BR112018002649B1 - SURGICAL INSTRUMENT - Google Patents

Abstract

SURGICAL INSTRUMENT WITH A STOP PROTECTOR. Surgical instruments and methods, which include a stop guard, are described in the present invention. An exemplary instrument may include an internal drive shaft disposed within an external drive shaft, the internal drive shaft including a tissue piercing tip and being effective for securing an end actuator to the device. A stop guard may be coupled to the inner drive shaft and extend through the outer sidewall openings of the drive shaft when the tip is advanced distally or retract into the outer drive shaft when the tip is retracted proximally. In a percutaneous procedure, the external force applied to the stop guard by tissue can retract the tip to prevent damage to the surrounding tissue as the instrument is advanced distally. Additionally, as it passes through the perforated tissue, the stop guard can be repositioned when the internal drive shaft is advanced distally to protect an instrument end actuator and can prevent inadvertent withdrawal of the instrument.

Description

FIELD OF INVENTION

[001] The present invention relates, generally, to surgical instruments and, more particularly, to such instruments that include a stop protector to prevent overinsertion and inadvertent removal from a patient's body.

BACKGROUND

[002] Surgical procedures are used to treat and cure a wide range of diseases, conditions and injuries. Surgery usually requires access to internal tissue through minimally invasive or open surgical procedures. The term "minimally invasive" refers to all types of minimally invasive surgical procedures, including endoscopic, laparoscopic, arthroscopic, intraluminal through natural orifices, and transluminal through natural orifices procedures.

[003] Minimally invasive surgery can have numerous advantages compared to traditional open surgery, including reduced recovery time, pain and surgery-related complications. In many minimally invasive procedures, the abdominal cavity is insufflated with carbon dioxide gas to provide adequate space to perform the procedure. The inflated cavity is generally under pressure and is sometimes referred to as being in a state of pneumoperitoneum. Surgical access devices are often used to facilitate surgical manipulation of internal tissue while maintaining pneumoperitoneum. For example, during a surgical procedure, the abdominal wall may be punctured and a cannula or trocar may be inserted into the abdominal cavity. Surgeons can then perform a variety of procedures, minimizing patient trauma.

[004] Various surgical instruments can be configured to manipulate tissue during a minimally invasive surgical procedure. An exemplary surgical instrument may include an actuator and an elongated drive shaft with an end actuator that may be selectively coupled to the drive shaft and may pivot with respect to the drive shaft. Such a device may include one or more modular features, such as an end actuator that can be selectively fixed and separated from the drive shaft using a locking mechanism. The device may also include an internal drive shaft disposed within the elongated drive shaft, and the internal drive shaft may include a sharp tip for piercing the abdominal wall. Consequently, the device can be inserted into a patient's body without a fixed end actuator by using the sharp tip of the internal drive shaft to form an incision in the tissue. The end actuator can then be selectively attached to the patient within, for example, the abdominal cavity, to perform the procedure.

[005] Although the sharp tip of the instrument can be useful for piercing the abdominal wall, it can cause damage to the surrounding tissue if the instrument is inserted too deeply into the patient's body. Even if the instrument is not overinserted distally, movement of the sharp tip around the body can cause undesirable damage to nearby tissue. Furthermore, it is also possible that a user could easily remove the surgical device from the patient's body inadvertently, both when an end actuator is attached to it and especially when no end actuator is attached due to the low profile of the shaft. elongated drive by itself.

[006] Additionally, surgical devices configured to selectively couple end actuators within the body may sometimes employ a shackle-like attachment mechanism that includes opposing arms that are radially deflectable to permit insertion into a socket formed in a end actuator. The opposing arms of the clamping mechanism may, in some embodiments, be quite small and thin. There is a risk of these arms becoming permanently curved or otherwise deformed if, for example, an end actuator is not correctly aligned during coupling (e.g. if only one of the arms enters the socket on the end actuator while the other arm remains outside of the socket, the arms may curve away from each other). It is also possible that tissue or other nearby structures could catch one of the arms during device insertion and/or removal.

[007] Consequently, there is a need for improved devices and methods that help users avoid overinsertion and/or involuntary withdrawal of a device passing through tissue. There is also a need for devices and methods that protect against damage to a fastening mechanism used for coupling to an end actuator.

SUMMARY OF THE INVENTION

[008] The present invention generally provides devices and surgical methods that prevent overinsertion and/or involuntary withdrawal of an instrument that passes percutaneously through tissue, while also providing protection to any more delicate components of the device, such as a mechanism for fixation. The instruments described herein generally include a selectively positionable stop guard coupled to a sharp distal tip of the instrument. The stop guard can be configured to position when the sharp distal tip is exposed to pierce tissue. As the distal tip advances through tissue, the positioned stop guard may contact the tissue being pierced and move to a retracted configuration in response to a force exerted on the stop guard by the tissue. This movement can cause the distal tip attached to the stop guard to also move into a retracted position, preventing any unwanted damage to nearby tissue. Additionally, once the stop guard advances through the tissue in the retracted configuration, it can again be positioned and used selectively to provide increased resistance for removal of the instrument from the patient's body.

[009] The instruments described here may also include features that protect against damage to a clamping mechanism used to couple a distal end of the instrument to an end actuator. Such components may include, for example, a protective sheath that may selectively surround a distal portion of the device, as well as a snap ring or other retention device that may provide support for, for example, opposing arms of a fastening mechanism similar to shackle.

[010] In one aspect, a surgical instrument is provided that includes an external drive shaft with an internal lumen and at least one side wall opening formed therein. The instrument may additionally include an internal drive shaft disposed within the internal lumen of the external drive shaft and configured to translate relative to the external drive shaft along a longitudinal drive axis thereof. The internal drive shaft may also include a distal end configured to pierce tissue. The instrument may also include a stop guard coupled to the inner drive shaft and having at least one retractable tab configured for both radially outward extension through the at least one outer drive shaft side wall opening and radially inward retraction into towards the inner drive shaft, so that the retractable flap is arranged within one diameter of the outer drive shaft. Furthermore, when the at least one retractable tab extends radially outwardly through the at least one side wall opening of the external drive shaft, the at least one retractable tab can be configured to retract radially inwardly toward the drive shaft. internal actuation in response to at least one retractable flap contacting an external object as the instrument advances distally into the tissue. Furthermore, radially inward retraction of the at least one retractable tab may result in the distal end of the inner drive shaft retracting proximally toward the distal end of the outer drive shaft.

[011] The devices and methods described herein may have a number of additional features and/or variations, all of which are within the scope of the present disclosure. In some embodiments, for example, the distal end of the internal drive shaft may be configured to retract proximally toward the distal end of the external drive shaft so that upon contact with an external object by at least one retractable tab , the distal end of the internal drive shaft is disposed within the inner lumen of the external drive shaft.

[012] In other embodiments, the instrument may additionally include an intermediate drive shaft with an internal lumen and at least one side wall opening formed therein. The intermediate drive shaft may be disposed between the outer drive shaft and the inner drive shaft and may be configured to translate relative to the outer drive shaft along a longitudinal drive axis thereof. The intermediate drive shaft may further be configured to translate to a position in which the at least one open side wall of the intermediate drive shaft is aligned along at least a portion of its length with the at least one side wall opening of the intermediate drive shaft. external drive shaft and a distal end of the intermediate drive shaft extends distally beyond the distal end of the external drive shaft. In such an embodiment, the distal end of the internal drive shaft may be configured to retract proximally toward the distal end of the intermediate drive shaft, upon contact with an external object by at least one retractable tab, so that the distal end of the internal drive shaft is arranged within the internal lumen of the intermediate drive shaft.

[013] In certain embodiments, each of the intermediate and external drive shafts may include a first and second deflectable arms. The deflectable arms may be extended radially outwardly by the inner drive shaft moving distally between them, and the radial extension of the arms may attach an end actuator to a distal end of, for example, the intermediate and/or outer drive shafts. . According to some embodiments, the instrument may include an end actuator configured to be coupled to at least one of the distal end of the intermediate drive shaft and the distal end of the outer drive shaft by the inner drive shaft extending the first and the second deflectable arms of the intermediate drive shaft and/or the outer drive shaft radially outward toward the side walls of the end actuator. Furthermore, in some embodiments, the at least one retractable flap of the stop guard may be configured to extend radially outwardly through the at least one sidewall opening of the external drive shaft when the end actuator is coupled to at least one of the distal end of the intermediate drive shaft and the distal end of the outer drive shaft.

[014] In embodiments that include an intermediate drive shaft, the stop protector may have a completely retracted position in which the outermost radius of the stop protector is greater than a radius of the intermediate drive shaft, but less than a radius of the external drive shaft.

[015] The jamb protector can have a variety of shapes and configurations. In some embodiments, for example, the at least one retractable flap of the jamb protector may include a first retractable flap and a second retractable flap, the first and second retractable flaps being configured to extend radially outwardly through the first and second retractable flaps. sidewall openings of the at least one sidewall opening of the outer drive shaft, respectively, and retract radially inwardly toward the inner drive shaft so that the first and second retractable flaps are disposed within a diameter of the external drive shaft. In some embodiments, for example, the first and second retractable flaps may be disposed on opposite sides of the internal drive shaft from each other. In other embodiments, however, a different number of retractable flaps may be used, and the flaps may be positioned differently on the instrument.

[016] In another aspect, a surgical instrument is provided that may include an external drive shaft having an internal lumen and at least one side wall opening formed therein, as well as an internal drive shaft disposed within the lumen. internal shaft of the external drive shaft and configured to translate with respect to the external drive shaft along the axis of a longitudinal drive shaft thereof. The internal drive shaft also includes a distal end configured to pierce tissue. The instrument further includes a stop guard coupled to the internal drive shaft and configured to proximally retract the internal drive shaft upon tissue contact such that the distal end of the internal drive shaft is contained within the inner lumen of the shaft. external drive. Accordingly, the stop guard can realize automatic retraction of the distal tissue piercing tip of the internal drive shaft with a predetermined insertion depth, for example, as the instrument passes through tissue, such as in the wall of the abdomen. Furthermore, retraction can be accomplished through interaction between the stop protector and tissue (e.g., an abdominal wall).

[017] As with the instrument described above, a number of variations and additional features are possible. For example, the stop guard may be further configured to move between a first position in which the stop guard extends through the at least one side wall opening when the distal end of the internal drive shaft extends distally beyond a distal end of the outer drive shaft, and a second position in which the stop guard is retracted toward the inner drive shaft such that a radius of the stop guard is smaller than a radius of the outer drive shaft when the distal end of the external drive shaft is disposed within the internal lumen of the external drive shaft.

[018] In other embodiments, the instrument may include an intermediate drive shaft with an internal lumen and at least one side wall opening formed therein, the intermediate drive shaft being disposed between the external drive shaft and the shaft. internal drive axis and configured to translate relative to the external drive axis along a longitudinal drive axis thereof. The intermediate drive shaft may further be configured to translate to a position in which the at least one sidewall opening of the intermediate drive shaft is aligned along at least a portion of its length with the at least one sidewall opening. of the external drive shaft and a distal end of the intermediate drive shaft extends distally beyond the distal end of the external drive shaft.

[019] In certain embodiments, each of the intermediate and external drive shafts may include a first and second deflectable arms. In such embodiments, the retractable stop guard may be configured to move to a third position, in which the stop guard extends through the at least one side wall opening of both the intermediate drive shaft and the outer drive shaft. and the distal end of the inner drive shaft is disposed at or distal to the distal end of the intermediate drive shaft to cause the first and second deflectable arms of the intermediate drive shaft to extend radially outwardly toward the side walls of an end actuator for coupling the end actuator to at least one of the intermediate drive shaft and the outer drive shaft.

[020] In another aspect, a method for piercing tissue is provided that includes passing an internal drive shaft of an instrument distally through a lumen of an external drive shaft of the instrument, such that a distal end of the shaft The inner drive shaft extends beyond a distal end of the outer drive shaft and a stop guard coupled to the inner drive shaft extends radially outward from the outer drive shaft. The method may further include forming a perforation in the tissue by advancing a distal end of the internal drive shaft into the tissue. The method may also include advancing the instrument through the perforation until the guard shield coupled to the inner drive shaft and extending radially outward from the outer drive shaft contacts the tissue in which the perforation was formed, thereby making causing the stop guard to retract radially inward toward the inner drive shaft and the distal end of the inner drive shaft to retract proximally toward the distal end of the outer drive shaft. In some embodiments, the distal end of the internal drive shaft may retract proximally into the lumen of the external drive shaft in response to the stop guard retracting radially inward toward the internal drive shaft.

[021] In other embodiments, the method may further include advancing the instrument through the perforation when the stop guard is retracted radially inwardly so that the stop guard passes through the perforation, and coupling an end actuator to the external drive shaft by advancing the distal end of the internal drive shaft distally through the lumen of the external drive shaft so that the stop guard moves from its radially retracted inward position to extend radially outward from the drive shaft external.

[022] In certain embodiments, an intermediate drive shaft with an internal lumen may be disposed between the external drive shaft and the internal drive shaft and may be positioned so that a distal end of the intermediate drive shaft extends distally beyond from the distal end of the external drive shaft. Furthermore, passing the internal drive shaft of the instrument distally through the lumen of the external drive shaft may also include passing the internal drive shaft distally such that the distal end of the internal drive shaft extends beyond an end distal to the intermediate drive shaft.

[023] In still other embodiments, the method may further include advancing the instrument through the perforation when the stop guard is retracted radially inwardly, such that the stop guard passes through the perforation. The method may also include coupling an end actuator to at least one of the intermediate drive shaft and the external drive shaft, advancing the distal end of the inner drive shaft distally through the lumen of the intermediate drive shaft so that the stop guard moves from its radially retracted inward position to extend radially outward from the intermediate drive shaft.

[024] Any of the features or variations described above can be applied to any particular aspect or embodiment of the invention in several different combinations. The absence of explicit recitation of any particular combination is due solely to the avoidance of repetition in this summary.

BRIEF DESCRIPTION OF THE DRAWINGS

[025] Figure 1 is a perspective view of an embodiment of a surgical instrument with a stop protector;

[026] Figure 2 is a detailed view of a distal end of the instrument of Figure 1;

[027] Figure 3 is a perspective view of an internal drive shaft of the instrument of Figure 1;

[028] Figure 4 is a detailed view of an actuator of the instrument of Figure 1;

[029] Figure 5A is a side view of an embodiment of a surgical instrument that has a stop guard that advances through the tissue;

[030] Figure 5B is a side view of the instrument of Figure 5A in contact with tissue that causes the stop protector to retract radially inwardly and an obturator to retract proximally;

[031] Figure 5C is a perspective view of an internal drive shaft of the instrument of Figure 5A with the stop protector retracting radially inwardly;

[032] Figure 6A is a side view of an embodiment of a surgical instrument and a loading device before coupling an end actuator to the surgical instrument;

[033] Figure 6B is a detailed view of the instrument and loading device of Figure 6A, including a distal coupling feature of the instrument being positioned adjacent to, and in axial alignment with, the loading device;

[034] Figure 6C is a detailed view of the instrument and the loading device of Figure 6A, including coupling the instrument to an end actuator maintained by the loading device;

[035] Figure 6D is a side view of the instrument and the loading device of Figure 6A, including the instrument and the end actuator coupled thereto, moving away from the loading device;

[036] Figure 7A is a perspective view of an embodiment of a surgical instrument including a wound protector in a distal position;

[037] Figure 7B is a perspective view of the surgical instrument of Figure 7A with the wound protector in a proximal position;

[038] Figure 7C is a detailed view of a distal end of the instrument of Figure 7A;

[039] Figure 7D is a side cross-sectional view of a distal end of the instrument of Figure 7A; It is

[040] Figure 8 is a perspective view of an embodiment of a surgical instrument including a clamp with support spring.

DETAILED DESCRIPTION OF THE INVENTION

[041] Certain exemplary embodiments will now be described to provide a general understanding of the principles of structure, function, manufacture and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the attached drawings. Those skilled in the art will understand that the devices and methods specifically described in the present invention and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the present invention is defined only by the embodiments. Features illustrated or described in relation to an exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[042] Additionally, to the extent that linear or circular measurements are used in describing the devices and methods presented, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such devices and methods. One skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Furthermore, in the present disclosure, the similarly numbered components of the embodiments generally have similar characteristics. Still further, the sizes and shapes of the devices, and the components thereof, may depend at least on the anatomy of the individual on whom the devices will be used, the size and shape of the components with which the devices will be used, and the methods and procedures where the devices will be used.

[043] Surgical devices and methods will be described herein, which include features to prevent accidental overinsertion and/or removal of a device that is passed percutaneously into a patient's body. Such devices generally may include an actuator and an elongated drive shaft that may extend from the actuator, and a distal end of the drive shaft may be configured to selectively couple to an in vivo or ex vivo end actuator. The elongated drive shaft may itself include an outer drive shaft, an intermediate drive shaft, and an inner drive shaft with a selectively positionable stop guard coupled thereto, as explained in more detail below. In an exemplary embodiment, a device or instrument for performing a surgical procedure may be provided which includes an internal drive shaft or obturator with a sharp distal tip configured to pierce tissue and a selectively positionable stop guard configured to avoid damage to surrounding tissue as a result of overinsertion of the distal tip. Additionally, the stop guard may be configured to proximally retract the internal drive shaft in contact with tissue (e.g., the tissue being penetrated by the instrument) so that the tissue-piercing distal end of the internal drive shaft is safely contained within the external drive shaft. Still further, the stop guard can be used to prevent accidental withdrawal of the instrument once positioned inside a patient's body, for example, by passing the stop guard through the tissue in a retracted configuration and positioning it inside the patient's body. abdominal cavity or other area of a patient's body. The stop guard may have several different configurations but, in some embodiments, may include two (or some other number of) tabs (or other structures) formed on the internal drive shaft that may be extended radially when the sharp distal tip is exposed to from a distal end of the external and/or intermediate drive shafts.

[044] In use, this instrument can be inserted into a patient's body using the sharp tip on the obturator to pierce and penetrate through tissue. Exemplary tissue may include, for example, the patient's abdominal wall. However, this is just one example of tissue that can be penetrated, and the instrument can also be used in combination with any other tissue found in other areas of the body or with other "non-woven" objects. The stop guard, which can be extended or positioned when the sharp distal tip is exposed, can come into contact with an external object such as the tissue being pierced and prevent the sharp distal tip from extending further into the tissue where it is inserted. may cause unwanted damage. Additionally, a force exerted on the stop guard by fabric or another external object may cause the stop guard and obturator to retract proximally. This proximal movement may shield the distal tip of the obturator within the intermediate and/or external drive shafts and may cause the stop guard to retract radially inward. In some embodiments, the device may then be further inserted into the tissue such that the stop guard, in its retracted state, is positioned on a side away from the punctured tissue in a patient's body. The stop protector can then be selectively positioned again, for example in connection with coupling an end actuator to a distal end of the intermediate and/or external drive shafts. By way of further example, in some embodiments, the plug or internal drive shaft having a sharp distal tip may also be used to lock an end actuator to a distal end of the intermediate and/or external drive shafts. As a result, when an end actuator is attached to the instrument inside a patient's body, the obturator can advance distally to secure the connection. Distal advancement of the obturator relative to the intermediate and/or external drive shafts may result in positioning of the stop guard within the abdominal cavity or other area of the body. Positioning the stop guard inside a patient's body can thus prevent inadvertent removal of the instrument from the body.

[045] Figures 1 to 4 illustrate an embodiment of a device or surgical instrument that includes a stop protector capable of selective positioning. The device 20 may generally include an actuator 10 and an elongated drive shaft 12 that may pierce the tissue, pass through an incision formed in the tissue, and couple to an end actuator (see Figure 6D). The elongated drive shaft 12 may itself include an external drive shaft 14, an internal drive shaft or plug 32, and an intermediate drive shaft 35. As shown in Figure 2, the inner drive shaft 32 may include a tip. sharp distal 33 that can be configured to pierce tissue. A stop guard 50, such as one or more tabs 50a, 50b, may be coupled to the inner drive shaft 32 and may be configured to selectively position the outer drive shaft 14 to serve as an insertion depth stop when the device is advanced distally, as well as a withdrawal stop when the device is retracted proximally. When extending the flaps 50a, 50b of the external drive shaft 14, the flaps may come into contact with the tissue being penetrated and a force exerted on the flaps by the tissue may cause proximal retraction of the internal drive shaft 32 relative to the shaft. of the external drive shaft 14, thus avoiding over-insertion of a sharp distal tip 33 of the internal drive shaft 32. Furthermore, if the stop guard 50 is positioned within the body of a patient, for example, in connection with the coupling an end actuator (see Figure 6D) to the device 20, the tabs 50a, 50b can prevent inadvertent withdrawal of the device from a body cavity. The flaps 50a, 50b of the stop guard 50 can be selectively positioned through the side wall openings 15a, 15b formed in the outer drive shaft 14 and the intermediate drive shaft 35. As illustrated in the figures, the side wall openings 15a, 15b may be formed opposite each other in some embodiments (to correspond to the placement of the flaps 50a, 50b) and may be of a length that allows for distal and proximal movement of the flaps that are coupled to the internal drive shaft 32.

[046] The actuator 10 may include a button 36 configured to rotate the elongated drive shaft 12 (and its constituent components) about a longitudinal drive axis z thereof, which may also result in rotation of any end actuator coupled to it. The actuator 10 may additionally include a closing actuator, such as a pivot trigger 38, which is configured to move relative to the actuator 10 to actuate an end actuator (e.g., claws) coupled to the drive shaft. This can be accomplished, for example, by coupling the pivot trigger 38 to the intermediate drive shaft 35, so that movement of the pivot trigger can cause proximal or distal movement of the intermediate drive shaft 35 relative to the external drive shaft 14 Additionally, an internal drive shaft actuator 40, such as a button or slider, may be configured to control the proximal/distal movement of the internal drive shaft or plug 32 relative to the external drive shaft 14. The actuator 10 may also include a latch 72 that may lock the internal drive shaft 32 in a distally advanced position. The internal actuation components that translate movement from one component, e.g., the pivot trigger 38, to another, e.g., the intermediate drive shaft 35, are known to those skilled in the art, therefore, the exact details about each one of these components are unnecessary (although some additional, non-limiting discussion of the same is provided below in relation to Figure 4). One skilled in the art will recognize that the components associated with the various features of the actuator 10 may be mechanical, electrical and/or optical based, and may include various actuators, gears, levers, triggers and sliding elements.

[047] A distal end 16 of the elongate drive shaft 12 may include a clamping mechanism 18 that may be configured to couple the external drive shaft 14 and/or the intermediate drive shaft 35 with a variety of end actuators ( for example, see Figure 6D). In some embodiments, for example, the external drive shaft 14 and/or the intermediate drive shaft 35 may form a shackle-like clamping mechanism 18 that includes opposing arms 24a, 24b of the external drive shaft 14 and/or opposing arms. 25a, 25b of the intermediate drive shaft 35. Each of the arms 24a, 24b and 25a, 25b may be radially deflectable to accommodate interfacing with a socket formed in an end actuator, as explained in more detail below. Proximal or distal movement of the internal drive shaft 32 can effectively lock the clamping mechanism 18 because when the internal drive shaft 32 is advanced distally (e.g., as shown in Figure 2), it can occupy the space between the arms opposite 24a, 24b and/or 25a, 25b, thus avoiding any radial deflection into it. Conversely, when retracted proximally (e.g., as shown in Figure 7C), a gap is present between opposing arms 24a, 24b and/or 25a, 25b, which may allow inward radial deflection of the arms one toward to the other.

[048] Figure 2 illustrates a detailed view of the clamping mechanism 18 located at the distal end 16 of the elongated drive shaft 12. The clamping mechanism 18 may include a coupling feature, such as a circumferential groove 21 located on a side surface of the external drive shaft arms 24a, 24b, which can accommodate a corresponding feature formed in a side wall of an end actuator. As mentioned above, the outer drive shaft arms 24a, 24b may be resiliently flexible and may include an opening between them to allow inward radial deflection of one toward the other. The attachment mechanism 18 may also include intermediate drive shaft arms 25a, 25b disposed at the distal end of the intermediate drive shaft 35 and projecting distally from the distal ends of the external drive shaft arms 24a, 24b. The intermediate drive shaft 35, including the arms 25a, 25b, may be axially sliding with respect to the outer drive shaft 14, as described above, and may similarly be resiliently deflectable, that is, flexibly tensioned, medially ( i.e., radially inward) to a gap between the opposing arms. The intermediate drive shaft arms 25a, 25b may also include one or more mating features, such as stepped side notches 26a, 26b, which may be configured to accommodate mating features formed in a socket side wall of an end actuator to couple the end actuator to the device 20. The internal drive shaft 32 may be positioned medially with respect to the intermediate drive shaft arms 25a, 25b and/or the external drive shaft arms 24a, 24b so that the internal drive shaft is disposed within an internal lumen of the external drive shaft and/or the intermediate drive shaft.

[049] As mentioned above, the internal drive shaft can be slid axially in relation to the arms 24a, 24b, 25a, 25b between a first position, in which the internal drive shaft is extended distally and medial deflection of the arms is avoided. (as shown in Figure 2) and an unlocked position, in which the internal drive shaft is retracted proximally and medial deflection of the arms is allowed (as shown in Figure 7C). The inner drive shaft 32 and the intermediate drive shaft arms 25a, 25b can slide independently relative to the outer drive shaft 14 and its outer drive shaft arms 24a, 24b. Additionally, the distal ends of the intermediate drive shaft arms 25a, 25b and the distal ends of the external drive shaft arms 24a, 24b may include tapered distal facing surfaces to facilitate passage through an incision and/or the coupling with an end actuator. An end actuator may be coupled to the distal end of the device 20 in vivo or ex vivo. The end actuator can be coupled in a variety of ways, for example, using a loading device as described below. In such embodiments, the charging device may contain an end actuator for attachment to the distal end of the device. Use of this device is only one possible method for associating an end actuator with device 20, however, there are several other possible methods as well. More information about the operation of a mechanism similar to clamping mechanism 18 can be found in US Patent publication no. 2011/0087267, entitled "Method for Exchanging End Effectors In Vivo" which is incorporated herein by reference in its entirety.

[050] The internal drive shaft 32, intermediate drive shaft 35 and the external drive shaft 14 can be made in a variety of shapes and sizes and can be made from a variety of materials, depending, at least in part, on of the procedure being performed, the size and type of incisions and ports being used, and other instruments, devices, and extremity actuators with which the device is being used. Preferred materials for forming the drive shafts may allow the drive shafts to have a degree of flexibility, and may include a variety of materials known to one of skill in the art. Drive shafts are shown to be generally cylindrical, although they can take the form of various other shapes. Although the sizes of drive shafts, such as their diameter and length, may depend on the other components with which they are used and the procedure in which they are used, generally a diameter of the external drive shaft 14 may be in a range of about 1 millimeter to about 10 millimeters, and in one embodiment, the diameter may be about 3 millimeters, and generally, a length of the external drive shaft 14 may be in a range of about 50 millimeters to about 300 millimeters, more specifically in a range of about 200 millimeters to about 300 millimeters and, in one embodiment, the length may be about 230 millimeters. The sizes of the intermediate drive shaft 35 and the inner drive shaft 32 may be varied suitably to interact with the outer drive shaft 14 in the manner described herein.

[051] As shown in Figure 3, the internal drive shaft 32 may include a sharp distal tip 33. The internal drive shaft 32 may be used to form perforations in the tissue and may additionally be used to lock an end actuator onto the end. distal of the device 20. The internal drive shaft 32 may also have a stop protector 50 coupled thereto. The stop guard 50 may allow the sharp tip 33 to pierce tissue, but prevents the sharp tip of the internal drive shaft 32 from advancing distally beyond the desired amount, which could possibly cause unintended damage to the surrounding tissue. The stop guard 50 may have a variety of configurations and, in some embodiments, may include at least one retractable flap configured to extend radially outwardly through a sidewall opening of the outer drive shaft and/or the drive shaft. intermediate and retract radially inward toward the inner drive shaft so that the retractable tab is disposed within one diameter of the outer drive shaft. In one embodiment, the jamb protector 50 may include two retractable flaps 50a, 50b. Flaps 50a, 50b may be arranged on opposite sides of the internal drive shaft 32 from each other. Tabs 50a, 50b of stop guard 50 may be configured to extend radially outwardly through sidewall openings 15a, 15b of the external drive shaft (see Figure 5C). The stop guard 50 may have a completely retracted position in which an outermost radius of the stop guard 50 is greater than a radius of the intermediate drive shaft 35 but less than a radius of the outer drive shaft 14.

[052] In one embodiment, the stop protector 50 can be tilted, forming an acute angle with a longitudinal drive axis y of the internal drive shaft 32 in a direction facing the distal direction. The flaps 50a, 50b may have a proximally or externally inclined surface 52a, 52b that forms an acute angle with the longitudinal drive axis y of the drive shaft 32 when viewed from the distal end of the drive shaft. Additionally, the flaps 50a, 50b may include a distal coating surface 53a, 53b that may contact an external object, such as a tissue surface being penetrated, when the internal drive shaft 32 is advanced distally. The stop guard 50 may be coupled to the internal drive shaft 32 at a particular distance from the sharp distal tip 33. In one embodiment, the stop guard 50 may be positioned at a distance from the distal tip 33 that is approximately equal to the thickness of the tissue to be punctured (e.g. the thickness of the abdominal wall).

[053] Figure 4 illustrates an embodiment of the actuator 10 that can be used with the instrument 20. The actuator 10 can include a base 31 and a button 36. The button 36 can rotate the clamping mechanism 18 disposed at the distal end 16 of the elongated drive shaft 12 about a longitudinal drive axis z of the elongated drive shaft 12 which, in turn, can rotate a fixed end actuator (not shown). The trigger 38 may pivot relative to the base 31 to cause axial movement of the intermediate drive shaft 35 relative to the external drive shaft 14. In one embodiment, this motion may be transferred to the end actuator to control opening. and closing the jaws of a fixed end actuator (not shown). In other embodiments, however, this movement may be transferred to another actuation of an end actuator (e.g., in cases where the end actuator does not include movable claws). A button 40, or other drive mechanism, may control the axial movement of the inner drive shaft 32 relative to the outer drive shaft 14 and the intermediate drive shaft 35. For example, pressing the button 40 relative to the base 31 the internal drive shaft 32 may be advanced distally to the position shown in Figure 2, which may also result in the flaps 50a, 50b of the stop guard 50 extending radially outwardly through the side wall openings 15a, 15b. On the other hand, releasing the button 40 may retract the internal drive shaft 32 proximally to the position shown in Figure 7C, which may also result in the flaps 50a, 50b of the stop guard 50 retracting radially inwardly onto the drive shaft. external drive shaft 14. The latch 72 may include a button which, when pressed toward the base 31, may maintain the internal drive shaft 32 in a distally extended and locked position where the tabs are radially extended away from the external drive shaft 14. An additional button 60 can release the elongated drive shaft 12 from the actuator 10 so that its various components (e.g., external drive shaft 14, internal drive shaft 32, intermediate drive shaft 35) can be removed, replaced , clean, etc. More information about the actuator 10 can be found in US patent application no. 14/836069 (Atty. Dkt. No. 100873-716 (END7718USNP)), filed on August 26, 2015 and entitled "Surgical Device Having Actuator Biasing and Locking Features", which is incorporated herein by reference in its entirety.

[054] Figures 5A to 5C illustrate an exemplary method for perforating fabric using a device including a stop protector. The method may include advancing the sharp distal tip 33 of the internal drive shaft 32, when in the configuration shown in Figure 2, distally into the tissue to pierce it. When the internal drive shaft 32 is advanced distally, the arms 25a, 25b, 24a, 24b can be locked against radially inward movement and the flaps 50a, 50b can be extended radially outward and advanced distally into the wall openings. side 15a, 15b. The flaps 50a, 50b may be configured to move between a first position shown in Figure 5A, in which the flaps 50a, 50b extend through the sidewall openings 15a, 15b and the sharp distal end 33 of the internal drive shaft 32 extends distally beyond a distal end of the external drive shaft 14 and a second position shown in Figure 5B, in which the flaps 50a, 50b are retracted toward the internal drive shaft 32. As the device 20 advances inward of the tissue by a user, the flaps 50a, 50b may contact the outer tissue 100 with the distal facing surfaces 53a, 53b, as shown in Figure 5A. The force transmitted on the flaps 50a, 50b of the outer fabric 100 can cause the sharp distal end 33 of the inner drive shaft 32 to be retracted proximally. This proximal retraction may move the sharp distal end 33 toward a distal end of the intermediate drive shaft 35 and/or the external drive shaft 14. In some embodiments, the distal end 33 may be retracted proximally, so so that it is disposed within the internal lumen of the intermediate drive shaft 35, as shown in Figure 5B. Alternatively, or additionally, the distal end 33 may be retracted so that it is disposed within the inner lumen of the external drive shaft 14. Proximal movement of the inner drive shaft 32 also moves the flaps 50a, 50b proximally in the grooves. 15a, 15b. When the flaps 50a, 50b reach the proximal end of the grooves 15a, 15b, they can retract radially inward, as shown in Figures 5B and 5C. In some embodiments, when the flaps 50a, 50b retract radially inward, a radius of the stop guard 50 may be less than a radius of the outer drive shaft 14 and greater than a radius of the intermediate drive shaft 35, as shown in Figure 5C.

[055] Once the distal tip 33 of the internal drive shaft 32 is retracted proximally into the inner lumen of the intermediate drive shaft 35 and/or the external drive shaft 14, the device 20 can be further advanced distally. - lies into the fabric. In some embodiments, the device 20 may advance far enough into a patient's body such that the side wall openings 15a, 15b, from which the stop guard 50 extends, are positioned within the body of the patient. patient distally from the perforated tissue. Note that there is no resistance to advancing the device in this manner because the stop guard 50 is in a retracted configuration in which the flaps 50a, 50b or other structures of the stop guard 50 are contained within the external drive shaft 14.

[056] If positioned within a patient's body, an end actuator may be coupled to a distal end of the device 20. To attach an end actuator to the distal end of the device 20, the internal drive shaft 32 may first be retracted, as shown in Figure 5C, if it is not already in this position (as mentioned above). Moving the inner drive shaft 32 out of the gap between the outer drive shaft arms 24a, 24b and/or intermediate drive shaft arms 25a, 25b may allow the arms to be deflected radially inward as the mechanism moves. crank-like clamping device 18 of device 20 is inserted into a socket formed in an end actuator. Once the end actuator is correctly positioned relative to the clamping mechanism 18, the internal drive shaft 32 may advance distally to prevent radially inward deflection of the external drive shaft arms 24a, 24b and/or the shaft arms. of intermediate drive shaft 25a, 25b, so that the end actuator cannot be separated from the clamping mechanism 18. Distal advancement of the internal drive shaft 32 may also cause the tabs 50a, 50b of the stop guard 50 advance distally and extend radially outward from the side wall openings 15a, 15b. In this configuration, where the stop guard tabs 50a, 50b are positioned within the body of a patient, the stop guard 50 can prevent inadvertent removal of the device 20, but provide resistance to removal since the guard tabs stops come into contact with the perforated fabric. Conversely, by advancing the device 20 distally through the tissue, however, the configuration of the wings 50a, 50b may allow removal of the device 20 if necessary (e.g., in an emergency). In one embodiment, for example, about 4 pounds of resistive force is provided against withdrawal of the device 20 from the body by the inclined surfaces 52a, 52b of the flaps 50a, 50b. This is in comparison to, for example, about 1 pound of force that is needed for a similar instrument without a 50 stop guard.

[057] In embodiments in which the end actuator is fixed in vivo, the end actuator can be introduced into the body using a loading device that is introduced through a trocar or other appropriately sized opening or port. Once a procedure is completed, the end actuator may be retrieved by the loading device and decoupled from the device 20 by retracting the internal drive shaft 32 proximally to release the shackle-like clamping mechanism 18 to deflect radially inward and release the end actuator. By proximally retracting the internal drive shaft 32 it is also possible to retract the stop protection tabs 50a, 50b radially into the external drive shaft 14, thus allowing the device 20 to be removed from the patient's body without experiencing levels. increased resistance of the jamb protector 50.

[058] Figure 6A illustrates an exemplary embodiment of the method described, in general, above. As shown in Figure 6A, a perforation 101 can be created in an abdominal wall 100 with the use of the device 20. More particularly, the perforation 101 can be created with the use of the sharp distal tip 33 of the internal drive shaft 32 of the instrument 20 passing the internal drive shaft distally through the lumen of the external drive shaft 14 and/or the intermediate drive shaft 35 until it is extended distally beyond the distal end of the external drive shaft and/or the intermediate drive shaft. When the inner drive shaft 32 is advanced distally to pierce tissue, a stop guard 50 may extend radially outward from the outer drive shaft 14 and may contact tissue 100. The force exerted on the stop guard 50 by tissue 100 may cause the internal drive shaft 32 to retract proximally such that a distal end of the internal drive shaft 32 is disposed within an internal lumen of the intermediate drive shaft 35 and/or the external drive shaft 14 (as discussed above in relation to Figures 5A to 5C). This retraction may also cause the stop guard 50 to retract radially inward into the internal lumen of the external drive shaft 14. In this configuration, the device 20 may further advance through the abdominal wall 100 to the position shown in Figure 6A. No resistance is encountered due to the stop guard because it is in a retracted configuration that does not extend from the external drive shaft 14. Additionally, the clamping mechanism 18 is in a configuration where it is ready to accept any of a variety of end actuators for coupling to it. Finally, as shown, the distal end of the device 20 and the elongated drive shaft 12 can pass through the abdominal wall 100 without the use of a trocar or other access port, since the resilient abdominal wall 100 can seal directly against the drive shaft 12 to maintain pneumoperitoneum during a procedure.

[059] In the embodiment illustrated in Figure 6A, the end actuator 105 is inserted into the abdominal cavity using a loading device 200. The loading device 200 can be inserted into the patient's body in a variety of ways, but typically one An incision 103 can be created in a patient's body and a trocar can be positioned within the incision to allow the magazine 200 to pass into the abdominal cavity. The end actuator 105 can be attached to the instrument 20 in several different ways, both outside and inside an individual's body. For example, in some embodiments a distal end of device 20 may be inserted through a trocar so that it exits the patient's body and the end actuator may be secured thereto before the device 20 is pulled back through the trocar. into the abdominal cavity. In other embodiments, however, the end actuator 105 may be configured to be attached to the device 20 within a patient's body or in vivo, e.g., within a body cavity such as the abdominal cavity, and to be removed. and replaced within the patient's body.

[060] The type of end actuator that can be employed is not particularly limited. In general, end actuators may include grippers or may be gripperless end actuators. A variety of different end actuators 105 may be attached and separated from the instrument 20. In some embodiments, the instrument 20 may be operated by the actuator 10 to cause the end actuator 105 to grip the tissue or lock its claws. In other embodiments, operation of the actuator 10 may cause the end actuator to perform other tasks, such as cutting, power supply, etc.

[061] As shown in Figure 6B, the end actuator 105 can be loaded onto the device 20 using a loading device 200. To load the end actuator 105 onto the device 20, the end actuator can be aligned with a longitudinal axis of the elongated drive shaft 12 (i.e. the longitudinal axis z). Additionally, the inner drive shaft 32 may be retracted proximally (if not already in such a configuration) to ensure that the intermediate drive shaft arms 25a, 25b and the outer drive shaft arms 24a, 24b can deflect radially toward inside.

[062] In such a configuration, the device 20 can be advanced distally so that the clamping mechanism 18 (including the intermediate drive shaft arms 25a, 25b and the external drive shaft arms 24a, 24b) is inserted into a coupling socket formed on the end actuator 105. The annular ridges or protuberances formed on the side walls of the coupling socket may slide over the clamping mechanism 18, deflecting the intermediate drive shaft arms 25a, 25b and the shaft arms of external drive 24a, 24b radially inwardly until such ridges or protuberances are seated within the grooves or notches 21, 26a, 26b formed in the arms 24a, 24b, 25a, 25b. The user can experience tactile or audible feedback when the correct position is reached. In this configuration, the end actuator 105 is coupled to the device 20, but can be pulled freely in the same manner as it was fixed due to the deflection of the arms 24a, 24b, 25a, 25b. To lock the end actuator 105 over the device 20, the internal drive shaft 32 may be advanced distally so that the internal drive shaft 32 fills the gap between the arms 24a, 24b, 25a, 25b and prevents any radial deflection to inside. It is noted that this distal advancement of the internal drive shaft 32 may also cause the stop guard 50 to advance distally and extend radially away from the external drive shaft 14, thus providing a stop to prevent inadvertent withdrawal of the device when coupled to an end actuator. A surgeon or other user can then drag the device 20 in the opposite direction to the loading device 200, as shown in Figure 6D, and perform the surgical procedure using the actuator 10 to move the jaws of the end actuator or other tool.

[063] After the function of the end actuator 105 is performed, the instrument 20 can be separated from the end actuator 105 and removed from the surgical site using the reverse of the procedure detailed above. For example, the inner drive shaft 32 may be retracted proximally to allow the end actuator 105 to be pulled away from the device 20 using the loading device 200. Additionally, when the inner drive shaft 32 is retracted proximally to allow By decoupling the end actuator 105, the stop guard 50 can be retracted radially inwardly onto the external drive shaft 14. This can allow the instrument 20 to be removed from the tissue through the perforation 101 without experiencing resistance from the stop guard. 50. The loading device 200 may subsequently be reattached to the end actuator 105 to remove it from the patient's body through the trocar or other port used to introduce the loading device into the patient's body. If additional procedures are required, a new end actuator or a different end actuator may be connected to the charging device 200 and coupled to the device 20 in the manner described above, or the device may be removed from the patient's body if the procedure is completed. .

[064] In addition to the stop protector 50 described above, other features can also be included in surgical devices to additionally protect the tissue and prevent inadvertent removal of the device from the patient's body. For example, in the embodiment shown in Figures 7A to 7D, a wound protector 300 may be included in the instrument 20'. The wound protector 300 can prevent damage to the punctured tissue and can minimize friction and drag forces on the instrument when it is moved proximally and distally in the tissue. In other words, the wound protector 300 may act similarly to a trocar, which maintains an opening formed in the tissue and allows other instruments to pass through the tissue. As shown in the Figures, the wound protector 300 may be a cylindrical sleeve slidably disposed on the external drive shaft 14'. The wound protector 300 may be smooth or with ridges on its outer surface. The ridges 301 on the outer surface of the wound protector 300 may allow the wound protector 300 to better fit with the tissue and prevent movement of the wound protector relative to the punctured tissue.

[065] The wound protector 300 may also function to prevent inadvertent removal of the instrument 20' from the patient's body. For example, the wound protector 300 may be configured so that it engages against a distal end of the external drive shaft 14'. In one embodiment, a user withdrawing the instrument 20' proximally from the configuration shown in Figure 7B would experience substantially no friction until the wound protector 300 reaches the position shown in Figure 7A. At this point, the wound protector 300 may stop sliding over the external drive shaft 14', which may result in the user having to overcome increased resistance for further proximal withdrawal. This is because the wound protector does not move relative to tissue nearly as easily as it moves about the external drive shaft 14', especially if ridges 301 or other gripping features are employed on an external surface of the wound protector 300. .

[066] In some embodiments, the wound protector 300 may include a ridge or annular protuberance 303 formed on an inner side wall thereof near its distal end. This annular ridge or protuberance 303 may be configured to be seated within the circumferential groove 21' of the external drive shaft 14' when the wound protector 300 is in a more distal position with respect to the external drive shaft, as shown in Figures 7C and 7D. The coupling of the protuberance 303 and the groove 21' may serve to define the most distal position of the wound protector 300 which helps prevent inadvertent withdrawal of the device 20.

[067] Positioning the wound protector in the distal position shown in Figures 7C and 7D may also help protect the shackle-like fixation mechanism 18' disposed at the distal end of the device 20'. It should be appreciated that, in certain sizes, the opposing intermediate drive shaft arms 25a', 25b' and the outer drive shaft arms 24a', 24b' may be very small and thin. There is a risk of these arms becoming permanently curved or otherwise deformed if, for example, an end actuator 105 is not correctly aligned during coupling (e.g., if only one of the arms 25a', 25b' enters the socket end actuator coupling while the other arm remains outside the socket, the arms may bend away from each other). It is also possible that tissue or other nearby structures may catch one of the arms 24a', 24b', 25a', 25b' during insertion and/or withdrawal of the instrument. Placing the wound protector 300 in the position shown in Figure 7C and 7D can provide a sheath around the arms that reinforce them and prevent excessive radial outward deflection.

[068] The wound protector 300 is not the only way in which support for the shackle-like fastening mechanism and its arms can be provided. Figure 8, for example, illustrates another embodiment in which the arms are secured using a spring clip 350 disposed around a distal portion of the device. The spring-loaded clamp 350, like a C-shaped snap ring, can engage the arms 24a, 24b of the external drive shaft 14 to provide support and prevent bending or damage to the arms 24a, 24b, 25a, 25b. The spring clamp 350 may be made of material that is less flexible than the material of the arms, but may also be forced to tension the arms 24a, 24b, 25a, 25b while additionally enabling the functionality described above.

[069] In other embodiments, other features may be provided to prevent inadvertent removal of a device during use. For example, in some embodiments, an end actuator may include a flared proximally facing profile (when coupled to the instrument, e.g., as shown in Figure 6D), which may provide increasing resistance to removal similar to shield tabs. inclined stops 50a, 50b. Similar to slanted flaps, a flared shape would prevent inadvertent withdrawal of the instrument, while additionally allowing for removal if necessary (e.g. in an emergency). In other embodiments, a Luer fitting may be included in the elongated drive shaft 12 and/or an end actuator 105 to provide a similar flared shape that may prevent inadvertent withdrawal of the device during use. By way of example, a Luer fitting having an internal diameter corresponding to a diameter of the drive shaft 12 may be slid over the drive shaft with its tapered portion facing proximally to provide a sliding stop that can prevent inadvertent extraction of the shaft. drive 12 from the abdomen or other surgical site.

[070] Any of the components and devices known in the art and/or described herein may be provided as part of a kit that includes an elongated drive shaft and a plurality of end actuators, each configured to be removably coupled and replaceable to a distal end of the elongated drive shaft of the surgical instrument as discussed above. The kit may include one or more percutaneous instruments with a cable and drive shaft, one or more end actuators, and one or more obturators to selectively lock and unlock the end actuator(s) of the instrument(s). s). The end actuators provided in the kit may perform different functions, including but not limited to the functions described herein, and/or may be included together in a single kit to perform a particular function, such as a kit specifically adapted for stretching and stapling of the fabric. Additionally, one or more trocars, ports, chargers, and viewing instruments, such as endoscopes or cameras, may be provided to assist in introducing the instruments and extremity actuators into the surgical site.

[071] The devices described herein may be designed to be discarded after a single use, or may be designed to be used multiple times. In either case, however, the device can be refurbished for reuse after at least one use. Reconditioning may include any combination of the steps of disassembling the device, followed by cleaning or replacing specific parts, and subsequent reassembly. In particular, the device may be disassembled and any number of specific parts or parts of the device may be selectively replaced or removed, in any combination. By cleaning and/or replacing specific parts, the device can be reassembled for subsequent use in the reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will understand that reconditioning a device may use a variety of techniques for disassembly, cleaning/replacement and reassembly. The use of such techniques and the resulting refurbished device are within the scope of the present application.

[072] The devices described here can be processed before use in a surgical procedure. First, a new or used instrument can be obtained and, if necessary, cleaned. The instrument can then be sterilized. In a sterilization technique, the instrument can be placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and its contents can then be placed in a radiation field, such as gamma radiation, X-rays or high-energy electrons, which can penetrate the container. Radiation can kill bacteria on the instrument and in the container. The sterilized instrument can then be stored in a sterile container. The sealed container can keep the instrument sterile until it is opened in the medical facility. Other forms of sterilization known in the art are also possible. This may include beta radiation or other forms of radiation, ethylene oxide, steam, and a liquid bath (e.g., cold immersion). Certain forms of sterilization may be more suitable for use with different portions of the device due to the materials used, the presence of electrical components, etc.

[073] Those skilled in the art will understand other features and advantages of the invention based on the modalities described above. Consequently, the invention should not be limited by what has been particularly shown and described, except as indicated by the attached embodiments. All publications and references cited are expressly incorporated herein in full, by way of reference.

Claims (10)

1. Surgical instrument (20) comprising: an external drive shaft (14) with an internal lumen and at least one opening (15a, 15b) extending through an outer side wall of the external drive shaft (14); an internal drive shaft (32) disposed within the internal lumen of the external drive shaft (14) and configured to translate relative to the external drive shaft (14) along a longitudinal axis thereof, the internal drive shaft (32) including a distal end (33) configured to pierce tissue; and a stop guard (50) coupled to the internal drive shaft (32), the stop guard (50) having at least one retractable flap configured to extend radially outwardly through the at least one opening (15a, 15b) of the external drive shaft (14) as to retract radially inwardly toward the inner drive shaft (32) so that the retractable tab is disposed within a diameter of the outer drive shaft (14); characterized by the fact that, when the at least one retractable tab extends radially outwardly through the at least one opening (15a, 15b) of the external drive shaft (14), the at least one retractable tab is configured to retract radially inwardly toward the internal drive shaft (32) in response to the at least one retractable flap contacting an external object as the instrument (20) advances distally within the tissue, the radially inward retraction of the at least one retractable flap resulting in the distal end (33) of the internal drive shaft (32) retracting proximally towards the distal end of the external drive shaft (14). 2. Instrument (20), according to claim 1, characterized by the fact that it further comprises an intermediate drive shaft (35) with an internal lumen and at least one opening (15a, 15b) extending through an outer side wall of the intermediate drive shaft (35), the intermediate drive shaft (35) being disposed between the outer drive shaft (14) and the inner drive shaft (32) and configured to translate relative to the external drive (14) along a longitudinal axis thereof, the intermediate drive shaft (35) further being configured to translate to a position in which the at least one opening of the intermediate drive shaft (35) is aligned with the over at least a portion of its length with the at least one opening (15a, 15b) of the outer drive shaft (14) and a distal end of the intermediate drive shaft (35) extending distally beyond the distal end of the drive shaft. external drive (14). 3. Instrument (20), according to claim 1, characterized by the fact that, when coming into contact with the external object by at least one retractable flap, the distal end (33) of the internal drive shaft (32 ) retracts proximally towards the distal end of the external drive shaft (14), so that the distal end (33) of the internal drive shaft (32) is disposed within the internal lumen of the external drive shaft (14) . 4. Instrument (20), according to claim 1, characterized by the fact that, when coming into contact with the external object by at least one retractable flap, the distal end (33) of the internal drive shaft (32 ) retracts proximally toward the distal end of the intermediate drive shaft (35), so that the distal end (33) of the internal drive shaft (32) is disposed within the internal lumen of the intermediate drive shaft ( 35). 5. Instrument (20), according to claim 1, characterized by the fact that each of the intermediate and external drive shafts further comprises a first and a second deflectable arms (25a, 25b, 24a, 24b). 6. Instrument (20), according to claim 5, characterized by the fact that it further comprises an end actuator (105) configured to be coupled to at least one of the distal end of the intermediate drive shaft (35) and the distal end of the outer drive shaft (14) by the inner drive shaft (32) extending from the first and second deflectable arms (25a, 25b) of the intermediate drive shaft (35) radially outwardly toward the walls sides of the end actuator (105). 7. Instrument (20), according to claim 6, characterized by the fact that the at least one retractable flap of the stop protector (50) is configured to extend radially outwardly through the at least one opening (15a , 15b) of the external drive shaft (14) when the end actuator (105) is coupled to at least one of the distal end of the intermediate drive shaft (35) and the distal end of the external drive shaft (14). 8. Instrument (20), according to claim 1, characterized by the fact that the stop protector (50) has a completely retracted position, in which the outermost radius of the stop protector (50) is greater than a radius of the intermediate drive shaft (35), but smaller than a radius of the external drive shaft (14). 9. Instrument (20), according to claim 1, characterized by the fact that the at least one retractable flap of the stop protector (50) comprises a first retractable flap and a second retractable flap, wherein the first and the second retractable flaps being configured to extend radially outwardly through the first and second outer sidewall openings of the outer drive shaft (14), respectively, and to retract radially inwardly toward the inner drive shaft (32). ) so that the first and second retractable flaps are arranged within one diameter of the external drive shaft (14). 10. Instrument (20), according to claim 9, characterized by the fact that the first and second retractable flaps are arranged on opposite sides of the internal drive shaft (32) relative to each other.