WO1994005224A1

WO1994005224A1 - Surgical apparatus

Info

Publication number: WO1994005224A1
Application number: PCT/US1993/008127
Authority: WO
Inventors: Kenneth Kensey; Harold Clupper; John Nash; James J. Meikle, Jr.; Todd M. Dewitt; Herbert G. Kephart; James A. Walls
Original assignee: Kensey Nash Corporation
Priority date: 1992-08-27
Filing date: 1993-08-27
Publication date: 1994-03-17
Also published as: AU4840893A

Abstract

Instruments (200A, 510, 610, 600A, 800A) for performing medical procedures in an interior portion, e.g., an insufflated abdomen (10), of the body of a living being from outside the body of the being via a small percutaneous incision or puncture (16, 514, 614, 2140). The instruments each include a distal portion having a working head in the form of a pair of jaws (210, 212, 530, 532, 630, 632, 230A, 232A, 610, 612, 610', 612', 610A, 612A), whose free end is sufficiently blunt as to not pose a danger to tissue within the abdomen. An extendable/retractable piercing device (300, 400, 620, 200C, 400A, 500A, 7000, 1000) which either forms a portion of the instrument or is separate therefrom is mounted on the distal end of the instrument and arranged to be extended to pierce through the skin to enable the working head to be passed through the skin and underlying tissue into the abdomen without the use of a trocar or other introducing device. A flange (408A, 4080, 1004) is provided in some embodiments to control the depth of penetration of the device. The instruments also include a proximal portion (202, 604A, 606A) arranged to be held outside the body of the being when the working head is located at the desired position. The piercing device is retractable from the instrument so that it doesn't pose a danger to internally located tissue. The instrument's jaws are opened or closed by manipulation of the proximal portion of the instrument to perform the procedure. After that is done the instrument is removed from the percutaneous incision or puncture, whereupon it seals itself.

Description

SURGICAL APPARATUS

The invention relates generally to surgical instruments for performing medical procedures within the body of a patient via a small percutaneous incision or puncture and without requiring the use of a trocar to provide access Into the patient's body.

Various devices are commercially available for introduction through a trocar into the body of a being to effect some laparoscopic or endoscopic procedure. One typical type of device comprises grasper for grasping and positioning, e.g. reflecting, tissue within the patient's body. Such devices comprise an elongated body member having a distal end at which a pair of pivotable jaws are located and a proximal end at which a pair of pivotable actuating handles are located. The instrument is Inserted within the patient's body through a conventional trocar until the pivotable jaws are located adjacent the tissue to be clamped. The actuating handles are then squeezed together to cause the jaws, which are coupled thereto, to grasp the tissue. Other types of trocar introduced devices used heretofore are staplers biopsy devices, electrocautery devices, suturers, etc. The patent literature Includes various devices for to effect some laparoscopic, endoscopic, arthroscopic, or other minimally Invasive procedure e.g., United States Letters Patent Nos. 4,662,371 (Whipple et al.); 4,763,669 (Jaeger), 4,872,456 (Hasson) ; 4,917,100 (Nottke) ; and 4,963,147 (Agee et al.).

Other medical instruments utilising jaws or cutting blades are shown in United States Letters Patent Nos. 984,756 (Frisch) ; 1,659,112 (Littlejohn) ; and 4,877,026 (Laforcade) .

While the prior art devices may be suitable for their intended purposes they nevertheless leave much to be desired from various standpoints. For example, instruments requiring the use of a trocar for percutaneous introduction typically require that the incision or puncture be sutured after the trocar has been removed. Obviously, this action is time consuming,

SUBSTITUTESHEET relatively expensive, and wasteful of personnel resources. Moreover, the making of the incision or puncture sufficiently large for a conventional trocar is somewhat traumatic for the patient, particularly if multiple incisions or punctures are required to effect the percutaneous procedure.

Thus, the need exists for instruments for effecting medical procedures via very small percutaneous incisions or punctures, to expedite the procedure, conserve medical resources and minimise trauma to the patient and to eliminate the need for- suturing. The invention aims to provide such instruments having piercing means to form the required incision which are designed so as not to prevent risk of damage to internal organs or tissue when the instrument pierces through the incision to the interior of the body and to provide such instrument and method of accomplishing medical procedures which instrument is sufficiently small that the incision it forms heals itself after removal of the instrument.

The invention, therefore, provides instruments as defined in the appended Claims.

Thus the invention provides an instrument for performing some medical procedure in the body of a being, which instrument has a proximal portion, a distal portion, working means and, usually, coupling means with the distal portion comprising piercing means. Usually, of course, there will be an intermediate portion between the proximal and distal portions. The intermediate portion will usually be elongated and have a longitudinal axis. The distal portion may be considered to comprise a continuation of the intermediate portion and hence also have an elongated portion with a longitudinal axis together with the working and piercing means which will be arranged at the distal end.

The piercing means is arranged for forming a small percutaneous incision or puncture in the body of the being to enable the

SUBSTITUTESHEET distal portion of the instrument to be inserted into the body of the being to a desired internal position without the use of a trocar or other introducing means while the proximal portion remains located outside the body.The incision or puncture which is formed by the piercing means is sufficiently small that it is self-sealing after said distal portion of the instrument has been removed from it.

In one embodiment the piercing means is movable from its piercing configuration to a safety configuration after making the incision.

In another embodiment the piercing means has a tip that is shaped to be insertable through skin and tissue under pressure but is sufficiently blunt not to present a cutting hazard to tissue and organs within the body.

In a further embodiment the piercing means are tissue penetrating means comprising a small diameter elongated member having a first pointed tip arranged to be moved to an extended position where it is exposed so that it may pierce the skin to form a small nick therethrough and engagement means comprising a second tip having a surface to engage and be extended through the nick and through the underlying tissue upon the application of force to the apparatus, the surface of the second tip being sufficiently blunt not to present a hazard to tissue or organs.

As indicated above, the distal portion of the instrument may be elongated and have a longitudinal axis and in one embodiment comprises working means arranged to project outward laterally of the longitudinal axis for engagement with tissue located at the desired position, e.g. operative site, to perform some operation on that tissue when the working means is actuated.

In accordance with the teachings of this invention the working means may comprise any type of instrument to perform some procedure on internal tissue or internal structure(s) . In

SUBSTITUTESHEET preferred embodiments shown and described herein that comprises a pair of moveable jaws to enable one to clamp tissue therebetween for positioning that tissue. Some embodiments may, if desired, make use of a moveable piercing tip. In particular, in accordance with other preferred embodiments of the invention the piercing tip may either be pivotable with respect to the distal portion of the instrument in order to assume a retracted, e.g safety, position after it has been used to form the percutaneous incision or puncture or may be removable from the distal portion of the instrument after it had been used to form the percutaneous incision or puncture so that it can be located in a retracted, e .g. safety position.

The invention is now further described with reference to the accompanying drawings wherein:

Figure 1 is a side elevational view, partially in section, of the distal portion of one embodiment of the invention shown with its piercing tip in position to effect its placement within the body of a patient;

Figure 2 is an exploded side elevational view, partially in section, of this embodiment;

Figure 3 is a side elevational view, partially in section, showing the apparatus of Figures 1 and 2 after its piercing tip has been removed and with its jaws grasping and reflecting internal tissue;

Figure 4 is an enlarged longitudinal sectional view of the distal end of another embodiment of the invention and showing its piercing tip extended;

Figure 5 is a view similar to Figure 4 showing the instrument with its piercing tip retracted;

SUBSTITUTE SHEET Figure 6 is a sectional view taken along lines 6 - 6 of Figure

5;

Figure 7 is a longitudinal sectional view of the distal part of another embodiment of the invention;

Figures 8-12 are illustrations showing the sequence of use of the instrument of Figure 7 for effecting the reflection of a lobe of the liver to expose the gall bladder;

Figures 13 and 14 are illustrations, similar to that of Figures 8 - 12, but showing two preparatory steps for accomplishing use of the instrument of this embodiment;

Figure 15 is a longitudinal sectional view of the distal portion of a further instrument of the invention;

Figure 16 is an enlarged isometric view of one of the jaws forming the distal end of the instrument of Figure IS;

Figure 17 is an enlarged isometric view of the piercing means portion of the instructions of Figure 15;

Figures 18 to 20 are illustrations showing the sequences of use of the instrument of Fig. 15;

Figures 21 to 23 are illustrations showing a sequence of use of the instrument of Figure 15 for placing a guide wire through the percutaneous incision, removing that instrument from the incision or puncture leaving the guide wire in place, and then using that guide wire to guide another instrument through the percutaneous incision or puncture into the interior portion of the being's body;

Figure 24 is a longitudinal sectional view of the distal end of another alternative embodiment of an instrument constructed in accordance with this invention;

SUBSTITUTESHEET Figure 25 is an enlarged sectional view taken along line 25 - 25 of Figure 24;

Figure 26 is an enlarged isometric view of a piercing device forming the piercing means portion of the instrument shown in Figure 24;

Figures 27 - 32 are illustrations showing the sequence of use of the instrument of Figure 24 for effecting the reflection of a lobe of the liver to expose the gall bladder;

Figure 33 is an isometric view of an alternative embodiment of the piercing device shown in Figure 26;

Figure^'34 is an end view of the device shown in Figure 33 taken long line 34 - 34;

Figure 35 is an enlarged illustration showing the use of the piercing device shown in Figure 33 on a conventional type of medical instrument for forming a percutaneous incision or puncture through the abdominal wall and without the use of a trocar;

Figure 36 is an isometric view of an alternative embodiment of the piercing device shown in Figure 33;

Figure 36A is a plan view of the opening in the skin and underlying tissue created by the devices shown in Figures 33 and 36;

Figure 37 is an illustration showing the use of the piercing device shown in Figure 36 on another type of medical instrument for forming a percutaneous incision or puncture through the abdominal wall and without the use of a trocar;

Figure 38 is an isometric view of an alternative embodiment of the piercing device shown in Figure 36;

SUBSTITUTESHEET Figure 38A is a plan view of the opening in the skin and underlying tissue created by the devices shown in Figure 38; and

Figure 39A is a side elevational view of the distal end of the device shown in Figure 38 along line 39 -39.

Figure 39 is a longitudinal sectional view of an alternative piercing device constructed in accordance with this invention shown supporting a conventional tissue grasping instrument therein;

Figure 40 is an isometric view of a locking bushing forming a portion of the device shown in Figure 39;

Figure 41 is a sectional view taken along line 41 - 41 of Figure 39;

Figure 42 is a sectional view taken along line 42 - 42 of Figure 39;

Figure 43 is an end view of the proximal end of the device shown in Figure 39; and

Figure 44 is an end view of the distal end of the device shown in Figure 39.

In Figures 1 and 2 there is shown an embodiment 200A of the instrument of this invention. That instrument is arranged to pierce through the skin and underlying tissue of a patient to locate a pair of jaws at some internal situs to effect the grasping of tissue thereat. The jaws are permanently oriented in the "extended" position. Notwithstanding that fact, the instrument 200A is capable of forming and being extended through a very small percutaneous incision or puncture 16 (Figure 1 to be formed by the instrument.

SUBSTITUTE SHEET Thus, as can be seen in Figure 2, the instrument 200A basically comprises housing or body portion 202 from which an elongated tubular sleeve assembly 204 extends. The sleeve assembly comprises an elongated sleeve 206, and an elongated rod or shaft 208 slidably mounted therein. The sleeve assembly 204 may be straight (as shown) or may be curved. In any case the distal end portion of the sleeve 206 includes an angularly oriented extension forming a jaw 210. In a similar manner the distal end portion of the shaft 208 includes an angularly oriented extension forming a jaw 212. The jaws are arranged to be slid with respect to each other parallel to the longitudinal axis 214 of the sleeve and rod so that then they can be opened and closed.

When the jaws 210 and 212 are completely closed, such as shown by the full lines in Figure 2 , they abut each other, whereupon the outer periphery of the conjoined jaws is substantially circular and of very small cross sectional area, e.g. the outside diameter of which is 0.109 inch (2.77mm) or less. It is in this configuration that the instrument 200A is used to pierce through the patient's skin and underlying tissue to locate its jaws 210 and 212 within the body of the patient at the desired situs (as will be described later) . The outside diameter of the sleeve assembly 204 is very small, e.g. 0.109 inch (2.77mm) or less.

Instrument 200A comprises a piercing tip whose details will be described later. Suffice it for now to state that the piercing tip can take various embodiments, two of which, are shown herein. They comprise a replaceable tip 300 of the instrument 200A and a pivotally extendable tip embodiment 400 of the instrument 200B (Figure 4) . In either embodiment the piercing tip includes at least one cutting edge at its distal end for piercing skin and underlying tissue to effect the percutaneous insertion of the sleeve assembly of the instrument 200A or 200B into the patient's body.

SUBSTITUTESHEET The instruments 200A and 200B are similar in construction, except for their piercing tips. Thus, only apparatus 200A will be described in detail hereinafter. To that end the body 202 of the instrument 200A basically comprises a hollow cylindrical housing 220 fixedly connected by a connector 222 to the proximal end of the sleeve 206. The housing 220 has a cylindrical interior cavity 226 In which a plunger assembly 228 is located. The plunger assembly is connected to the proximal end of the shaft 208 and serves as the means for sliding the shaft 208 within the sleeve 206 along axis 214 to effect the opening and closing of the jaws 210 and 212.

The plunger assembly 228 basically comprises a rod-like plunger element 230 having a distal end 232 at which the proximal end of the shaft 208 is fixedly secured. The outside diameter of the plunger element 230 is just slightly less than the inside diameter of the hollow interior 226 of the housing so that the plunger element can be slid longitudinally therethrough. The proximal end of the plunger element 230 is in the form of a cap or button 234 which extends through an opening 236 at the proximal end of the housing 220.

The housing 220 includes a pair of tabs 238 projecting perpendicular to the longitudinal axis 214 of the apparatus 200A. A helical compression spring 240 is located within the hollow interior 226 of the housing 220 interposed between the distal end 232 of the plunger element 230 and an annular recess 224 in the inner surface of the connector 222. The spring 240 surrounds the proximal portion of the shaft 208 and serves to bias the plunger element 230 toward the full line, position shown in Figure 2. In this orientation the jaws 210 and 212 of the instrument 200A are fully closed and, with the piercing tip 30 located thereon (as will be described later) , the instrument is arranged to form the percutaneous incision or puncture 16.

In order to centre the shaft 208 within the sleeve 206 and to facilitate its sliding action within the sleeve 206, a linear

SUBSTITUTE SHEET bushing 242 is located within a second annular recess 244 in the connector 222.

As can be seen in Figure 2, the jaw 210 comprises an angular extension of the distal end of the sleeve 206. The angular extension is slightly thicker than the thickness of the sleeve's sidewall and includes an inner surface 246 having a plurality of transversely extending serrations to form a good tissue grabbing surface. The jaw 212 comprises an extension of the shaft 208 and also includes a serrated inner surface 246.

The cross sectional profile of each of the jaws taken perpendicularly to their longitudinal axis 248 is generally hemispherical so that when the jaws are fully closed, i.e., when their serrated inner surfaces abut, the profile of the conjoined jaws 210 and 212 is circular and of very small cross sectional area, e.g., the outside diameter of which is 0.109 inch (2.77mm) or less.

A recess 250 is provided in the outer periphery of each of the jaws 210 and 212 very close to the distal end thereof. These recesses merge when the jaws 210 and 212 are fully closed to form an annular groove extending about the periphery of the conjoined jaws. The annular groove serves as the means for releasably securing the piercing tip 300 therein.

The piercing tip 300 basically comprises a member having a pyramidally shaped distal end 302 and a hollow proximal end 304. The hollow proximal end includes a cavity 306 formed by a peripheral sidewall of the tip. The lip of the sidewall has an inwardly directed bead 308 extending about the inner periphery thereof. The cavity 306 is arranged to accommodate the distal end of the instrument's closed jaws so that the bead 308 snap-fits into the annular groove formed by the recess 250 to releasably secure the piercing tip 300 onto the apparatus 200A. The pyramidal end 302 of the piercing tip 300 includes

SUBSTITUTE SHEfeτ four cutting edges 310 which merge together at the apex of the tip.

The operation of the apparatus 200A using the tip 300 to effect tissue reflection will now be described. The piercing tip 300 is mounted on the distal end of the instrument 200A as described above so that its cutting edges 310 are exposed. The surgeon then grasps the instrument 200A in one hand, with his/her thumb being disposed on the cap 234 and with his/her forefinger and index finger disposed on the respective extending tabs 238. The surgeon brings the tip 300 into engagement with the patient's skin located over the operative internal situs, e.g. the insufflated abdomen 10, and orients the instrument so that the conjoined angularly extending jaws are oriented in the desired direction, e.g. perpendicularly, with respect to the patient's body and then pushes that portion of the instrument inward. This action causes the sharp cutting edges 310 of the tip to cut through the skin 2, facia 4, muscle 6 and epithelium 8 to form a small percutaneous incision or puncture 16.

Once the conjoined angularly extending jaws are within the insufflated abdomen 10 the instrument is then oriented as shown in Figure 1 so the contiguous, longitudinally extending portion of the sleeve assembly 204 passes through the percutaneous incision or puncture 16. Continued inward pushing on the apparatus forces more of the sleeve assembly through the puncture 16 until the jaws are at ^' the desired internal position. This procedure can be monitored visually or electronically via any conventional means, e.g. a laparoscope.

The surgeon may then remove the tip 30 from the instrument 200A via some means (not shown) inserted into the patient's abdomen through another very small percutaneous incision or puncture. The removed tip 300 may be extracted from the body of the patient through that other percutaneous incision or puncture. If the tip is formed of a resorbable material, e.g •

SUBSTITUTESHEET polyglycolide, etc. it may be left in the body after it has been removed from the conjoined jaws 210 and 212.

In any event once the tip 300 has been removed the jaws 210 and 212 are freed so that instrument 200A is ready to be used to grasp adjacent tissue. To that end the surgeon applies thumb and finger pressure to the thumb cap 234 and finger tabs 238, respectively, to move the plunger element 230 further into the housing to the phantom line position shown in Figure 2. The movement of the plunger causes the concomitant movement of the shaft 208 within the sleeve 206 against the bias force produced by the compression spring 240. This action has the effect of moving the jaw 212 away from the jaw 210, thereby opening the jaws, whereupon internal tissue e.g. of liver 12, can be located therebetween.

In order to grasp that tissue the surgeon merely has to release the thumb pressure on the cap, whereupon the spring 240 carries the plunger element and the shaft 208 in the proximal direction until the jaws close on the interposed tissue. That tissue can then be held in position or reflected, as shown in Figure 3, depending upon the desires of the surgeon. Once the laparoscopic procedure has been accomplished, the surgeon may release the grasped tissue by again applying thumb pressure on the thumb cap 234 while his/her fingers hold the tabs 238. After the tissue is released the instrument 200A can be readily slid out of the percutaneous incision or puncture 16, so that the incision or puncture immediately closes and seals itself.

Attention will now be directed to Figure 4 wherein the details of the extendable piercing tip 400 of instrument 200B are shown. The tip 400 is permanently mounted on the distal end of the jaw 212. The tip 400 basically comprises a member having a planar surface forming a sharp cutting edge 402 at one end thereof and an arcuate surface 404 at the other end. The tip is located within a longitudinally extending slot 406 in the jaw 212. A pivot pin 408 extends through a pair of aligned

SUBSTITUTE SHEET holes 410 in the sidewalls forming the slot 406. The pin 408 extends through a hole 412 extending transversely through the tip 400. A helical spring 414 is disposed within the hole 412 and about the pivot pin 408. The spring 414 serves to bias the tip 400 to the retracted position shown in Figures 5 and 6, wherein the tip's cutting edge 402 is located within the slot 406. To accomplish that action one end 416 of the spring engages a portion of the jaw 212 immediately adjacent the slot 406 while the other end 418 of the spring 414 engages a portion of the interior of the tip 400.

In order to extend the tip 400 from its retracted position shown in Figures 5 and 6 to the extended position shown in Figure 4, so that the instrument 200B can be used to pierce through- the patient's skin and underlying tissue, the tip is pivoted against the bias of the spring about the pin 408 to bring its tip into axial alignment with the angularly extending jaw 212. The distal end of a stop rod 420 extending longitudinally through a passageway 422 in the jaw 212 is positioned to engage the arcuate surface 404 of the cutting tip 400 as shown in Figure 4. This holds the tip 400 in the extended position against the bias of the spring 414.

The instrument 200B may then be used to form the percutaneous puncture 16 in the same manner as described with respect to instrument 200A. When the distal end of the instrument 400B is within the insufflated abdomen, an actuator (not shown) forming a part of the instrument 200B and coupled to the stop rod 420 is operated by the surgeon to retract the stop rod away from tip 400. This action enables the spring 414 to rotate the tip 400 in the clockwise direction shown in Figure 5 so that its cutting edge 402 enters within the slot 406. The stop rod 420 can then be extended slightly distally to overlie the tip's cutting edge as shown in Figure 5, thereby insuring that the cutting tip is locked in the retracted position within the slot in jaw 212. The instrument 200B can then be used as described with reference to the instrument 200A.

SUBSTITUTE SHEET Referring now to Figures 7 to 14, another embodiment of the invention is shown in which the distal portion of the instrument 510 comprises a pair of jaws 530, 532 which conjoin so that the surfaces of their distal free ends together form a tissue engagement surface in the form of a piercing tip 520. The piercing tip 520 is arranged to pierce through the skin and underlying tissue to form the percutaneous incision or puncture. The jaws extend outward of the longitudinal axis of the instrument for grasping adjacent internal tissue, yet do not interfere with the passage of the elongated portion of the instrument through the percutaneous incision or puncture to the operative situs.

In the illustrations of Figs 8 to 14 there is shown the distal end of the instrument 510 when it is used to reflect a lobe of a patient's liver 512 (Figure 12) via a percutaneous incision or puncture 514 extending through the skin 516 and underlying tissue 518. In order to expedite the instrument's passage through the skin 516 and underlying tissue 518 to form the small percutaneous incision or puncture 514, such tissue should be supported internally as previously described.

Referring now to Figure 7, the instrument 510, basically comprises a proximal portion (not shown but having a housing or body portion similar to that of Figure 2) from which intermediate portion in the form of an elongated tubular sleeve assembly 524 extends. The sleeve assembly comprises an elongated sleeve 526, and an elongated rod or shaft 528 slidably mounted therein. The sleeve assembly 524 may be straight (as shown) or may be curved. In any case the distal end portion of the sleeve 526 includes an angularly oriented extension forming a jaw 530. In a similar manner the distal end portion of the shaft 528 includes an angularly oriented extension forming a jaw 532. The jaws make up the instrument's working means and are arranged to be slid with respect to each other parallel to the longitudinal axis 534 of the sleeve and rod so that they then can be opened and closed.

SUBSTITUTESHEET When the jaws 530 and 532 are completely closed, such as shown by the full lines in Figure 7, they abut each other, whereupon the outer periphery of the conjoined jaws is substantially circular and of very small cross sectional area. Moreover the distal end of each jaw is somewhat rounded, so that when the jaws are conjoined they form the heretofore identified piercing tip 520. It is in the conjoined jaw configuration that the apparatus 510 is used to pierce through the patient's skin 516 and underlying tissue 518 to locate its jaws 530 and 532 within the body of the patient at the desired situs (as will be described later) .

In accordance with this embodiment of the invention the rounded surface of the tip 520 is sufficiently pointed or tapering that it can pass through the skin 516 and underlying internally supported tissue 518 upon the application of a manual force by the surgeon to the instrument, yet is sufficiently blunt that it will not pose a hazard to internally located tissue, e.g., tissue within the insufflated abdomen.

A plunger assembly (not shown but similar to that of Figure 2) is connected to the proximal end of the shaft 528 and serves as the means for sliding the shaft 528 within the sleeve 526 along axis 534 to effect the opening and closing of the jaws 530 and 532.

As indicated the jaw 530 comprises an angular extension of the distal end of the sleeve 526. The ' angular extension is slightly thicker than the thickness of the sleeve's sidewall and includes an inner surface 566 having a plurality of transversely extending serrations to form a good tissue grabbing surface. The jaw 532 comprises an extension of the shaft 528 and also includes a serrated inner surface 566.

The cross sectional profile of each of the jaws taken perpendicularly to their longitudinal axis 568 is generally semicircular so that when the jaws are fully closed, i.e. when

SUBSTITUTE SHEET their serrated inner surfaces 566 abut, the profile of the conjoined jaw 530 and 532 is circular and of very small cross sectional area, while the conjoined free distal end surfaces of the jaws form the heretofore described tapered or rounded piercing tip 520.

The operation of the instrument 510 to effect reflection of some internally located tissue, e.g. a lobe of the liver 512, is shown in Figures 8 to 12. It is very similar to that described with reference to Figures 1 and 2 except that tip 520. is sufficiently shaped to penetrate skin and tissue without need of the separate tip 300. To accomplish that operation the skin 516 and underlying tissue 518 of the patient's abdomen and which are located over the patient's liver 512 is preferably insufflated with any suitable gas. Once this has been accomplished the surgeon grasps the instrument 510 in one hand and thus the tip 520 is brought into engagement with the patient's skin 516. The surgeon then pushes on the instrument so that it is directed inward, i.e. towards the patient's abdomen. This action causes the piercing tip 520 to pierce into and through the skin and the underlying tissue, as shown by the phantom lines in Figure 8 and the solid lines in Figure 9, until the tip 520 enters into the abdomen, as shown in Figure 10, whereupon a small percutaneous incision or puncture 514 is formed.

Once the conjoined angularly extending jaws are fully within the insufflated abdomen the instrument 510 is then oriented as shown in Figure 11 so that the contiguous longitudinally extending portion of the sleeve assembly 524 passes into the percutaneous incision or puncture 514. Continued inward pushing on the instrument forces more of the sleeve assembly through the puncture 514 until the conjoined jaws 530 and 532 are at the desired internal position.

Once the jaws 530 and 532 are free of the percutaneous incision or puncture, i.e. are within the abdomen, and adjacent the

SUBSTITUTE SHEET tissue to be reflected, they may be opened to grasp that tissue 512 therebetween.

In some cases in order to expedite the formation of the percutaneous incision or puncture 514, e.g., if the instrument does not include a tip which is suitable for piercing through the skin by itself without the application of undue force, the surgeon may utilize a conventional scalpel 570 (or any conventional cutting or piercing means) to start the percutaneous incision or puncture. This action is shown in Figure 13. In particular, the surgeon can make a shallow cut or nick 572, of very short length (e.g. 1mm) , into the skin 516 but not through the underlying tissue 518. Then the piercing tip of the instrument to be used can be brought into contact with the nick 572 and pressure applied thereto via the instrument, whereupon the tip and contiguous portions will easily penetrate the underlying tissue to complete the formation of the percutaneous incision or puncture. The instrument may then be manipulated as described above.

Referring now to Figures 15 to 23, the instrument 610 of Fig. 15 includes a tissue penetration means in the form of a piercing member 620 mounted at its distal end. The piercing member 620 includes a small diameter sharply pointed distal end and is mounted within the distal portion of the instrument so that it can be moved to an extended position which can be brought into engagement with the skin of the patient overlying the desired internal situs to form a small nick or cut in the skin. Once that has been accomplished the piercing member may be retracted into the distal end of the instrument or may be left extended or may be removed entirely from the instrument.

The distal portion of the elongated portion of the instrument is in the form of a pair of jaws which conjoin so that the surfaces of their distal free ends together form a tissue engagement surface. The engagement surface is somewhat rounded and blunt and is arranged to be brought into engagement with

SUBSTITUT the nick in the skin and forced therethrough and through the underlying tissue to form the percutaneous incision or puncture, as will be described later.

The jaws extend outward of the longitudinal axis of the instrument for grasping adjacent internal tissue, yet do not interfere with the passage of the elongated portion of the instrument through the percutaneous incision or puncture to the operative situs.

In the illustrations of Figures 18 to 20 there is shown the distal end of the instruments 610 of Figure 15 extending to the interior of the body via a percutaneous incision or puncture 614 extending through the skin 616 and underlying tissue 618 where it may be used, for example to reflect a lobe of the patient's liver. In order to expedite the passage of instrument 610 through the skin 616 and underlying tissue 618 to form the small percutaneous incision or puncture 614, such tissue should be supported internally as described previously.

Referring now to Figure 15 it can be seen that the instrument £10, basically comprises an elongated tubular sleeve assembly 624 which extends from a housing member (not shown but similar to that of Figure 2) . The sleeve assembly comprises an elongated sleeve 626, and an elongated rod or shaft 628 slidably mounted therein. The sleeve assembly 624 may be straight (as shown) or may be curved. In any case the distal end portion of the sleeve 626 includes an angularly oriented extension forming a jaw 630. In a similar manner the distal end portion of the shaft 628 includes an angularly oriented extension forming a jaw 632. The jaws form the working means of the instrument and are arranged to be slid with respect to each other parallel to the longitudinal axis 634 of the sleeve and rod so that then can be opened and closed.

When the jaws 630 and 632 are completely closed, such a shown by the full lines in Figure 15, they abut each other, whereupon

SUBSTITUTESHEE the outer periphery of the conjoined jaws is substantially circular. Moreover, as noted earlier, the distal end of each jaw is somewhat rounded, and when the jaws are conjoined they form the heretofore identified tissue engagement surface 620D. It is in the conjoined jaw configuration that the instrument 610 is used to pierce through the nick formed in patient's skin 616 by the piercing tip 620 so that upon the application of a force on the instrument the tissue engagement surface 62OD passes through the underlying tissue 618 to locate its jaws 630 and 632 within the body of the patient at the desired situs (as will be described later) . Moreover, that surface is sufficiently blunt so that it will not pose a hazard to internally located tissue, e.g. tissue within the insufflated abdomen.

As shown in Figure 15 jaw 630 comprises an angular extension of the distal end of the sleeve 626. The angular extension is slightly thicker than the thickness of the sleeve's sidewall and includes an inner surface 666 having a plurality of transversely extending serrations to form a good tissue grabbing surface. The jaw 632 comprises an extension of the shaft 628 and also includes a serrated inner surface 666 (see also Fig. 16) .

The cross sectional profile of each of the jaws taken perpendicularly to their longitudinal axis 668 is generally semicircular so that when the jaws are fully closed, i.e. when their serrated inner surfaces 666 abut, the profile of the conjoined jaws 630 and 632 is circular and of very small diameter, e.g. 0.094 inch (2.39 mm) or less, while the conjoined free distal end surfaces of the jaws form the heretofore described tapered or rounded piercing tip 620D.

The piercing member 620 will now be described with reference to Figures 15 and 17. As can be seen therein the member 620 basically comprises an elongated needle-like member 620A of small diameter, e.g., 1/16 inch (1.6mm) and an enlarged cap or

SUBSTITUTE SHEET head 62OB, e.g. 3/4 inch (19mm) , mounted on the top end of the member 620A. The free end of the needle-like member 620A is formed of any suitable material e.g. stainless steel, and extends through a passageway 700 (Figures 15 and 18) extending along the central longitudinal axis 668 of the conjoined jaws 630 and 632. In particular the passageway 700 is formed by conjoining longitudinally extending recesses 702 (Figure 16) in each of the jaws 630 and 632 and by a bore 700A contiguous with the recess 702 in the jaw 632. When the jaws are conjoined their recesses 702 conjoin with each other and with the bore 700A to complete the passageway 700. When the needle-like portion 620A is in place within the passageway, the cap 620B of the piercing member 620 is disposed over the portion of the instrument from which the jaws extend.

The external diameter of the needle-like member 620A is just slightly smaller than the internal diameter of the passageway 700 so that the member 620A can be slid in either direction therethrough. Accordingly, the piercing member is arranged to be slid distally through the passageway 700 by the user of the instrument pressing on its cap 620B so that its piercing tip 620C extends slightly, e.g. 2 - 2.5 mm, beyond the distal free end of the conjoined jaws. It is in this position that the piercing member 620 is ready to form the nick in the skin of the patient. The cap also serves as a convenient handle to enable the user of the instrument to grasp it during the formation of the percutaneous incision or puncture to stabilise the instrument and facilitate the formation of that incision or puncture (as will be described later) .

Once the nick has been formed by the member 620, the member 620 may be retracted by pulling on the cap 620B so that its pointed end 620C is retracted within the passageway 700 and is no longer exposed out the distal end of the instrument during the passage through the underlying tissue into the abdomen. Alternatively, the member 620 may be retracted after the distal end of the instrument has entered the abdomen. In either case,

SUBSTITUTE SHEET as will be appreciated by those skilled in the art, when the distal end of the instrument is within the patient's body and the sharp piercing tip 62OC is retracted in the instrument it will not pose a hazard to internally located tissue.

The operation of the instrument 610 to effect reflection of some internally located tissue, will now be described with reference to Figures 18 -23. To accomplish that operation the skin 616 and underlying tissue 618 of the patient's abdomen and which are located over the patient's liver 612 is preferably insufflated with any suitable gas. Once this has been accomplished the surgeon grasps the instrument 610 in one hand, and uses his/her other hand to push on the cap 62OB of the piercing member 620 to move it to the extended position shown in Figures 15 and 18.

The instrument 610 is now ready to form the percutaneous incision or puncture 614 into the patient's abdomen. To that end, as shown in Figure 18, the surgeon brings the tip 620C of the extended piercing tip 620 into engagement with the patient's skin 616 located over the operative internal situs, e.g. the insufflated abdomen, and uses one hand on the cap 620B and the other hand on the handle forming the proximal portion of the instrument to orient the instrument so that the conjoined angularly extending jaws are oriented in the desired direction, e.g. substantially perpendicular, with respect to the patient's body, as shown. The surgeon then pushes on the cap 620B of the piercing member 620 so that the perpendicularly extending portion of the apparatus is directed inward, i.e. toward the patient's abdomen. This action causes the piercing tip 620C to pierce into and through the derma a short distance, e.g. 2 - 2.5mm, to form a shallow nick 614A (Figure 18) . The piercing tip 620C may then be retracted, i.e. pulled back, so that it is within the passageway 700 like shown in Figure 19. Alternatively, the piercing tip can be left in the extended position.. In any case the surgeon continues to hold the cap of the piercing means in one hand, as shown in Figure 18 to

SUBSTITUTE SHEET stabilise the instrument, e.g. prevent it from twisting, as he/she pushes inward on the instrument using his/her other hand holding the proximal portion of the instrument. This action enables the tissue engagement surface at the free end of the conjoined jaws to pass through the nick 614A and into and through the underlying tissue 618 (as shown by the phantom lines in Figure 19) until the distal end of the conjoin jaws passes completely through the underlying tissue 618 (shown in progress in Figure 20) to enter into the abdomen, as shown in Figure 21, whereupon a small percutaneous incision or puncture 614 is formed and completed.

If the piercing tip 62OC had not been retracted into the passageway 700 yet it is retracted at this time so that it is no longer exposed. In fact, once the free end of the jaws has entered into the abdomen the piercing member is completely removed from the instrument to enable the working head, e.g. the complete jaws, to be located within the abdomen to perform the tissue reflection procedure. This procedure may then be carried out as described above with reference to Figures 10 to 12.

The passageway 700 in the conjoined jaws serves as convenient means for enabling the conventional guide wire 800 to be extended therethrough. By so doing ready access to the interior of the patient's body through the same percutaneous incision or puncture 614 may be provided. For example, after the instrument 610 has performed its desired function, a guide wire 800 can be inserted (as will be described hereinafter) , and the original instrument 610 removed, leaving the guide wire 800 in place extending through the percutaneous incision or puncture 614. Thus, if desired, another instrument 610 or a different type of instrument (not shown) can be inserted on the guide wire 800 and slid through the percutaneous incision or puncture. This action is shown in Figures 21 - 23. In particular, if it is desired to place a guide wire 800 into the patient's insufflated abdomen through the incision or puncture

SUBSTITUTE SHEET 614, this action is accomplished by moving the instrument 610 to the orientation shown in Fig. 21 whereupon the hole 700A of the passageway 700 is located outside of the patient's body, while the opposite end of the passageway 700 is within the insufflated abdomen. The distal end of the guide wire 800 can then be slid into the opening 700A and down through the passageway 700 until it is within the insufflated abdomen, as shown in Figure 21. The apparatus 610 can then be retracted out of the percutaneous incision or puncture 614 leaving the guide wire 800 in place therein, whereupon the percutaneous incision or puncture closes about the guide wire, as shown in Figure 22. With the guide wire 800 in place, another instrument having a guide wire passageway in its distal end can be threaded on the proximal portion of the guide wire 800 and slid down the guide wire so that it enters and passes through the percutaneous incision or puncture. This action is shown in Figure 23. The guide wire thus can be used to facilitate and guide -the introduction of the instrument into the insufflated abdomen.

Once the laparoscopic procedure has been accomplished the apparatus can be readily removed from within the insufflated abdomen by sliding it out along the guide wire (assuming that it had been left on the guide wire or else had been placed on the guide wire within the insufflated abdomen) . Then the guide wire 800 can be retracted out of the percutaneous incision or puncture, whereupon the incision or puncture closes and seals itself in the same manner as described earlier. As should be appreciated by those skilled in the art, if desired, the instrument and the guide wire can be removed together from the percutaneous incision or puncture if the instrument is still on the guide wire. It is, of course contemplated that the guide wire can be removed from the instrument while the instrument is in place within the patient's body. In such a case, after the guide wire is removed and the apparatus has accomplished its desired procedure it can be removed from the patient's body in the same manner as described earlier.

SUBSTITUTE SHEET Referring now to Figures 24 - 26 the details of the piercing member 200C will now be described. As can be seen therein the member 200C basically comprises an elongated somewhat tubular member 202A having a linear central passageway 204A whose inside diameter is just slightly larger than the outside diameter of the conjoined jaws 230A and 232A of instrument 240A so that those conjoined jaws can extend through the passageway 204A. In the embodiment shown herein the tubular member 202A is not a closed circular tube, but rather is a thin sheet of any suitable material, e.g. stainless steel, bent into a circular arc of approximately 270 degrees, e.g., the outside diameter of which is 0.109 inch (2.77 mm), so that its free edges define a longitudinally extending slot 206A. An enlarged cap or head 208A, e.g., 3/4 inch (19 mm), is mounted on the top end of the tubular member 202A and the cap includes a recess 210A in its undersurface to receive a portion of the conjoined jaws 230A and 232A. The free end of the tubular member 202A is cut at an angle to form a very sharp point 212A.

The piercing member 200C is arranged to be slid over the conjoined jaws 230A and 232A, i.e., the conjoined jaws being located within the central passageway 204A of the member 200C, so that its piercing point 212A extends slightly, e.g., 2 - 2.5 mm, beyond the free end of the conjoined jaws, as shown in Figure 24. It is in this position that the piercing member 200C is ready to form the nick 214A in the skin 216A of the patient, in a similar manner as described earlier. This action is shown in Figures 27 and 28.

The cap 208A serves as a convenient handle to enable the user of the instrument 210A to grasp it during the formation of the percutaneous incision or puncture to stabilise the instrument and facilitate the formation of that incision or puncture, in the same manner as described earlier.

Once the.nick in the skin of the patient has been formed by the member 200C, the member 200C may be removed or merely retracted

SUBSTITUTE SHEET by pulling on the cap 208A in a direction away from the free end of the conjoined jaws 230A and 232A. Once the member has been removed or retracted. The instrument 210A can then be used to penetrate the underlying tissue 218A to form the percutaneous incision or puncture 214B in the same manner as described earlier.

Alternatively, the member 200C may be removed or retracted after the distal end of the instrument 210A has entered the abdomen. In either case, as will be appreciated by those skilled in the art, the piercing member 200C must be removed from the conjoined jaws 230A and 232A to free them so that they can be opened before the instrument can be used to grasp internally located tissue. The removal of the piercing member from the instrument not only frees the jaws, but also eliminates any potential danger of injury to internally located tissue which could occur if the piercing tip 212A was within the insufflated abdomen.

The operation of the instrument 24OA to effect refection of some internally located tissue, e.g., a lobe of the liver 12, after the piercing member has been removed is accomplished in the same way as that described earlier/ and is shown in the illustrations of Figures 30 - 32.

In Figures 33 - 39A there are shown alternative embodiments of a piercing device constructed in accordance with this invention for carrying out the methods of this invention. Those embodiments are designated by the reference numerals 400A, 500A, and 700B. Each of these devices is arranged to be used on an instrument in a somewhat similar manner to that previously described, for example the devices 500A and 700B are configured to be used in a similar manner to that described heretofore on the instrument 610 or any other instrument 800A (Figure 37) having an angularly extending working head. The device 400A is configured to be used in a similar manner on an

SUBSTITUTESHEET alternative instrument 600A, which includes a linearly extending distal working head.

The details of each of the devices 400A, 500A, and 700B and of the instruments 600A and 800A will be described later. Suffice it for now to state that each of the devices 400A, 500A, and 700B includes a piercing tip and is arranged to be disposed on the distal end of an instrument so that the piercing tip extends beyond the free end of the working head of the instrument. The instrument with the piercing device thereon is then brought into engagement with the skin and pushed inward so that the device forms a puncture or nick of a predetermined depth through the skin and underlying tissue (in the case of abdominal surgery the depth of the nick is preferably through the skin and a portion of the subcutaneous fat, but not through the peritoneum). The device is then retracted, e.g., removed from the nick, and then the instrument is pushed inward so that the distal end of the instrument passes through the nick and through the tissue underlying that nick (e.g., the remainder of the subcutaneous fat and the peritoneum) to form or complete a percutaneous incision or puncture and to locate its working head within a desired interior portion of the being's body, (e.g. , the abdomen) without necessitating the use of a trocar or other introducing instrument.

Once the working head of the instrument is in place, as just described, it may be operated from outside the patient's body to perform its desired function, e.g., Clamping and reflecting a lobe of the liver 12 in a manner like that described earlier. At this time the tissue contiguous with the incision or puncture engages the instrument sufficiently tightly to form a fluid tight seal, e.g., a seal sufficient to preclude the egress of any insufflation gas from the interior of the patient's body.

After the procedure has been completed the instrument is retracted out of the incision or puncture whereupon it closes

SUBSTITUTESHEET and seals itself. In this regard, in accordance with a preferred aspect of this invention the piercing device and the instrument on which it is used is of a very small diameter, like that described heretofore, so that when the instrument is removed from the percutaneous incision or puncture the incision or puncture seals itself almost immediately, and only a very small scar, if any, results upon healing.

Referring now to Figures 33 - 35 the details of the piercing device 400A and the instrument 600A will now be discussed. In particular, the instrument 600A is of somewhat conventional construction and basically comprises an elongated body portion 602A having a proximal end at which a pair of handles 604A and 606A are located, and a distal end at which a working head 608A is located. The handle 604A is fixed, and the handle 606A is pivotable. The working head comprises a pair of jaws, one of which 610A being fixed, and the other 62IA being pivotable. The jaws are oriented so that when they are closed, i.e., abutting and conjoining, they extend in a direction parallel to the longitudinal axis of the elongated body portion. In particular, the surfaces of jaws which abut each other when the jaws are closed are collinear with that longitudinal axis. It must be pointed out at this juncture that the use of the term "axis" in this application (and as used previously) is in the broadest possible sense and context, and, hence, is not limited to a straight line, but can be a line of any shape, e.g., a curved line, since the body portion 602A need not be straight.

The body 602A comprises an elongated sleeve 614B whose proximal end is connected to the handle 604A. In particular, the handle 604A comprises an elongated shark 606B having a finger hole 618A at its lower end and a tubular coupling or joint 620E at its upper end. The proximal end of the elongated sleeve 614B is located and fixedly secured within the tubular joint 620E.

The fixed jaw 610A of the working head is located at the distal end of the sleeve 614B. In fact, in the jaw 610A may be formed

SUBSTITUTESHEET integrally with the sleeve 614B. The pivoting jaw 612A of the working head includes a rear projection 622A in which a pivot pin 624A is located. The pivot pin 614A is mounted within the sleeve 614B at its merger point with the jaw 610A to pivotably connect the jaw 612A to the jaw 610A. The free end of the projection extends through a hole 626A in the sleeve 614B. In order to pivot the jaw 612A with respect to jaw 610A an elongated push rod 628A is provided extending through the sleeve 214B. The distal end of the rod 628A is connected to the jaw 612A via a pivot pin 630A. The proximal end of the rod 628A is pivotably connected to the handle 606A via a pivot pin 632A. In particular, the handle 606A includes an elongated shank 634A having a finger hole 636A at its lower end and a pair of holes 638A and 640A at its upper end. The hole 638a receives the pivot pin 632A to pivotably connect the handle 606A to the rod 628A.

The pivoting handle 606A is pivotably connected to the fixed handle 604A via a pivot pin 642A which extends through the other hole 640A in the upper end of the handle 606A. The pivot pin 642A is, in turn, mounted between a pair of aligned holes in a pair of spaced projections or brackets 644A extending to the rear of the tubular joint 62OE.

The pivoting jaw 612A is arranged to be pivoted away from fixed jaw 610A the user of the instrument spreading the handles 604A and 606A apart by his/her fingers in the finger holes 618A and 636A, respectively, whereupon tissue can be located in the mouth between the open jaws. The jaws can then be used to grasp that tissue by squeezing the handles together, thereby causing the jaw 610A to pivot towards the jaw 612A. In order to facilitate the grasping of tissue each of the jaws includes plural serrations 646A on its tissue engagement surface.

When the jaws 610A and 612A are completely closed, such as shown by the full lines in Figure 35, they abut each other, whereupon the outer periphery of the conjoined jaws is

SUBSTITUTESHEET substantially circular and of the very small cross sectional area, like that discussed earlier. Moreover, the distal end of each jaw is somewhat rounded, and when the jaws are conjoined they form the heretofore identified tissue engagement surface. It is in the conjoined jaw configuration that the instrument 600A is used to pierce through the nick formed in patient's skin and underlying tissue. That nick is formed by the piercing device 400A.

The piercing device 400A basically comprises an elongated somewhat tubular member 402A which is constructed similarly to tubular member 202A of the device 200A described earlier. Thus, the member 402A has a linear central passageway 404A whose inside diameter is just slightly larger than the outside diameter of the conjoined jaws 610A and 612A so that those conjoined jaws can extend through the passageway 404A. The tubular member 402A is not a closed circular tube, but rather is a thin sheet of any suitable material, e.g., stainless steel, bent into a circular arc of greater than 180 degrees so that its free edges define a longitudinally extending slot 406A. An enlarged cap or head 408B is mounted on the top end of the tubular member 402A and the cap includes a recess 410A in its undersurface to receive a portion of the conjoined jaws 610A and 612A. The free end of the tubular member 402A is cut at an angle to form a very sharp point 412A.

A handle 414A is mounted on the cap 408B. The handle basically comprises a pair of looped members defining finger holes 416C and 418A. The looped member defining the finger hole 416C is split into two sections 416A and 416B so as to create a space or slot 420A (Figure 34) between the split sections. The slot 420A is aligned with the slot 406A in the tubular member 402A in order to enable the conjoined jaws 610A and 612A of the instrument 600A to be passed laterally through the slot 420A and through the slot 406A to snap fit with the interior of the passageway 404A in the tubular member 402A.

SUBSTITUTE SHEET The device 400A is slidable with respect to the conjoined jaws so at its pointed end 412A extends slightly, e.g., 2 - 2.5 mm, beyond the rounded free ends of the conjoined jaws 610A and 612A. It is in this position that the piercing member 400A is ready to form the nick in the skin 616A and some underlying tissue 618A of the patient to start the formation of the percutaneous incision or puncture. In order to hold the device 400A in the desired extended position its tubular member 402A includes a small dimple or detent 422A arranged to engage the instrument 600A at the point at which the pivoting jaw 612A is- connected to the push rod.

In accordance with a preferred embodiment of this invention the device 400A is arranged to pierce the skin and underlying tissue to form a nick of a predetermined depth. For example, for applications wherein access to the abdomen is desired, the device 400A is arranged to produce a nick whose depth extends through the skin 616A and through a portion of the underlying subcutaneous fat and fascia 618A, but not through the peritoneum 619A. This automatic depth penetration control is accomplished by the inner surface of the cap making contact with the surface of the skin. To that end the length of the tubular member 402A is selected so that its pointed end 412A will reach the maximum depth desired for the nick at the time that the inner surface 08A of the cap makes contact with the patient's skin.

The finger holes 416C and 418A of the handle enable the user of the instrument 400A to grasp it during the formation of the percutaneous incision or puncture to stabilise the instrument and facilitate the formation of that incision or puncture, in the same manner as described earlier.

Once the nick in the skin and underlying tissue has been formed to the appropriate depth by the device 400A, the device 400A is removed by pulling on the finger holes of the cap in a direction away from the free end of the conjoined jaws 610A and

SUBSTITUTE SHEET 612A. Once the device 400A has been removed the instrument 600A can then be used to penetrate the tissue, e.g., the peritoneum 619A, underlying the nick to form, i e. , complete, the percutaneous incision or puncture in the same manner as described earlier. This action locates the working head at the desired internal position, whereupon it can be operated to open its jaws to grasp and reflect tissue, e.g., to reflect the lobe of the liver as described earlier.

Like before, the removal of the piercing member 400A from the. instrument 600A not only frees the jaws, but also eliminates any potential danger of injury to internally located tissue which could occur if the piercing tip 412A was within the insufflated abdomen since the surfaces of the jaws are sufficiently blunt to pose no hazard to internally located tissue, e.g., tissue within the insufflated abdomen.

In Figure 36 there is shown an alternative embodiment 500A of the piercing device. That device is similar in construction to the device 400A, except that its cap includes a single finger ring. Moreover, the device 500A is used in the same manner as described with reference to the device 400A. Thus, in the interests of brevity the components of the device 500A which are the same as those of device 400A are given the same reference numbers and their description will not be reiterated.

The cap 408B of the device 500A has a finger ring 502A projecting upward therefrom. The finger ring 502A includes a slot 504A in it. This slot is similar to the slot 410A described heretofore, except that it is angled so that the device 500A can be used on an angled working head instrument, like the instrument 610 or the instrument 800a shown in Figure 37. The instrument 800A is identical in construction to the instrument 600A except that its working head jaws 610' and 612' extend at an acute angle to the longitudinal axis of the body 802 of the instrument. In the interest of brevity the details

SUBSTITUTE SHEET of the construction and operation of the instrument 800A will not be reiterated.

In Figure 36A there is shown a plan view of the nick or puncture formed by the devices 400A and 500A. Thus, as can be seen the portion of the puncture or nick, formed by the piercing tip is shown by the solid line designated by the reference letter "N", and is of arcuate shape and extends for a substantial portion, e.g., approximately 180 degrees. The remainder of the puncture or nick is shown by the phantom lines, and designated by the reference letter "I", represents the boundary of the percutaneous incision or puncture formed by the instrument passing through the nick to open it further, dilate it. In order to minimise the size of the puncture or nick formed by the piercing device of this invention, the piercing tip may be formed like that shown in the embodiment of the device 700A of Figure 38. That embodiment is identical in all respects to the embodiment 500A except that the piercing tip 712 comprises a sharp leading cutting edge 712A for piercing tissue, i.e., forming the nick or puncture, and a trailing, blunt spreading edge 712B disposed proximally of said leading cutting edge for spreading the tissue cut by said leading cutting edge. Figure 38A is a plan view similar to that of Figure 36A, but showing the puncture or incision "N" formed by the device 700A. As can be seen therein the incision is of smaller size and will thus leave less of a scar.

The following constitutes the detailed description of a preferred embodiment of the piercing instrument with means to adjustably establish the depth of penetration of the piercing member:

Referring now to Figures 39 - 44 the details of the piercing device 1000 will now be considered. As can be seen therein the piercing device 1000 is particularly adapted for use with the instrument 600A described earlier. However, it may be modified so that it can be used with any of the instruments described

SUBSTITUTESHEET heretofore. Thus, the piercing device 1000 is similar in basic concept to the piercing device 400A, described above, except that it is constructed to be able to adjust the distance that its piercing tip will penetrate the skin and underlying tissue. With the device 400A the depth of tip penetration is controlled automatically by the inner surface of the cap making contact with the surface of the skin. The length of the tubular member 402A is preselected for the patient, so that the pointed end 412A will reach the maximum depth of penetration at the time that the inner surface 408A of the cap makes contact with the patient's skin. This arrangement, while suitable for its intended purposes is of limited utility since it requires different length piercing members for different patients depending upon the thickness of the patient's abdominal tissue.

In the embodiment 1000 the device includes user adjustable means, to be described hereinafter, for adjusting the distance between the sharply pointed end of the piercing member and the inner surface of a stop member which makes contact with the patient's skin so that the depth of penetration can be established at any desired value consistent with the patient's abdominal wall thickness. Moreover, as will also be described later, the device 1000 includes means for releasably securing the instrument 600A within it at any desired longitudinal position.

As can be seen in Figure 39 the piercing device 1000 basically comprises an elongated, somewhat tubular, member formed of any suitable material, e.g., type 303 or 304 stainless steel. That member is constructed like the tubular member 402A of the device 400A and hence its components will be given the same reference numerals as in the device 400A. Like the member 402A of the device 400A the member 402A of the device 1000 has a linear central passageway 404A whose inside diameter is just slightly larger than the outside diameter of the conjoined jaws 610A and 612A and shark 628A of the instrument 600A so that those conjoined jaws and the adjacent shark of the instrument

SUBSTITUTESHEET can extend through the passageway 404A until the free end of the conjoined jaws is slightly retracted from the sharp piercing point 412A.

The device 1000 also includes an adjustable depth stop 1002 which is coupled to the elongated piercing member 402A for movement therealong (as will be described later) . The depth stop 1002 is formed of any suitable material, e.g., acetal or ABS plastic, and basically comprises a cylindrical member whose distal end is in the form of a flange 1004. The portion of the adjustable depth stop 1002 from the flange 1004 to its proximal end is cylindrical and is externally threaded at 1006 along its length. A passageway 1008 extends through the depth stop 1002 centred on the longitudinal central axis of the depth stop. The tubular piercing member 402A extends through-the passageway 1008, so that its proximal end portion 1010 is located outside of the proximal end of the adjustable depth stop. The proximal end portion of the tubular piercing member 402A is fixedly secured to a housing member 1012, also forming a portion of the device 1000 and which will be described later.

A slot 1014 extends radially outward from the central passageway of the depth stop along the entire length thereof and is arranged to be oriented so that it is aligned with the slot 406A in the elongated member 402A to enable the distal end portion of the instrument 600A to be inserted within the interior of the elongated piercing member 402A, as will be described later.

The externally threaded proximal end portion 1006 of the adjustable depth stop is located within a correspondingly internally threaded bore 1016 in the housing member 1012.

The housing member, serves as the handle for the piercing device 1000. It is formed of any suitable material, e.g., acetal or ABS plastic, and basically comprises a cylinder whose distal end includes the heretofore identified internally

SUBSTITUTE SHEET threaded bore 1016. A central passageway 1018 extends through the housing member 1012 centred on the longitudinal axis of that member and is axially aligned with the passageway 1008 in the adjustable depth stop. The proximal end of the elongated tubular piercing member 402A is located and fixedly secured within the central passageway 1018 in the housing member 1012 by any suitable means, e.g., an adhesive. A slot 1020 extends radially outward from the central passageway 1018 of the housing member along the entire length thereof. The slot 1020 is arranged to be oriented with respect to the adjustable depth stop 1002 so that it is aligned with the slot 1014 in the depth stop and with the slot 406A in the elongated member 402A to enable the distal end portion of the instrument 600A to be inserted within the interior of the elongate piercing member 402A, as will be described later.

The proximal end of the housing member 1012 includes a circular recess 1022 which is eccentrically disposed with respect to the longitudinal central axis of the internally threaded bore 1016 of the housing member and the aligned passageways 1018 and 1008. The recess 1022 is adapted to receive a locking member 1024 for locking the instrument 600A within the tubular piercing member 402A at any desired longitudinal position therealong.

The locking member 1024 is clearly shown in Figure 40 and basically comprises a cylindrical bushing having a central passageway 1026 extending therethrough and a slot 1028 extending radially outward from the passageway 1026 along the length of the bushing. The slot 1028 is provided to enable the instrument 600A to be inserted within the interior of the elongated piercing member 402A (as will be described later) .

The proximal end of the bushing is in the form of a knurled cap 1030. The bushing can be formed of any suitable material, such as that forming the adjustable depth stop 1002 and the body 1012. The bushing 1024 includes a groove 1032 extending about

SUBSTITUTESHEET its periphery. A pin 1034, formed of any suitable material, e.g., type 303 stainless steel, extends inward radially through the body into the eccentric recess 1022 so that the inner end of the pin 1034 is located within the groove 1032, thereby holding the locking member in place within the eccentric recess, yet enabling the locking member to be rotated about the central longitudinal axis of the piercing member 1000.

The instrument 600A is inserted into the hollow interior of the piercing member 402A by rotating the adjustable depth stop 1002 about its longitudinal axis until its slot 1014 is aligned with the slot 1020 in the housing 1012, and by rotating the locking member 1024 within the eccentric recess 1022 until the slot 1028 in the locking member is aligned with the aligned slots 1014 and 1020. The distal end of the instrument 600A can then be inserted radially inward through the aligned slots into the interior of the elongated piercing member 402A. Once inside the elongated piercing member the instrument 600A can be slide up or down that member until the device's pointed end 412A is located a desired distance, e.g., 2 - 2.5 mm, beyond the rounded free ends of the conjoined jaws 610A and 612A. It is in this position that the piercing member 1000 is ready to form the nick in the skin and some underlying tissue of the patient to start the formation of the percutaneous incision or puncture in the same manner as described heretofore.

In order to lock the instrument 600A in this position with respect to the piercing device 1000 all that is necessary is to rotate the locking member 1024 within the eccentric recess 1022, whereupon the shank portion 628A of the instrument 600A will be jammed by the locking member.

In accordance with a preferred embodiment of this invention the device 1000 is arranged to pierce the skin and underlying tissue to form a nick of any predetermined, adjustable depth. For example, for applications wherein access to the abdomen is desired, the device 400A is arranged to produce a nick whose

SUBSTITUTE SHEET depth extends through the skin 616A and through a portion of the underlying subcutaneous fat 618A, but not through the peritoneum 619A. This automatic depth penetration control is accomplished by the inner surface of the flange 1004 making contact with the surface of the skin. To establish the spacing between the piercing point 412A of the piercing member 402A and the inner surface of the flange 1004 the adjustable depth stop 1002 is rotated about its longitudinal axis to either move it distally or proximally with respect to the housing 1012 and to the tubular piercing member 402A fixedly secured to the . housing. Accordingly, the distance between the inner surface of the flange 1004 and the tip 412A can be established so that the tip 412A will reach the maximum depth of penetration desired at the time that the inner surface of the flange 1004 makes contact with the patient's skin.

Once the piercing member has penetrated to the desired depth the device 1000 may be removed or merely retracted. This action is accomplished by releasing, i.e., rotating, the locking member 1024 within the recess 1022 to unjam the shank 628A of the instrument from the locking member. Then the housing 1012 can be pulled outward, i.e., in a direction away from the free end of the conjoined jaws 610A and 612A until the device is out of the percutaneous incision or puncture but still on the instrument 600A or completely off of the instrument. In any case the instrument 600A can then be used to penetrate the tissue, e.g., the peritoneum, underlying the nick to form, i.e., complete, the percutaneous incision or puncture in the same manner as described earlier. This action locates the working head at the desired internal position, whereupon it can be operated to open its jaws to grasp and reflect tissue, e.g. , to reflect the lobe of the liver as described earlier.

Like before, the removal of the piercing member 1000 from the instrument 600A not only frees the jaw, but also eliminates any potential danger of injury to internally located tissue which

SUBSTITUTESHEET could occur if the piercing tip 412A was within the insufflated abdomen since the surfaces of the jaws are sufficiently blunt to pose no hazard to internally located tissue, e.g., tissue within the insufflated abdomen.

It will be appreciated that various modifications can be made without departing from the scope of the invention. For example, the piercing member may be tubular or part tubular and designed to pass over the jaws in their conjoined position rather than passing inside them.

SUBSTITUTE SHEET

Claims

1. An instrument (200A, 200B) for performing a medical procedure in the body of a living being, the instrument having a proximal portion and a distal portion, the proximal portion being arranged to be located outside the body and the distal portion being arranged to be located within the body, the distal portion being elongated and having working means to carry out the procedure and tissue penetrating means to form a small percutaneous incision in the body to enable the distal portion with the working means to be inserted through the incision into the body, the incision being sufficiently small that it is quickly self-sealing after the instrument has been removed therefrom, characterised in that the tissue penetrating means comprises a piercing member (310,400,620,200C) moveable from its exposed piercing configuration to a safety configuration after making the incision and in that the distal portion (210) and working means (210,212; 630,632; 230A,232A) are insertable through the incision to the desired location without the use of a trocar or other porting means.

2. An instrument according to Claim 1, wherein there are at least two working means each extending laterally of the longitudinal axis of the distal portion and at least one of the working means being actuable with respect to the other.

3. The instrument of Claim 1 or 2, wherein the working means comprise a pair of jaws (210,212; 630,632; 230A,232A) which are arranged to be moved relative to each other in directions generally parallel to the longitudinal axis of the distal portion.

SUBSTITUTE SHEET

4. The instrument of Claim 1, 2 or 3, wherein the proximal portion (202) includes actuating means to actuate the working means (210,212).

5. The instrument of any preceding Claim, wherein the piercing means comprises a piercing tip (400) pivotally connected to the distal end of the apparatus whereby it can be moved to a safety configuration.

6. The instrument of Claim 1,2,3 or 4, wherein the piercing means comprises a piercing tip (300) releasably secured to the distal end of the apparatus, whereupon it may be removed therefrom after forming the incision.

7. The instrument of Claims 4,5 or 6, wherein the piercing tip (300) forms a portion of at least one of the jaws (210,212).

8. The instrument of Claim 5, in which the tip (400) also has an arcuate surface that can be pivoted to present the safety configuration.

9. An instrument according to any preceding Claim, which comprises a distal portion, an intermediate portion and a proximal portion, and in which the distal portion and a portion of the intermediate portion are arranged to be located within the body.

10. An instrument (510) for performing a medical procedure in the body of a being, the apparatus having a proximal portion and a distal portion (524) , the proximal portion being arranged to be located outside the body and the distal portion being arranged to be located within the body, the distal portion being elongated and having working means (530,532) to carry out the procedure and

SUBSTITUTE SHEET piercing means (520) to form a small percutaneous incision in the body to enable the distal portion with the working means to be inserted through the incision into the body, the incision being sufficiently small that it is quicKly self-sealing after the apparatus has been removed therefrom, characterised in that the piercing means has a tip (520) that is shaped to be insertable through skin and tissue under pressure but sufficiently blunt not to present a cutting hazard to tissue or organs . within the body and in that the distal portion (524) and working means (530,532) are insertable through the incision without the use of a trocar or other porting means.

11. The instrument of Claim 10, wherein the working means comprise a pair of jaws (530,532) which are arranged to be moved relative to each other in directions generally parallel to the longitudinal axis (534) of the distal portion (524) .

12. The instrument of Claim 11, wherein each of the jaws (530,532) is arranged to be moved from a retracted position located close to the longitudinal axis (534) of the distal portion (524) to an extended position wherein the jaws project outward laterally a substantial distance from the longitudinal axis (534)

13. The instrument of Claim 11 or 12, wherein the piercing tip (520) forms a portion of at least one of the jaws.

14. The instrument of any of Claims 11 to 13, wherein the proximal portion includes actuating means to actuate the working means (530,532).

SUBSTITUTE SHEET

15. The use in a medical procedure in an interior portion of the body of a living being from outside the body of the being via a small percutaneous incision or puncture of an instrument, the instrument (510) having a proximal portion; a distal portion (524) , wherein the distal portion comprises working means (530,532) and a tip (520), the tip

(520) having a tissue engagement surface which is sufficiently blunt so as not to present a hazard to tissue or organs located within the interior portion of the being, in which the skin (516) and tissue (518) over the interior portion are supported and the tissue engagement surface is brought into engagement with the skin over the interior portion and pressure is applied thereto to pass through the skin and underlying tissue to form the percutaneous incision or puncture (514) , the working means (530,532) of the instrument is moved through the percutaneous incision or puncture without using a trocar or other porting means so that the working means is at a desired position within he interior portion of the being, the working means are operated from outside the body of the being so that the working means performs the procedure, and then the instrument is withdrawn out of the incision or puncture.

16. The use of an instrument according to Claim 15, wherein the interior portion is insufflated to support the skin and tissue over the interior portion.

SUBSTITUTESHEET

17. The use of an instrument according to Claim 15 or 16, wherein a nick (572) is made in the skin (516) but not through the underlying tissue (518) and thereafter the tip (520) is brought into engagement with the nick and pressure is applied to start the percutaneous incision or puncture (514) from the nick.

18. The use of an instrument according to Claim 17, in which the nick (572) is made by another instrument, for example a scalpel (570) .

19. An instrument (610) for performing a medical procedure in the body of a living being, the apparatus having a proximal portion and a distal portion (624) , the proximal portion being arranged to be held outside the body and the distal portion being arranged to be located within the body, the distal portion (624) being elongated and having working means (630,632) to carry out the procedure and tissue penetration means (620) , characterised in that the tissue penetration means (620) comprises a small diameter elongated member (620A) having a sharp tip (620C) removably mounted at the distal portion in an extended position, where it is exposed so that it may be arranged to extend through the skin and tissue to form a small percutaneous incision or puncture therethrough upon application of force to the instrument, the working means being connected to the tip so as to pass into the interior portion without the use of a trocar or other porting means, the sharp tip being removable from the instrument to a retracted position when the working means is within the body and the working means comprising at least two actuable means (630,632) projecting laterally of the longitudinal axis of the distal portion.

SUBSTITUTESHEET

20. An instrument according to Claim 19, which also comprises tissue engagement means (620D) having a surface to engage a nick formed by the sharp tip (620C) and be extended therethrough to form the percutaneous incision (614) upon the application of force to the apparatus so that the working means (630, 632) of the distal portion passes through the incision into the interior portion, the surface of the engagement means (620D) being sufficiently blunt so as not to present a hazard to tissue or organs, located within the interior portion.

21. An instrument according to Claim 19 to 20, wherein the working means comprises a pair of jaws (630,632) at least one of which is movable relative to the other in a direction parallel to the longitudinal axis of the distal portion.

22. An instrument according to Claim 21, wherein the jaws (630,632) each extend at an acute angle to the longitudinal axis of the distal portion and the tissue penetrating means comprises an elongated member at which the sharp tip is located, the elongated member (620) being removable from the instrument.

23. The instrument of any one of Claims 19 to 22, wherein the proximal portion of the instrument includes a handle portion arranged to be held by the user to stabilise the apparatus and facilitate passage through the small incision.

24. The instrument of any one of Claims 19 to 23, wherein the proximal portion includes means arranged to be manually operated to cause at least use of the working means to move relative to the other.

SUBSTITUTESHEET

25. The instrument of any one of Claims 21 to 24, wherein the tissue engagement surface (620D) comprises a portion of at least one of the jaws (630,632) .

26. The instrument of any one of Claims 21 to 25, wherein the tissue engagement surface comprises an elongated member (620) mounted on at least one of the jaws.

27. The instrument of Claim 26, wherein the elongated member (620) additionally comprises a cap (620B) arranged to be operated by the user to effect the movement of the elongated member (620A) to the extended position.

28. An instrument (610) for performing a medical procedure in the body of a living being, the apparatus having a proximal portion and a distal portion (624) , the proximal portion being arranged to be held outside the body and the distal portion being arranged to be located within the body, the distal portion (624) being elongated and having working means (630,632) to carry out the procedure and tissue penetration means (620) , characterised in that the tissue penetration means (620) comprises a small diameter elongated member (620A) having a first pointed tip (620C) arranged to be moved to an extended position, whereupon the first tip (620C) is exposed so that it may pierce the skin to form a small nick therethrough, and engagement means comprising a second tip (620D) having a surface arranged to engage and be extended through the small nick and through the underlying tissue to form the percutaneous incision (614) upon the application of force to the apparatus so that the distal portion (624) and working means (630,632) passes through the

SUBSTITUTESHEET incision into the interior portion without the use of a trocar or other porting means, the surface of the second tip (620D) being sufficiently blunt so as not to present a hazard to tissue or organs located within the interior portion and in that coupling means (628) are provided to couple the working means and proximal portion to effect the operation of the working means via the proximal portion.

29. The instrument of Claim 28, wherein the distal portion of the Instrument includes a handle portion arranged to be held by the user to stabilise the apparatus and facilitate passage through the small Incision.

30. The instrument of Claim 28 or 29, wherein the tissue penetration means (620) is retractable to a retracted position so that tissue within the body is not exposed to the first tip (620C) when the distal end of the apparatus is located within the interior portion of the body.

31. The instrument of Claim 29 or 30, wherein the handle portion comprises a cap (62OB) connected to the first tip, whereby the cap can be operated by one hand of the user to effect movement of the elongated member (620A) to the extended position.

32. The instrument of any one of Claims 28 to 31, wherein the distal portion comprises a passageway (700) therein.

33. The instrument of Claim 32, wherein the passageway (700) is of a small diameter for receipt of a guide wire (800) therethrough.

SUB_STITUTESHEET

34. The instrument of Claim 32 or 33, wherein the small diameter elongated member (620A) of the tissue penetration means (620) extends through the passageway (700) , with the pointed tip (620C) being arranged to be moved to an extended position so that it extends outside of the passageway (700) and is exposed.

35. The instrument of Claim 34, wherein the tissue penetrating means (620) is removable from the passageway (700) .

36. The instrument of any one of Claims 28 to 35, wherein the small diameter elongated member (620A) of the tissue penetration means (620) comprises a rod-like member which extends through a passageway (700) In the distal portion (624) of the apparatus.

37. The instrument of any one of Claims 29 to 35, wherein the small diameter elongated member of the tissue penetration means comprises a tubular member (202A) having a central passageway (204A) through which the distal portion of the apparatus extends, the tubular member having a free end forming the pointed tip (212A) .

38. An instrument for performing a medical procedure in the body of a living being, the apparatus having a proximal portion, a distal portion, working means, coupling means and tissue penetrating means, the proximal portion being arranged to be held outside the body and the distal portion being arranged to be located within the body, the distal portion being elongated, the coupling means being coupled to the working means and the proximal portion to effect the operation of the working means via the proximal portion characterised in that the tissue penetrating

SU_BSTITUTESHEET means has a surface (620D) to engage and be extended through the skin of the being and the underlying tissues by the application of force to form a small percutaneous incision (614) whereby the distal portion (624) and the working means (630,632) can pass through the incision (614) to the Interior of the body without use of a trocar or other introducing Instrument and In that the distal portion (624) includes a small diameter passageway (700) through which a guide wire (800) can be extended.

39. The apparatus of Claim 38, wherein the working means comprises a pair of jaws (630, 632) which are arranged to be moved relative to each other in directions generally parallel to the longitudinal axis (634) of the distal portion.

40. The instrument of Claim 38 or 39, wherein the proximal portion includes means arranged to be manually operated to cause said jaws (630,632) to move relative to each other via the coupling means.

41. The apparatus of Claims 38 39 or 40 wherein the surface (620)0) of said tissue engagement means comprises a portion of at least one of said jaws (630,632) .

42. An apparatus according to any one of Claims 38 to 41, wherein the apparatus (610) can be withdrawn from the incision (614) to leave the guide wire (800) in place therein.

SUBSTITUTE SH_έET

43. A piercing device for use with an instrument according to any one of Claims 19 to 42, wherein the device comprises an elongated tubular member (202A, 402A) having a passageway (204A, 404A) for movably mounting the device on the instrument so that the distal portion of the Instrument extends into the passageway (204A, 404A) , the elongated tubular member (202A, 404A) having a piercing tip (212A, 412A) and being movable to an extended position with respect to the instrument, whereupon the piercing tip (212A, 412A) is exposed so that it may be pushed to pierce the skin and a first portion of underlying tissue to form a nick of a predetermined depth, the tubular member (202A, 402A) , being thereafter movable to withdraw the tip (212A, 412A) from the nick, the distal portion of the instrument being pushable so that when pushed the distal portion of the Instrument passes through the nick and through further underlying tissue to form the percutaneous incision or puncture, whereupon the working means is located within the interior portion of the body of the being without the use of a trocar or other porting means.

44. The device of Claim 43, additionally comprising a handle portion (208A, 416A, 416B, 416C) secured to the small diameter tubular member (202A, 402A) and arranged to be held by the user of the instrument to facilitate the formation of the nick.

45. The device of Claim 44, wherein the piercing device is removably mounted on said instrument so that it may be withdrawn from the nick and removed from the instrument before the instrument is pushed to form the percutaneous Incision or puncture.

^SUB^STITUTE SHEET

46. The device of Claim 43 to 45, wherein the tubular member includes a slot (206A. 406A) extending down the length thereof.

47. The device of any one of Claims 43 to 46, wherein said piercing tip (212A, 412A) Includes a pointed tip.

48. The device of any one of Claims 43 to 47, which includes stop means (408A, 1002) spaced distally from the piercing tip (412A) whereby a nick of predetermined depth may be formed, the depth being established by engagement of the stop means with the skin (616A) of the being.

49. The piercing device of Claim 48, which has adjustable means (1002, 1012) to vary the distance between the stop means (1002) and the piercing tip (412A) .

50. The piercing device of Claim 49, wherein the adjustable means comprises cooperating rotating screw-threaded members (1012,1006) .

51. The piercing device of Claim 50, wherein the stop means (1002) has a central longitudinal passageway

(1008) to receive an instrument (600A) and a slot (1014) extending radially outwardly from central passageway (1008) whereby slot (1014) can be aligned with the passageway (404A) of the elongated tubular member to enable the Instrument (600A) to be inserted.

SUBSTITUTESHEET

52. The piercing device of any one of Claims 43 to 51, wherein the tubular member (402A) is provided with locking means (422A) to removably lock it to the distal portion of the instrument when it is mounted thereon.

53. The piercing device of claim 52 wherein the locking means is a dimple or detent (422A) to engage a corresponding portion of the instrument.

54. The piercing device of Claim 52, wherein the locking means comprises an eccentric recess (1022) at the proximal end of the device and a locking member (1024) to be received In the recess (1022) and rotatable therein.

55. The piercing device of Claim 54, wherein the locking member (1024) has a peripheral groove (1032) to receive the inner end of a pin (1034) to locate the member In the recess while allowing the member (1024) to rotate therein.

56. The piercing device of Claim 54 or 55, wherein the locking member (1024) is a cylindrical bushing having a central passageway (1026) therethrough and a slot (1028) extending radially outwards from the passageway (1026) along the length of the bushing whereby the slot (1028) can^" be aligned with the passageway (404A) of the elongated tubular member to enable an instrument (600A) to be inserted into the device.

SUBSTITUTESHEET