finger, i.e., the finger's tip, just underneath the nail, are exposed for tactile sensing.

The surgical tool insertable through housing 206 of device 200 or io 202 according to the present invention can be of any type. Examples include, but are not limited to, a surgical needle 210 (Figures 36, 37) or a needle 211 carrying a surgical anchor ejectable therefrom 211A (Figure 38) both holding a suture or cord 210A, a puncturing device 212 (Figure :11: 39), an injection needle 213, which is shown connected at a proximal end to a syringe 213A (Figure 40), a capillary 214 (Figure 41), a puncturing capillary 215, shown to have sharp distal edges 215A (Figure 46), a miniaturized surgical grasper 216 (Figure 42), a miniaturized aspiration capillary 217, shown connected to a syringe 217A (Figure miniaturized surgical scissors 218 (Figure 43) and a miniaturized blade 20 219 (Figure 44).

According to another aspect of the present invention there is provided a finger-guided surgical instrument which includes a thimblelike element 204 essentially as described above and which is, as described above, adapted to surround at least a portion of a surgeon's finger, while at least partially exposing the ventral tactile portions of the distal phalanx thereof, so as to enable the surgeon to tactile sense a body location to be operated. In contrast, with the construction of housing 206 of devices 200 or 202, the housing of the finger-guided surgical instrument according to this aspect of the present invention is occupied at WO 01/12084 PCT/IL00/00439 22 al times, as further detailed and exemplified below, by a surgical tool or a portion thereof, and a mechanism for its operation, Thus, the fingerguided surgical instrument further includes an ejectable surgical tool which is engaged within a housing formed within, or connected to, a wall of the thimble-like element; and a mechanism for ejecting the surgical tool from the thimble-like element, so as to enable the surgeon to operate a body location. Specific examples of finger-guided surgical instruments according to various aspects of the present invention are further described hereinunder, followed by general features which are preferably 0o common to all of the finger-guided surgical instruments of the present invention.

Thus, as shown in Figures 47-61, according to yet another aspect of the present invention there is provided a finger-guided surgical instrument which serves as a finger-guided suturing device. The device 15 includes a thimble-like element 300, which is adapted to surround a portion of a surgeon's finger, while exposing the ventral tactile portions of the distal phalanx thereof, so as to enable the surgeon to tactile sense a body location to be operated.

According to a preferred embodiment of this aspect of the present 20 invention thimble-like element 300 is constructed so as to be mounted over a dorsal side of the distal phalanx of the surgeon's finger, thereby exposing the entire ventral tactile portions of the distal phalanx including the tip.

The device according to this aspect of the present invention further includes an ejectable, substantially semi-circular, surgical needle 302 which is engaged within a housing 304, which is formed within, or connected to, a wall 306 of thimble-like element As shown in Figure 47, wall 306 can be a side wall of member 300, or alternatively, as shown in Figure 48, wall 306 can be a front wall of member 300. Needle 302 WO 01/12084 WO 0112084PCTIOOIO439 23 serves for holding and guiding a suture 308 which is attached at one end thereof to substantially semi-circular surgical needle 302. The suturing device according to this aspect of the present invention fuirther includes a mechanism 310 for ejecting surgical needle in a circular path through an ejection opening in housing from thimble-like element and thereafter withdrawing surgical needle back into thimble-like element through a withdrawal opening in housing, so as to enable the surgeon to suture body location.

Mechanism 310 of the suturing device according to this aspect of the present invention includes a substantially semi-circular channel 312 formed in housing 304 and connecting ejection and withdrawal openings 314 and which fully engages substantially semi-circular surgical needle 302 before its ejection and following its withdrawal, so as to direct substantially semi-circular surgical needle in circular path around a is virtual axis 316. Mechanism 310 further includes a remotely operated .***rotating arm 318 rotatably engaged in hosing 304 and rotatable about a hinge 320. Rotating arm*318 is designed to eject substantially semicircular surgical needle 302 through ejection opening 314 by pushing a rear portion 302A of substantially semi-circular surgical needle 302 and rotating arm 318 is further designed to withdraw substantially semi- 000 circular surgical needle 302 through withdrawal opening 314 by pulling a front portion 302B of substantially semi-circular surgical needle 302.

0 0 According to one embodiment of the present invention, and as 0 00 0 specifically shown in Figures 49, and 50-54A, virtual axis 316 and hinge 320 are co-positioned. However, according to another preferred embodiment of the present invention, and as specifically shown in Figures 56, and 59, virtual axis 316 and hinge 320 are offset, whereas rotating arm 318 is an extendible-retractable arm, which is shown isolated in Figure 55 to include a first, substantially hollow, segment 322 WO 01/12084 WO 0112084PCTIILO/00439 24 integrally formed with, or connected to, hinge 320 and including an extending spring element 324, and a second segment 326 extendiblyretractably accepted within the hollow of first segmnent 322, so as to be extended by the action of element 324 and retracted against the action of element 324. Segment 322 is preferably formed to include a stoppage so as to prevent the complete separation of segments 322 and 326. This latter configuration allows farther ejection of needle 302 in applications wherein such farther ejection is required. It will be appreciated that a configuration in which lesser ejection of needle 302 in applications wherein such lesser ejection is required is realizable, for example, by swooping the locations of hinge 320 and virtual axis 316. Alternatively, both hinge 320 and virtual axis 316 can be relocated farther away from openings 314 to otherwise achieve. a similar result.

:~:According to a preferred embodiment of the present invention is substantially semi-circular surgical needle 302 is formed with a notch 303 (Figures 50A-B) at front portion 302B. Notch 303 is designed to accept a distal end 319 of rotating armn 318. A second notch 305 (Figure can be formed at rear portion -302A of needle 302 which is also designed to accept distal end 319 of rotating arm 318. Alternatively, or 2o additionally, substantially semi-circular surgical needle 302 is formed with a blunt rear end 307 (Figure 50A-B) which is designed to be pushed e~g..by rotating arm 318.

H Remotely operated rotating arm 318 includes a rotating wheel 330 *:portion rotatable about hinge 320 and an arm portion 332 connected to, or integrally formed with, rotating wheel portion 330. Mechanism 310 further includes a remote rotation relay 334 which serves for relaying rotary motion from a remote rotatable actuator 336 to rotating wheel portion 330 for effecting rotation of rotating armn 318. According to a WO 01/12084 PCTILOOI0439 preferred embodiment, a flexible tube 338 connects between housing 304 and remote rotatable actuator 336, tube engaging remote rotation relay.

Thus, as shown in sequence in Figures 5 1-54A and in Figures 56- 59, in a starting position (Figures 51 and 56) needle 302 is fully engaged s within housing 304, such that no parts thereof protrude from thimble-like element 300. For operation, as shown in Figures 51 and 56, ann 318 is positioned so as to push rear portion 302A of needle 302 upon rotation.

As shown in Figures 52-53 and 57-58, arm 318 is rotated by operating actuator 336 so as to eject front portion 302B of needle 302 out of housing 304 through ejection opening 314 until' rear front 302B approaches withdrawal opening 314, whereas rear portion 302A is just about to leave ejection opening 314. Then, as shown in Figures 54 and 59, arm 318 is counter rotated about 180 and distal end 319 thereof engages notch 303 of needle 308, which has just entered withdrawal opening 314. Then, as shown in Figure 54A, arm 318 is rotated as before so as to complete a full cycle of needle 318. Since needle 318 is holding 4.4444suture 308, as a result of the motion of needle 302, suture 308 follows the .same circular path. Thus, as shown in figure 62, by appropriately 0 locating the suturing device described herein against a tissue 340, one 20 can, using the suturing device as describe, to suture the tissue as shown.

*4*e*As already mentioned above, and as shown in Figure 47, wall 306 can be a side wall of member 300, in which case the circular path taken by needle 302 is on a plane which substantially parallels a plane trvrigthe srensfinger from tpto boftom or lternatively a shown in Figure 48, wall 306 can be a front wall of member 300, in which case the circular path taken by needle 302 is on a plane which is substantially perpendicular to the longitudinal axis of the surgeon's finger. In yet another configuration, the circular path taken by needle WO 01/12094 WO 0112084PCT/nM/0IO439 26 302 is on a plane which substantially parallels a plane traversing the surgeon's finger from side to side.

As specifically shown in Figure 61, according to a preferred embodiment of this aspect of the present invention the suturing device further includes a reporting mechanism 350 for reporting situations, such as, but not limited to, a full ejection of substantially semi-circular surgical needle' 302, a full withdrawal of substantially semi-circular surgical needle 302, a degree of ejection of substantially semi-circular surgical needle 302 and a degree of withdrawal of substantially semi-circular surgical needle 302. Reporting mechanism 350 according to a preferred embodiment includes two or more terminals 352 (Figures 49 and 6 1) located along the ejection/withdrawal path and which form a part of a circuit 353 which includes a power source 354 and a ligh~t and/or sound indicator 356 (Figure 61), both are preferably located within a housing also houses actuator 336 (Figure 60). In the example shown in Figure 61, when front portion of needle 302 enters withdrawal opening 314 between contacts 352, circuit 353 closes and indicator 356 operates, thereby indicating full ejection of substantially semi-circular surgical :needle 302. It will be appreciated that by locating terminal at other locations along the path taken by needle 302 enables to similarly monitor a full. withdrawal of substantially semi-circular surgical needle 302, a dere ofeeto*fsbtnilysm-crua ugclnel 0 n degree of ejetionwa of substantially sei-circular surgical needle 302.d It will be appreciated that, in contrast with the suturing device of the first aspect of the invention, no finger movement is required to eject and/or withdraw needle 302. It will fuirther be appreciated that using actuator 336 and mechanism 350, one gains a high level of control and preciseness on the operation of the suturing device according to this aspect of the present invention.

WO 01/12084 PCT/IL0/00439 27 As shown in Figures 63-65 according to yet another aspect of the present invention there is provided a finger-guided, surgical instrument which serves as a sampling device for sampling a sample from a body location.

The sampling device includes a thimble-like element 400 which is adapted to surround at least a portion of a surgeon's finger, while at least partially exposing the ventral tactile portions of the distal phalanx thereof, so as to enable the surgeon to tactile sense a body location to be sampled.

According to a preferred embodiment thimble-like element 400 is constructed so as to be mounted over a ventral side of the distal phalanx of the surgeon's finger, thereby exposing the tip of the ventral tactile portion of the distal phalanx, underneath the nail.

The device further includes an ejectable capillary 402 which is engaged within a housing 404 formed in a wall, back wall 406, of thimble-like element 400. The device further includes a first mechanism 408 for ejecting ejectable capillary 402 from thimble-like element 400, so as to enable the surgeon to capillary sample the body location. Ejectable capillary 402 is preferably a translatably ejectable capillary, whereas first mechanism 408 is a remotely operated translatable ejection mechanism, having an ejection relay 409 operated via a translating actuator 420, and which propagates along a tube 422 to translate capillary 402. Capillary 402 is ejectable in a direction generally in extension of a longitudinal axis of thimble like element 400.

25 According to a preferred embodiment of this aspect of the present invention the sampling device further includes a translatably ejectable sleeve 410 which is engaged within housing 404 and surrounds ejectable capillary and a second mechanism 412 including a translation relay 413 for ejecting translatably ejectable sleeve 410 from thimble-like element WO 01/12084 WO 0112084PCT(1L0000439 28 400, so as to shield the sampled body location from surrounding body fluids while sampling. Sleeve 410 is ejectable in a direction. generally in extension of a longitudinal axis of thimble like element 400.

According to another preferred embodiment of the sampling device according to this aspect of the present invention, the sampling device further includes an ejectable puncturing device 414 which is engaged within housing 404, wherein first mechanism 408 further serves for ejecting ejectable puncturing device 414 from thimble-like element 400, so as to enable the surgeon to wound the body location to be I0 sampled. Device 414 is ejectable in a direction generally in extension of a longitudinal axis of thimble like element 400.

According to an alternative embodiment of the sampling device according to this aspect of the present invention, and as specifically shown in Figure 66, ejectable capillary 402 has sharp edges 416 so as to enable the surgeon to wound the body location, thereby obviating the need for puncturing device 414. In this case, ejectable capillary 402 is preferably a rotatably-translatably ejectable capillary, whereas first' mechanism 408 is a remotely operated rotatable-translatable ejection mechanism (Figure 65, shown as thread 411), having an ejection relay 409 operated via a rotating-translating actuator 421, and which rotatably propagates along tube 422 to rotatably translate capillary 402.

According to another preferred embodiment, ejectable capillary 302 is an ejectable aspiration capillary, whereas the sampling device further includes a remote aspirating device, such as a syringe 430, which 25 is in fluid communication with ejectable aspiration capillary via a tube 433 which also serves as relay 409 is employed to aspirate a sample into capillary 402, thereby obviating the need to depend on capillary action for sample collection, enabling the collection of larger volumes in a single sampling session.

WO 01112084 WO 0112084PCTILOIOO0439 29 It will be appreciated that mechanisms 408 and 412 can be used to withdraw their respective tools, prior to the removal of the sampling device from the sampled body location, if so required, in order not to risk injuring the patient doing so.

According to a preferred embodiment of this aspect of the present invention the sampling device further includes a reporting mechanism 440 for reporting a situation, such as, but not limited to, a full ejection of capillary 402, sleeve 410 and/or device 414, a full withdrawal of capillary 402, sleeve -410 and/or device 414,, a degree of ejection of capillary 402, sleeve 410 and/or device 414 and a degree of withdrawal of capillary 402, sleeve 410 and/or device 414. Reporting mechanism 440 operates in a fashion similar to mechanism 350 described hereinabove with respect to Figure 61, whereby capillary 402, sleeve 410 and/or device 414 are conductive and the presence of portions thereof is determined by closing is or opening an electrical circuit so as to activate or deactivate an indicator :457 (Figure As specifically shown in Figure 66, according to another preferred embodiment of this aspect of the present invention the sampling device further includes a reporting mechanism 460 in capillary 402 for reporting to the surgeon of a situation, such as, but not limited to, a presence of fluid in capillary 402 and a level of fluid in capillary 402. Since body fluids are conductive, such fluids serve to close circuit 462 by engaging a ****.space between terminals 464, so as to enable a power source 466 to power an indicator 468.

25 As shown in Figures 68-74, according to still another aspect of the present invention there is provided yet another finger-guided surgical instrument which serves as an anchor implanting device. The anchor implanting device comprising a thimble-like element 500 which is adapted to surround at least a portion of a surgeon's finger while at least WO 01/12084 PCT/ILOO/00439 partially exposing the ventral tactile portions of the distal phalanx thereof, so as to enable the surgeon to tactile sense a body location into which anchor or a pair of anchors are to be implanted. Thimble-like element 500 is preferably constructed so as to be mounted over a dorsal side of the distal phalanx of the surgeon's finger, thereby exposing the entire ventral tactile portions of the distal phalanx.

The device further includes at least one ejectable anchor guiding element 502 which is engaged within at least one housing 504 which is formed within, or connected to, at least one wall, preferably side walls 0o 506 of thimble-like element 500. The device further includes at least one first mechanism 508 for ejecting anchor guiding element(s) 504 from thimble-like element 500, so as to penetrate or come closer to a body location. The device further includes at least one ejectable anchor 510 engaged within ejectable anchor guiding element(s) 502, a cord 507 is connected thereto at a position so as to effect rotation and therefore efficient anchorage of anchor(s) 510 when anchored in the body location by pulling on cord 507. The device further includes at least one second mechanism 512 which serves for ejecting ejectable anchor(s) 510 from within ejectable anchor guiding element(s) 502, so as to enable the surgeon to anchor ejectable anchor(s) 510 in the body location.

:According to a preferred embodiment of the present invention first mechanism(s) 508 include at least one remotely operated rotating arm .514 which is engaged in hosing 504 and which is rotatable about a hinge 516. Arm(s) 514 are designed to eject ejectable anchor guiding S 25 element(s) 502 through at least one ejection opening 516 formed in housing(s) 504 by pushing rear portion(s) 518 of ejectable anchor guiding element(s) 502. According to a preferred embodiment, remotely operated rotating arm(s) 514 are further designed to withdraw ejectable anchor guiding element(s) 502 by pulling rear portion(s) 518 of ejectable anchor WO 01/12084 PCrI/LOO/00439 31 guiding element(s) in a reverse direction. According to a preferred embodiment arm(s) 514 are rotated by a shared remote rotation actuator 520 which rotates relay(s) 522 which pass through a tube 524 and surrounds rotating wheel(s) of arm(s) 514.

Second mechanism(s) 512 include at least one remotely operated translatable ejection mechanism 530 which serves for ejecting anchor(s) 510 from ejectable anchor guiding element(s) 502. Mechanism(s) 530 are operated via a translation actuator 532 and a translation relay 534 passing through tube 524.

Closed-open circuitries are preferably employed as a reporting mechanism for reporting a situation, such as but not limited to a full ejection of the at least one ejectable anchor, a full ejection of the at least one ejectable anchor guiding element, a full withdrawal of the at least one ejectable anchor guiding element, a degree of ejection of the at least S. 15 one ejectable anchor guiding element and a degree of withdrawal of the at least one ejectable anchor guiding element. The operation of such circuitries are further described herein above with respect to other aspects of the present invention.

Thus, as shown in Figure 74, by first ejecting guiding elements 502 and then ejecting anchor(s) 510, the surgeon can anchor anchor(s) 510 is a tissue 560. By pulling cord 507, the surgeon tilt's an anchor 507 so as to be strongly engaged within tissue 560.

SThe devices described hereinabove enjoy several advantages over prior art designs. All of the devices described include a thimble-like element which is designed to enable tactile sensing by a wearing finger.

All of the devices include an ejectable surgical tool, which is withdrawn in a housing of the device and which is ejected only upon use. Thus, the devices according to the present invention allow the surgeon to sense a body location to be operated or treated while approaching the location WO 01/12084 WO 0112084PCT/LOOOO439 32 without the disturbance of a permanently protruding surgical tool, tactile sense the location, and then, at the appropriate location, eject the tool to operate or treat the patient. In some embodiments, the ejection process is by a ratchet mechanism operated by rotating the surgeon's finger, whereas in other embodiments remote translation or rotation actuators are employed, which actuators are operable by the free hand of the surgeon.

The following sections describe some preferred embodiments, one or more of which can be applied to any of the devices of the preset invention. Some of these embodiments have already been described with respect to some of the described devices, but not others and are therefore repeated herein in a more generalized form.

Thus, as shown in Figures 75 and 76, according to a preferred embodiment of the present invention, and in order to fit a plurality of fingers of a single surgeon, or in order to fit a single finger, such as the pointing finger, of a plurality of surgeons having fingers in a variety of thicknesses, the finger-mounted device for guiding a surgical instrument and/or the finger-guided surgical instrument according to the present invention further includes an adapter 600 which is insertable between the thimble-like element and the surgeon's finger, so as to adapt the finger- 20 mounted device or the guided surgical instrument to fingers of different sizes.

As shown in Figure 63, according to another preferred embodiments of the present invention any of the finger-mounted devices 0* for guiding a surgical instrument and/or the finger-guided surgical instruments according to the present invention can include a supporting strap 602, for firmly mounting andl supporting the device or instrument onto the surgeon's finger.

In preferred embodiments of the present invention the mechanism -which is employed to eject a surgical tool out of the housing of the thimble-like element includes a first portion engaged within the housing WO 01/12084 PCT/EOOOO439 33 and which is in contact with the ejectable surgical tool and a second, remote, portion extending out of the patients body and which includes an actuator operable by a free band of the surgeon, so as to eject the surgical tool from the thimble-like element. Alternatively, the mechanism includes a ratchet member disposed between the thimble-like element and the surgeon's finger, so as to eject the surgical tool from the thimble-like element by twisting back and forth the surgeon's finger. Any such mechanism is shown herein to also function for withdrawing the ejectable surgical tool back into the housing. Depending on the specific l0 application, any one or more walls of the thimble like element can include a housing for engaging the ejectable surgical tool and at least a portion of the mechanism employed for its ej ection. Thus, side, front and back walls can be used accordingly.

The thimble-like element employed in any of the aspects according to the present invention can be constructed so as to be mounted :over a dorsal side of the distal phalanx of the surgeon's finger, thereby exposing the entire ventral tactile portions of the distal phalanx.

Alternatively, the thimble-like element is constructed so as to fully surround the distal phalanx. and expose the tip of the ventral tactile portion of the distal phalanx, just underneath the nail. Yet, alternatively, the thimble-like element is constructed so as to be mounted over a ventral side of the distal phalanx of the surgeon's finger and expose the tip of the ventral tactile portion of the distal phalanx. In some embodiments of the present invention the surgical tool is ejectable in a direction generally in 25 extension of a longitudinal axis of the thimble like element. However, in other embodiments, the surgical tool is ejectable in a circular path which can be on a plane which substantially parallels a plane traversing the surgeon's finger from top to bottom, on a plane which substantially parallels a plane traversing the surgeon's finger from side to side, or on a WO 01/12084 PCT/IL00/00439 34 plane which is substantially perpendicular to the longitudinal axis of the surgeon's finger.

Throughout the specification examples have been given to the use of any one of a plurality of ejectable surgical tools in context of the finger-mounted device or surgical instrument of the present invention.

Thus, a surgical needle, a needle carrying a surgical anchor ejectable therefrom, a puncturing device, an injection needle, a capillary, a puncturing capillary, a miniaturized surgical grasper, miniaturized surgical scissors, a miniaturized blade and/or an aspiration capillary can to all be either guided via the finger mounted device and/or ejectably and operatively engaged with the finger guided surgical tool according to the present invention.

According to preferred embodiments, the finger-mounted device for guiding a surgical instrument and/or the finger-guided surgical 15 instrument include a reporting mechanism for reporting at least one situation selected from the group consisting of a full ejection of the surgical tool, a full withdrawal of the surgical tool, a degree of ejection of the surgical tool and a degree of withdrawal of the surgical tool.

As shown, for example, in Figures 34, 35, 47, 48, 63, 64 and 68, 20 according to a preferred embodiment of the present invention the fingermounted device and/or the finger-guided surgical instrument further includes at least one optical head 700 engaged by the thimble-like element thereof. Optical head 700 communicates with a monitor or any other display for presenting the surgeon with details of the path to the S 25 body location to be treated or the treated body location itself prior, during or after treatment. Optical head 700 can include a miniaturized camera and/or preferably a bundle of optic-fibers to generate an image which is representable on a monitor or any other display. In addition, optical head 700 can include one or more optical elements such as, but not limited to, lenses, prisms, reflectors and the like. Of particular interest is a fish-eye WO 01/12084 PCTJLO/00439 lens which can be used to provide a larger field of view for optical head 700.

According to a preferred embodiment of the present invention,, optical head 700 includes a lens for focusing imagery data onto a boundle s of fiber optics which transmit the imagery data to a sensor, such as, but not limited to, a camera which is remote and connectable to the device or instrument. This feature is of importance in cases the device or instrument are of a disposal type.

The following sections relate to the use of the finger-guided io surgical instruments herein described in various surgical procedures. It is understood that these procedures are provided as examples and are not to be taken as limiting. It will be appreciated by one of skills in the art that many other procedures can be performned using the instruments of the present invention. More particularly, the following exemplary surgical procedures describe surgical protocols in which a single finger of a surgeon is inserted intrabodily and is employed to tactile sense a body location to be treated. However, it will be appreciated that the instruments of the present invention may fid uses in other extra or intrabody surgical procedures.

While the suturing devices according to the invention will be described and explained herein as being applied in a novel procedure for bladder-neck suspension used for treatment of urinary incontinence (genuine stress urinary incontinence GSUI) in females, it is also suitable for application in, sacro-spinous ligament fixation, and for anchoring suture material, even in conventional transabdonunal pelvic surgery, where in obese patients exposure is limited and the surgeon has to rely on palpation of pelvic structures.

TFhe procedure is a surgical treatment. of genuine stress urinary incontinence in- females, and aims at the correction of the suspension of the anatomidcal area defined as the "bladder neck", i.e., WO 01/12084 WO 0112084PCT11L0000439 36 returning the bladder neck to its former, normal position. Such procedures are known, the one having the highest success rate being the Burch Colposuspension, in which the pelvic fascia and vaginal wall lateral to the urethra is suspended to Cooper's ligament. While this procedure indeed appears to be the most promising, it still is a transabdominal method, requiring general anesthesia, an extensive abdominal incision and hospitalization.

While the procedure facilitated by the present invention follows the same anatomical principles as the above-mentioned Burch method, it is,- in contradistinction thereto, a transvaginal, rather than a transabdominal, bilateral suspension of the bladder neck to Cooper's ligament It is this distinction which turns the treatment, as a matter of fact, into an office, outpatient procedure.

The anchor implanting device described herein can be employed, 15 for example, in an orthopedic procedure known as open Bankart shoulder stabilization.

Recurrent shoulder dislocations are relatively common. In an Israeli epidemiological study (Milgrom et al., Journal of Shoulder and Elbow, Nov. 1998) it was found that 0.05 of soldiers between the ages 20 of 17 and 33 suffer from this problem. The more a population is exposed to trauma or sports the higher the likelihood of dislocations. A shoulder ::dislocation in an elderly persor- however does not usually result in recurrent dislocations. Traumnatic recurrent shoulder dislocation is usually treated by surgery. In the vast majority of cases, the essential 25 lesion causing the recurrent shoulder instabilit--. is a tear of the anteriorinferior or anterior-medial labriumn from the glenoid rim. This lesion needs to be repaired so that dislocation can be prevented. The procedure is done under general anesthesia, in a beach chair position. Usually three surgeons a-eqir e f or executing the procedure. One to retract soft 30 tissue, and two to perform the surgery. The advent of bone suture WO 01/12084 WO 0112084PCTILOOIO439 37 anchors has made the suture of the labrium back to bone simpler. There is however still considerable difficulty in- passing the sutures that are attached to the bone suture anchors implanted in the glenoid rim from underneath the labriumn to the labrial superior surface in a very tight anatomical space. Because of this small space, performing the twisting motion of the needle to pass it through the tissue in an exact way is difficult. Typical to this repair of the labrium, 1-3 suture anchors are used and therefore 3 sutures have to be passed. The entrance of the suture at the proper site is very important because the labrium must be returned to its precise anatomical position to ensure a proper repair that will prevent recurrent dislocations. This task is readily performed using the figer-guided anchor implant device of the present invention. It also allows the surgery to be conformably performed with a team of only two surgeons.

15 The sampling device according to the present invention can be **:employed as a scalp pH device.

Part of the contemporary management of labor includes evaluation **of the fetal well being. This is done by fetal heart monitoring and measurement of fetal blood pH and gases. Fetal heart monitoring is 20 performed by recording the electrical activity of the fetal heart and displaying it as a graph of the fetal heart rate at any time. The fetal blood gases and pH are measured by sampling the fetal blood through the open ****cervix. The procedure is performed in order to confirm a suspicions of fetal distress that will jeopardize the fetal well being unless treated 25 immediately by delivery of the fetus. Presently, fetal scalp blood sampling can be performed only if the membranes has rapture and the cervix is open enough to allow the introduction of a cone shaped plastic tube with a diameter of 3-4 cm through the vagina and into the cervix.

The tube is applied to the fetal scalp in direct contact. The obstetrician scratches the scalp skin using a sharp object through the tube and collects WO 01/12094 WO 0112084PCrfILOOoo439 38 the drop of blood at the site of the scratch. The blood is taken for analysis.

The sampling device of the present invention allows the obstetrician to perform the same procedure in an easier and patient friendly fashion using his finger only. The device will eliminate the need to place the patient in dorsolithotomy position and suffer the discomfort of the large tube applied into her vagina. Mounting a small device that performs blood sampling over the obstetrician's finger enables to sample feral scalp blood in an earlier stage of labor, in which the cervix opening is smaller, because the obstetricians finger diameter is smaller then the tube diameter.

In cases of Rectal Prolapse, which is a known complication of Cystic Fibrosis, the surgical correction can be perform by constriction of the anal opening which might cause chronic defecation dysfunction or through an abdominal approach. In the transabdominal procedure the :upper part of the rectum is anchored to the Sacral bone. Using any of the suturing devices of the present invention can render the anchoring procedure in the small and deep pelvic area an easier and shorter process, avoiding the need of extensive dissection to expose the correct anatomical target Another procedure that will benefit from the use of the suturing devices of the present invention is in the case of treating Esophageal reflux in children. The surgical correction is based on reconstruction of a *.one way valve mechanism around the Esophagus. Passing a 'Vessel 25 loop", a thin rubber band, around the Esophagus prevents the reflux.

Any of the suturing devices of the present invention can replace the need for dissection of the Esophagus and makes it easy to pass the Vessel loop behind the esophagus in a short and safe fashion.

Norma!l vaginal dilivery expose the female pelvic floor to muscle and connective tissue trauma which is some cases results in pelvic floor WO 01/12084 PCTrIIO000439 39 relaxation and pelvic organ prolapse. Vaginal prolapse is a result of weakening of connective tissue support to the vaginal vault apex. One of the most common surgical techniques used to corret vaginal prolapse includes tying the upper part of the vagina to a connective tissue condensation stretched from both sides of the sacrum. T7his anatomical structure is called The Sacrospinous Ligament, and the procedure is called Sacrospinous Ligament Fixation. In order to perform the procedure, the surgeon needs to open the posterior wall of the vagina and enter to a space beside the rectum to reach the ligament A surgical thread is anchored to the ligament and is thereafter tied to the vagina, thus fixing the upper part of the vagina to the ligament. Since the location of the ligament is deep in the pelvic hole, the surgeon needs to perform extensive dissection to expose the ligament and place the suture material under direct visualization using long instruments. However, 15 palpation of the ligament is easy and within reach of the surgeon's finger.

Mounting any of the suturing devices according to the present invention over the surgeon's finger thus enables the surgeon to place the suture in 0 the correct location, avoiding the need for extensive dissection, reduce blood lose and shorten operation time. Palpation of the correct location 20 makes the procedure even safer by reducing the risk of injury to pelvic blood vessels behind certain areas of the ligament.

1: .0 Rupture of the rectum in large animals, especially horses and 0000 0 cows, oftentimes happens during rectal examination when a peristaltic wave passes over the wrist of the examiner, or following insertion of a stallion's penis into the rectum. Usually a colostomy is done to bypass the rectum and then an attempt is made to suture the tear in the rectum at a distance of 30 to 40 cm from the anus. The suture is placed blindly by palpation of the tear and an attempt is made to place a suture using a needle held by the finger of the operator. Any of the suturing devices WO 01112084 PCTILOOOO439 according the present invention can be employed to *assist suturing the tear.

Injury to the cervix after foaling is a known complication. This leads to infertility because of loss of the fetus through the cervix 1 to 3 months after conception. The present treatment involves placement of sutures into the cervix after conception, so as to reduce the size of the opening. These sutures are inserted blindly by a needle held by the fingers. Any of the suturing devices according to the present invention can be used instead.

In cases of rupture of the uterus at parturition, often the tear is large and repair must be done by means of a laparotomy. However, small tears can be caused by the foot of the foal. Present treatment is effected by placing sutures in the uterus after parturition, to close the small openings and prevent rapture of the uterus in the next pregnancy.

0O 15 Presently, these sutures are placed blindly by a needle held by the fingers.

Any of the suturing devices according to the present invention can be used instead.

C. .Although the invention has been described in conjunction with 4. 20 specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art.

S Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

Claims

1. A finger-guided surgical instrument, comprising: a thimble-like element being adapted to surround at least a portion of a surgeon's finger while at least partially exposing the ventral tactile portions of the distal phalanx thereof, so as to enable the surgeon to tactile sense a body location to be treated; an ejectable surgical tool being engaged within a housing being formed within, or connected to, a wall of said thimble-like element; and a mechanism for ejecting said surgical tool from said thimble-like element, so as to enable the surgeon to operate said body location, said mechanism including a first portion engaged within said housing and which is in contact with said ejectable surgical tool, a second, remote, portion being adapted to extend out of the patient's body and a flexible cable in a tube o connecting said first portion to said second portion, said second remote portion being operable by a free hand of the surgeon so as to eject said surgical tool from said thimble-like element.

2. The finger-guided surgical instrument of claim 1, further comprising an adapter insertable between said thimble-like element and the surgeon's ""finger, so as to adapt the guided surgical instrument to fingers of different size.

The finger-guided surgical instrument of claim 1, wherein said mechanism further serves for withdrawing said ejectable surgical tool back into said housing.

4. The finger-guided surgical instrument of claim 1, wherein said wall is a side wall of said thimble-like element.

The finger-guided surgical instrument of claim 1, wherein said wall is a front wall of said thimble-like element. 42

6. The finger-guided surgical instrument of claim 1, wherein said thimble-like element is constructed so as to be mounted over a dorsal side of the distal phalanx of the surgeon's finger, thereby exposing the entire ventral tactile portions of the distal phalanx.

7. The finger-guided surgical instrument of claim 1, wherein said thimble-like element is constructed so as to fully surround the distal phalanx and expose the tip of the ventral tactile portion of the distal phalanx.

8. The finger-guided surgical instrument of claim 1, wherein said thimble-like element is constructed so as to be mounted over a ventral side of the distal phalanx of the surgeon's finger and expose the tip of the ventral tactile portion of the distal phalanx.

9. The finger-guided surgical instrument of claim 1, wherein said surgical tool is ejectable in a direction generally in extension of a longitudinal axis of said thimble-like element.

The finger-guided surgical instrument of claim 1, wherein said surgical tool is ejectable in a circular path.

11. The finger-guided surgical instrument of claim 10, wherein said circular path on a plane which substantially parallels a plane traversing the o surgeon's finger from top to bottom.

12. The finger-guided surgical instrument of claim 10, wherein said o circular path on a plane which substantially parallels a plane traversing the surgeon's finger from side to side.

13. The finger-guided surgical instrument of claim 10, wherein said circular path on a plane which is substantially perpendicular to the longitudinal axis of the surgeon's finger.

14. The finger-guided surgical instrument of claim 1, wherein said surgical tool is selected from the group consisting of a surgical needle, a needle carrying a surgical anchor ejectable therefrom, a puncturing device, an 43 injection needle, a capillary, a puncturing capillary, a miniaturized surgical grasper, miniaturized surgical scissors, a miniaturized blade and an aspiration capillary.

The finger-guided surgical instrument of claim 1, further comprising a reporting mechanism for reporting at least one situation selected from the group consisting of a full ejection of said surgical tool, a full withdrawal of said surgical tool, a degree of ejection of said surgical tool and a degree of withdrawal of said surgical tool.

16. The finger-guided surgical instrument of claim 1, further comprising an optical head engaged by said thimble like element.

17. A finger-guided surgical instrument, comprising: a thimble-like element being adapted to surround at least a portion of a surgeon's finger while at least partially exposing the ventral tactile portions of :Oo the distal phalanx thereof, so as to enable the surgeon to tactile sense a body location to be treated; an ejectable surgical tool being engaged within a housing being formed within, or connected to, a rigid wall of said thimble-like element; and a mechanism for ejecting said surgical tool from said thimble-like element, so as to enable the surgeon to operate said body location, said mechanism including a ratchet member being disposed between said thimble- like element and the surgeon's finger so as to eject said surgical tool from said thimble-like element by twisting back and forth the surgeon's finger. 0*-SSI

18. A finger-guided surgical instrument substantially as hereinbefore described with reference to the corresponding accompanying drawings.