MXPA99000561A - Applicator and method for deploying a surgical fastener in tissue - Google Patents

Abstract

An applicator (5) for deploying a fastener into tissue, the fastener including a head portion and a filament portion extending from the head portion, the applicator comprising an elongated hollow needle member (500) having a pointed distal end portion, a slotted portion for releasably retaining the head of the shaped fastener, and a first connector portion;and a chuck comprising a second connector portion engageable with the first connector portion for interconnecting the needle member and the chuck, a push rod (205) having a distal end portion adapted to move lengthwise in the needle member, and an actuator (220) for moving the push rod in the needle member so as to eject the head portion of the fastener from the slotted portion of the needle member. A method for deploying the fastener in tissue is also disclosed.

Description

APPLICATOR AND METHOD FOR DEPLOYING A SURGICAL CLIP INSIDE A TISSUE Field of the Invention This invention relates to a surgical apparatus and methods in general and, more particularly, to applicators and methods for deploying surgical fasteners within weaves. BACKGROUND OF THE INVENTION In many situations, a piece of tissue must be joined to another piece of tissue. For example, an open wound or surgical incision may need to be closed. Or an injury can cause a piece of tissue (for example, a tendon) to detach itself from another piece of tissue (for example, a bone). Or a piece of tissue (for example, a piece of meniscus cartilage) can tear in its middle part. The traditional technique for joining a piece of soft tissue to another piece of soft tissue has involved stitching the two pieces of tissue together using suture. However, in many circumstances, such sewing can be problematic, or due to the time required to make the seam, or the difficulty of sewing on a particular area of the body, etc.

More recently, different types of surgical fasteners have been developed to hold two pieces of tissue together. Among the fasteners that have been developed so far is the so-called T-type fastener, in which a rod-like head is mounted perpendicularly to the end of a stretch of flexible filament. Another of these fasteners is the so-called type H fastener, in which rod-type heads are mounted perpendicular to the two opposite ends of a flexible intermediate bridge filament. Appropriate applicator tools have also been developed to deploy such fasteners within the tissue. Examples of these type T and type H fasteners, and their associated applicators, are described in And patents of E. U. A., Nos. 4,006,747 (Kronenthal et al.); 4,235,236 (Ogiu et al.); 4,669,474 (Richards et al.) And 4,705,040 (Mueller et al.). Unfortunately, applicators for deploying such H-type and T-type fasteners within the tissue have not been completely satisfactory so far, for a variety of reasons.

OBJECTS OF THE INVENTION As a result, an object of the present invention is to provide an improved applicator for deploying T-type and H-type fasteners within the scope of the invention. > f woven. Another object of the present invention is to provide an improved method for deploying type H 'type T' fasteners within the fabric. SUMMARY OF THE INVENTION These and other objects are addressed by the present invention, which comprises an improved applicator and a method for deploying T-type and H-type fasteners within the tissue. In a preferred form of the invention, the applicator for deploying the T-type and H-type fasteners within the tissue, comprises an elongated hollow needle element, having a sharp distal end portion, a slotted portion for retaining, releasable form, the configured fastener head, and a first connector portion; and a tool holder comprising a second connector portion, which can be coupled with the first connector portion, for interconnecting the needle element and the tool holder, a push rod, having a distal end portion, adapted to move longitudinally in the needle element, and an actuator for moving the push rod within the needle element, so as to eject the head portion of the fastener from the slotted portion of the needle element. In a preferred form of the invention, the method for deploying T-type and "H-type" fasteners within a fabric, comprises the steps of: placing a "head portion of the fastener inside a slotted portion of a needle element" hollow joining this needle element to a tool holder, which extends from a tool; manipulate * the tool for sliding a sleeve over a joint of the needle element and the tool holder, in order to lock the needle element in this tool holder; advancing the needle element within the body to a point at which the slotted portion of the needle element is adjacent to an area in which the fastener is positioned; and manipulating the tool to move a push rod centrally of the tool holder, "so as to engage the clip and eject the head portion of the clip from the slotted portion of the needle element.

Brief Description of the Drawing These and other objects and features of the present invention will become more fully described or will be obvious from the following metallised description of the preferred embodiment of the invention, which will be considered in conjunction with the accompanying drawings, in which numbers similar refer to similar parts and further where: Figure 1 is a side view of an applicator formed in accordance with the present invention, with the applicator being shown in a first operating position; Figure 2 is an enlarged side view of the distal end of the applicator shown in Figure 1; Figure 3 is a side view of the applicator of Figure 1, with the applicator being shown in a second operating position; Figure 4 is an enlarged side view of the distal end of the applicator, shown in Figure 3; Figure 5 is a side view of the applicator of Figure 3, with this applicator being shown in a third operating position; Figure 6 is an enlarged side view of the distal end of the applicator shown in Figure 5; Figure 7 is a side view of the applicator of Figure 1, with this applicator being shown in a fourth operating position; Figure 8 is an enlarged side view of the distal end of the applicator shown in Figure 7; Figure 9 is a side view of the applicator of Figure 1, with the applicator being shown in a fifth operating position; Figure 10 is an enlarged side view of the distal end of the applicator shown in Figure 9, - Figures 11 to 14 are views showing construction details of selected portions of the push rod assembly of the applicator; Figures 15 to 19 are views showing construction details of selected portions of the applicator toolholder assembly; Figures 20 to 23 are views showing construction details of selected portions of the applicator sleeve assembly; Figures 24 to 27 are views showing details of construction of selected portions of the applicator needle assembly; Figure 28 is a perspective view showing a type of fastener, which can be used in conjunction with the present invention; Figure 29 is a perspective view showing a tray for retaining the needle assembly of the applicator, before joining the needle assembly with the rest of the applicator; Figures 30 to 40 are schematic views showing various stages in the use of the applicator in an exemplary tissue repair application; Figure 41 shows an alternative needle assembly, which may be used in connection with the present invention; Figure 42 shows an alternative tray, which can be used in relation to the alternative needle assembly shown in Figure 41; Figure 43 shows an alternative type of fastener, which can be used in conjunction with the present invention; Y . Figures 44 to 46 are schematic views showing several possible alternative constructions for the needle and tool holder assemblies of the applicator.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT By first looking at Figures 1 and 2, an applicator 5 formed according to the present invention is shown. The applicator 5 generally comprises a housing 100, a push rod assembly 200, a tool holder assembly 300, a sleeve assembly 400 and a needle assembly 500. The housing 100 is preferably formed in the configuration of a gun-type grip, so as to be easily shaped in the hand of a user. This housing 100 serves to provide a support structure for the rest of the elements of the applicator, as will be described later in detail. The housing 100 is preferably formed as two mirror halves (only one of which is shown in Figure 1) to thereby simplify the manufacture of the applicator, with the two halves being joined during the assembly, in order to form the complete structure of the housing. Looking at Figures 1, 2 and 11 to 14, the push rod assembly 200 generally comprises a push rod 205, a sliding block (or sledge) 210, a pivot lever 215, an actuator 220 and a spring 225. The proximal end of the push rod 205 is preferably solid and secured to the sliding block 210, so that the push rod 205 will move in unison with the slide block 210. The distal end of the push rod 205 preferably comprises a flexible, but relatively incompressible, spring 205A, by which the push rod can follow the curvature of the needle assembly 500, as will be discussed later in greater detail. The pivot lever 215 and the actuator 220 are pivotally mounted to the housing 100, whereby (i) when the actuator .220 is in its forward position (Figure 1), the sliding block 210 and the push rod 205 will be in their positions. rearward positions (Figures 1 and 2) and (ii) when the actuator 220 is in its backward position (Figure 9), the sliding block 210 and the push rod 205 will be in their forward positions (Figures 9 and 10). The spring 225 resiliently orients the actuator 220 in its forward position, "and so the sliding block 210 and the push rod 205 in their rearward positions (Figure 1) .If desired, the sliding block 210 can be formed with side slots. 230 (Figures 11 and 13) to be mounted on the lateral rails 105 (Figure 9) formed in the housing 100, whereby the sliding block 210 can be further stabilized as it moves within the housing.

With reference to Figures 1, 2 and 15 to 19, the tool holder assembly 300 comprises a tubular tool holder 305 and a block 310. The proximal end of the tool holder 305 is secured to the block 310, and this block 310 is in turn secured to the housing 100, whereby the tool holder 305 will be secured to the housing 100. An opening 315 in the block 310 communicates between the proximal end surface 317 of the block 310 and the hollow interior of the tool holder 305. The distal end of the tool holder 305 comprises a pair of diametrically opposed slots 320 (Figures 2 and 19) which together define a pair of arms 325. The arms 325 are constructed so that they can be bent outwardly slightly when properly pushed, as will be discussed later in greater detail. Each of the slots 320 has a keyhole type geometry, so that it includes an enlarged opening 330 intermediate in length. The distal end surfaces 335 of the arms 325 are beveled, for reasons that will be discussed below. The tool holder assembly 300 has such a dimension and is positioned so as to receive in a sliding manner the push rod 205. The tool holder assembly 300 also has such a dimension that the push rod 205 extends out of the distal end of the tool holder 205. , regardless of whether the push rod is in its retracted position (Figures 1 and 2) or its projected position (Figures 9 and 10). Looking now to Figures 1, 2 and 20 to 23, the sleeve assembly 400 generally comprises a sleeve 405, a sliding block (or sledge) 410, a pivot arm 415, a locking lever 420 and a spring 425. The proximal end of the sleeve 405 is secured to the sliding block 410, whereby the sleeve 405 will move in unison with the sliding block 410. An opening 430 in the sliding block 410 communicates between the surface of the proximal end of the block 410 and the interior Hollow sleeve 405. This sleeve 405 and the sliding block 410 have such a dimension and are positioned so that they receive and are slidably mounted on the tool holder 305. The pivot arm 415 extends between, and connects pivotally a, the sliding block 410 and the locking lever 420. This locking lever 420 is, in turn, pivotally connected to the housing 100, whereby: (i) when the locking lever 420 is in its downward position (Figure 1), the sliding block 410 and the sleeve 405 will be in your front positions (Figures 1 and 2), where the sleeve 405 will submerge the distal end of the tool holder 305 e (ii) when the locking lever 420 is in its upward position (Figure 3), the sliding block 410 and the sleeve 405 will be in their positions backwards (Figures 3 and 4), where the distal end of the tool holder 305 will project out of the distal end of the sleeve 405. The spring 425 assists in moving the sliding block 410 and the sleeve 405 in their rearward positions, once these Elements begin to move from their front positions (Figure 1) to their backward positions (Figure 3). If desired, the sliding block 410 can be "formed with side grooves 435 (Figures 20 and 22) to be mounted on the corresponding side rails (not shown) formed in the housing 100, whereby the sliding block 210 can be stabilized further as it moves within the housing, looking straight ahead to Figures 1, 2 and 24 to 28, the needle assembly 500 comprises a hollow needle 505, a collar 510 and a fastener 515. The needle 505 is generally curved as length of its length (Figure 2) The specific degree of curvature will depend on the medical procedure that is to be done, thus, it attempts that a particular needle assembly 500 be selected by the user from a set of sets 500 of different needles, available to the user before starting the procedure. The distal end of the needle 505 ends in a sharp tip 520. The proximal end of the needle 505 has a diameter which is substantially the same as the diameter of the tool holder 305. The proximal end of the needle 505 terminates in a pair of tongues 525 diametrically opposed. These tabs 525 have a configuration which is a mirror of the configuration of the slots 320 of the tool holder, for reasons which will be discussed later in greater detail. A slot 530 extends the length of the needle 505 and communicates with the interior of the hollow needle. Preferably the slot 530 extends along substantially the entire length of the needle 505; however, if desired, the slot 530 can be formed in only the distal portion of the needle 505, and the slot 530 can be omitted from the proximal portion of the needle. The collar 510 is mounted on the spout 505. A slot 535 (Figures 24 and 27) is formed on the collar 510. This slot 535 opens on the distal end of the collar 510 and ends intermediate the length of the collar on a surface 540 Preferably, the surface 540 is formed by bending a portion of the upper surface of the collar 510 downward, so as to form a kind of sloping tab 541 (Figure 27). A pair of fingers 545 extend into the groove of the collar 535, on the distal side of the proximal surface 540. The distal ends 550 of the fingers 545 have a beveled configuration. The needle 505 has a dimension to thereby slidably receive a head 555 of the fastener 515 (Figures 27 and 28), while allowing a filament 560 of the fastener to slide slidably through the needle slot 530 and the slot 535 of the collar, with the filament resting on the inclined tongue 541. The collar fingers 545 releasably retain the filament 560, and thus the fastener 515, in place on the needle. More particularly, the fastener 535 is preferably a type H fastener of the kind comprising a first head 515, a second head 565 and a flexible filament 560 of connection (Figure 28). The composition of the fastener 515 will depend on the medical procedure that is executed, for example, for the same applications, the fastener 515 can be formed of polydioxanone, so as to be absorbable or, in some applications, the fastener 515 can be formed of a non-woven material. absorbable, such as polypropylene. Also, the length of filament 560 will also depend on the particular procedure that is performed. It is intended that the proper fastener composition and length will be selected by the user from a set of different sets of pre-loaded needles 500, made available to the user prior to beginning the procedure. The fastener 515 has such a dimension so that its head 555 can be slid along the hollow interior of the needle 505, while the flexible filament 560 of the fastener extends through the slot 530 of the needle. The collar 510 has such a dimension so that the filament 560 of the fastener can slide past the bevelled surfaces 550 of the collar and then be captured, releasably, in the groove of the collar, between the fingers 545 of the collar and the proximal surface 540 of the necklace. Such capture, in a releasable manner, helps to retain the fastener 515 in position on the needle 505 during delivery of the surgical site, and still allows the fasteners to be separated from the needle under an appropriate thrust, as will be discussed later in greater detail. It should also be appreciated that the collar 510 also serves as an appropriate stop to limit the penetration of the needle 505 into the tissue during deployment of the fastener. In addition, the collar 510 also serves to supply compression to the fabric during the fastener placement, in order to ensure good approximation of the edges of the fabric. Looking at Figure 29, the needle assembly 505 is pre-packaged, preferably in a tray 600. The tray 600 comprises a slot 605 for receiving the needle assembly. The distal end of the slot 605 is preferably closed and separated, or otherwise disposed, whereby the sharp tip 520 of the needle 505 will be protected against accidental contact by the user. The proximal end of the slot 605 is preferably opened, or otherwise arranged, whereby the two tabs 525 of the needle will be exposed for contact by the distal end of the tool holder 305, as will be discussed later in greater detail. Preferably, the tray 600 is formed in order to supply the proximal end of the slot 605 with a funnel-like configuration, so as to facilitate the matching of the tool holder 305 with the needle 505. The needle assembly 500 and the tray 600 are pre-packaged, in preferred form, in a sterilized blister pack (ampoule), which can be opened at the time of use.

Once the desired water packing has been selected, the user opens the needle pack using routine aseptic techniques, in order to expose the desired needle assembly 500, which is disposed on its associated tray 600 (Figure 29). Next, the user prepares the applicator 5 to collect the water assembly 500. More particularly, the user takes the applicator 5, which normally has the configuration shown in Figures 1 and 2 (ie, with the actuator 220 out and the locking lever 420 down). The user then prepares the applicator 5 to receive the needle assembly 500, bringing the locking lever 420 upwards (Figures 3 and 4). This causes the sleeve 405 to be retracted to expose the distal point of the tool holder 305. Next, the distal end of the applicator 5 is passed into the end of the funnel of the tray 600 so that the distal end of the applicator makes contact with the end. proximal of needle assembly 500 (Figures 5, 6, 32 and 33). As this occurs, the distal end of the push rod 205 first slides into the hollow interior of the needle, and then the distal end of the tool holder 305 contacts the two tabs 525 of the needle. As shown in Figures 34 and 35, the operation of the applicator 5 will now be described. By way of example, but not limitation, the operation of the applicator 5 will be discussed in the context of using the fastener 515 to close a tear in a piece of meniscal tissue, although many other applications of the present invention will be readily apparent to those skilled in the art. subject matter experts. Looking at Figure 30, the tear 700 at the meniscus 705 is inspected first to determine the appropriate length of the fastener to be used. More particularly, a probe 710 preferably extends through the meniscus and, using the marks 715 (Figure 31) therein, the location and size of the tear is determined. This information is then used to identify the appropriate length of the fastener to be used to effect the desired repair. The user also determines the type of fastener to be used (e.g., of a polydioxanone or polypropylene composition) and the preferred configuration of the water (e.g., the degree of curvature). A pre-packaged 500 needle assembly 500, which meets these certain criteria, is then selected by the user from a class of different sets of previously packed needles.

Initial contact of the beveled surfaces 335 of the tool holder with the tongues 525 of the needle causes the two arms 325 of the tool holder to bend out slightly, so that the tongues 325 can slide into, and settle into, the grooves 320 of type keyhole of the tool holder. Then the locking lever 420 descends again in order to move the distal end of the sleeve 405 forward, over the union of the needle 505 and the tool holder 305 (Figures 7, 8 and 36). This action causes the needle assembly 500 to hold the applicator 5, ensuring that the arms 325 of the holder-holder can not be bent open again, thereby releasing the needle assembly 500. In this aspect, it will be appreciated that: (i) the sleeve 405 is constructed such that an inner diameter, which is just n little larger than the outer diameter of the tool holder 305 and the needle 505; e (ii) the clearance between the tool holder 305 and the tube 405 is such that it is less than the distance required for the tool holder to open, in order to release the needle, and the gap is less than the distance required for the tool The needle moves laterally to separate from the tool holder. At this point, the needle assembly 500 is removed from the tray 600 using the applicator 5.

Next, the distal end of the applicator 5 is advanced through an atroscopic cannula, which has been inserted into the knee. As this happens, the collar 510 helps to hold the fastener 515 in place on the applicator. The distal point of needle 505 is aligned with the area, previously measured, on the meniscus, and then the needle is pushed into meniscus 705 and through tear 700, in the manner shown in Figure 37. Collar 510 acts as a stop to limit the penetration of the needle 505 into the tissue and simultaneously supply the understanding to the meniscus 705 in order to close the tear 700. Then, while maintaining the pressure in the handle of the applicator 5, the user presses the actuator 220 (Figures 9 and 10) so as to cause the push rod 205 to advance. The distal end of the push rod 205 contacts the head 555 of the fastener 515 and expels it out of the distal end of the needle 505. In this regard, it will be appreciated that the flexible construction of the distal end 205A of the push rod 205 , allows this push rod to follow the curvature of needle 505, as the clip is ejected from the needle. As the guide head 555 of the fastener comes out of the side away from the meniscus 705, the pull head 565 of the fastener comes into contact with the proximal side of the meniscus (Figure 38) and urges the closure of the tear 700. Then, the applicator it is removed (Figure 39) in order to push the distal tip of the needle 505 from the meniscus 705, thus leaving the fastener 515 in place, so as to keep the tear 700 closed (Figure 40). Then, the needle 505 (without the fastener 515) can be inserted back into its associated tray 600, the raised locking lever 420 to thereby retract the distal end of the sleeve 405 and release the needle 505, and then the needle is removed of the tool holder 305, and the tray 600 and the needle 505 can be discarded in the traditional way in the so-called "sharp objects" container. Modifications of the Preferred Modality It is, of course, possible to modify the preferred embodiment discussed above, without departing from the scope of the present invention. Thus, for example, it is possible to use the present invention in another method of that described above, for example, one can use the present invention to join two pieces of tissue in the chest or abdomen. Or one may form the needle assembly 500, so that it incorporates a straight needle 505A (Figure 41) rather than the curved needle 505, discussed above. Of course, in such a situation, the configuration of the tray 600 can also be changed, as shown in Figure 42. Likewise, in such a situation, the distal end 205A of the push rod 205 can be formed to be relatively rigid, since it does not need to cross a curved arch as in the case where a curved needle is used. Or it is possible to use the present invention with a T-type fastener 515A of the kind shown in Figure 43, rather than with the H-type fastener 515, described above. Or the distal end 205A of the push rod 205 can be formed of a flexible plastic, rather than as a flexible spring. Also, it is possible to vary the configuration of the slots 320 of the tool holder and the tabs 525 of the needle, for example, they can be formed in the manner of the slot 320A and the tab 525A shown in Figure 44, or the slot 320B and the tab 525B shown in Figure 45, or the slot 320C and the tab 525B shown in Figure 46. Still other configurations of slots and tabs will be obvious to a person skilled in the art applying the teachings of the present invention. In essence, the slots 320 and the tabs 525 may have many different configurations, as long as (i) the slots 320 and 525 are mirror configurations and (ii) the tabs 525 have an enlargement towards their distal end, which is received in a corresponding enlarged offset of the distal end of the tool holder 305. Similarly, while in the above discussion, the slots 320 have been described and illustrated as being formed in the tool holder 305, and the tabs 525 have been described and illustrated as being formed on the needle 505, its arrangements can be reversed, i.e., the slots 320 can be formed in the needle 505 and the tabs 525 can be formed in the tool holder 305. Also, the collar 510 can be omitted from the needle assembly 500, if is desired Still other changes of this type will be obvious to a person skilled in the art and are considered to be within the scope of the present invention.

Claims (18)

1. CLAIMS 1. An applicator for deploying a fastener within a fabric, this fastener includes a head portion and a filament portion, extending from the head portion, the applicator comprising: an elongated, hollow, needle element, having an "acute distal end portion, a slotted portion, for releasably retaining the configured fastener head, and a first connector portion, and a tool holder, comprising a second connector portion, which can be coupling with the first connector portion, for interconnecting the needle element and the tool holder, a push rod, having a distal end portion adapted to move longitudinally within the needle element, and an actuator for moving the push rod within of the water element, so as to eject the head portion of the fastener from the slotted portion of the needle element.
2. 2. An applicator, according to the claim 1, in which the hollow needle element is curved, and the distal end portion of the push rod is sufficiently flexible to move longitudinally within the needle element.
3. 3. An applicator, according to claim 1, in which this applicator further comprises a sleeve element, movable axially about a distal portion of the tool holder, and a proximal portion of the needle element, so as to encircle the first and second one. connector portions and locking these connector portions together, in order to prevent their inadvertent separation.
4. 4. An applicator, according to claim 3, wherein the sleeve element can be removed from the connector portions, so as to allow separation of these connector portions mutually. An applicator, according to claim 4, wherein the applicator is provided with a lever connected to the sleeve, and the lever can be manipulated to thereby cause the sleeve to selectively circumvent the connector portions and withdraw from these portions of the sleeve. connector An applicator, according to claim 1, in which the push rod actuator comprises a trigger connected to the push rod, and this trigger can be manipulated against the spring orientation, to move this push rod. 7. An applicator, according to claim 1, wherein the distal end portion of the push rod comprises a flexible spring, which is substantially incompressible. 8. An applicator, according to the claim 1, in which "the second connector portion comprises leg portions, which have opposite recesses, and the first connector portion comprises a tongue having at its free end an enlarged portion, configured in complementarity with respect to the recesses, these portions of The legs are sufficiently resilient to allow the tongue to be inserted between them, and the enlarged portion to insert the recesses. 9. An applicator, according to claim 8, in which this applicator further comprises a sleeve element, arranged around the tool holder and axially movable from this tool holder, so as to encircle the first and second connector portions and thus lock these portions of connector mutually. 10. An applicator, according to claim 9, in which the push rod is disposed within the tool holder and can move axially of the tool holder, in order to expel the head portion of the holder. 11. An applicator, according to claim 8, in which the needle comprises two tongues, diametrically opposed, which are received by the tool holder. 12. An applicator, according to claim 5, wherein the sleeve is spring oriented in a direction proximally from the connector portions. 13. An applicator, according to claim 2, wherein the distal end portion of the push rod is formed of a compound selected from metal, plastic and combinations thereof. 14. An applicator, according to claim 1, wherein the applicator further comprises a collar mounted on the needle element, for releasably holding the filament portion of the fastener to the needle element. 15. An applicator, according to claim 14, wherein the collar is arranged to be brought into contact and brought against the tissue when the needle element is inserted into the tissue. 16. A method for deploying a fastener within a mammalian tether, this method comprises the steps of: placing a head portion of the fastener inside a slotted portion of the hollow needle element, - attaching the needle element to a tool holder, which extends from a tool; manipulating the tool to slide a sleeve over a joint of the needle element and the tool holder, in order to lock the needle element in the tool holder; advancing the needle element within the body to a point where the slotted portion of this needle element is adjacent to an area in which the fastener is positioned; and manipulating the tool to move a push rod centrally of the tool holder, thereby engaging the clip and ejecting the head portion of the clip from the slotted portion of the needle element. 17. One method, according to the claim 16, which comprises the additional step of removing the needle element from the tool holder. 18. A method, according to claim 16, which comprises the additional steps of manipulating the tool, in order to remove the sleeve from the joint of the needle element and the tool holder, disconnect the needle element from the tool holder and discard this needle element .