Medical device for performing minimally invasive surgery

Abstract

A device for performing minimally invasive surgery, the device comprising: a shaft having a distal end and a proximal end; a monopolar knife assembly attached to the distal end of the shaft, the monopolar knife assembly including a knife; a handle attached to the proximal end of the shaft; wherein the shaft includes a flexible portion and an articulated portion, wherein the flexible portion extends distally from the handle, and the articulated portion extends distally from the flexible portion; wherein at least one articulation cable extends from the handle to the articulated portion such that when tension is applied to the at least one articulation cable, the articulated portion deflects; wherein an actuating element extends through the shaft from the handle to the knife such that when the actuating element moves, the knife moves; and wherein the actuating element transmits electrical power from the handle to the knife.

Description

[0001] Applicant

[0002] Lumendi, Inc.

[0003] Inventor

[0004] Jonathan O'Keefe

[0005] Jeffrey Cerier

[0006] Amos Cruz

[0007] David Rezac

[0008] Niklas Helmick

[0009] Peter Aliski

[0010] Andrew Caunter.

[0011] Citation of Pending Prior Patent Application

[0012] This patent application:

[0013] (1) is a partial continuation application of the pending U.S. patent application Ser. No. 15 / 298,605, filed Oct. 20, 2016, by Lumendi, Inc. and Jonathan O'Keefe et al. for MEDICAL INSTRUMENTS FOR PERFORMING MINIMALLY - INVASIVE PROCEDURES (Attorney Docket No. LUMENDI - 051114), which claims the benefit of:

[0014] (i) the prior U.S. Provisional Patent Application Ser. No. 62 / 244,026, filed Oct. 20, 2015, by Lumendi, Inc. and Jonathan O'Keefe et al. for MEDICAL INSTRUMENTS FOR PERFORMING MINIMALLY - INVASIVE PROCEDURES (Attorney Docket No. LUMENDI - 5PROV); and

[0015] (ii) U.S. Provisional Patent Application Serial No. 62 / 400,759, filed on September 28, 2016, by Lumendi, Inc. and Jonathan O'Keefe et al. for MEDICAL INSTRUMENTS FOR PERFORMING MINIMALLY-INVASIVE PROCEDURES (Attorney Docket No. LUMENDI-1114PROV); and

[0016] (2) Claims the benefit of: U.S. Provisional Patent Application Serial No. 62 / 855,308, filed on May 31, 2019, by Lumendi, Inc. and Jonathan O'Keefe et al. for MEDICAL INSTRUMENTS FOR PERFORMING MINIMALLY-INVASIVE PROCEDURES (Attorney Docket No. LUMENDI-18 PROV), which is pending.

[0017] These four (4) above-mentioned patent applications are hereby incorporated by reference into this application. TECHNICAL FIELD

[0018] The present invention generally relates to medical devices, and more particularly to medical devices for performing minimally invasive procedures. BACKGROUND OF THE INVENTION

[0019] Minimally invasive medical procedures have become common. In a typical minimally invasive procedure, access to an internal site is achieved through one or more small incisions (e.g., natural body orifices, small incisions in the skin, etc.). An endoscope (e.g., colonoscope, arthroscope, endoscope, etc.) is inserted through the incision to facilitate visual observation of the internal site, and then one or more medical devices are inserted through the same incision (e.g., via an internal channel in the endoscope) or through another incision so that the medical devices can be used to perform a procedure at the internal site under the visual observation provided by the endoscope.

[0020] In many cases, it may be difficult to reach internal sites due to anatomical constraints, device limitations, etc. By way of example and not limitation, in many situations, it may be desirable for a medical device to advance through the internal channel of an endoscope to an internal site or for the medical device to advance beside the endoscope to an internal site and then bend (e.g., along a short radius) to facilitate entry into the field of view of the endoscope such that a desired procedure can be performed under visual observation provided by the endoscope. And in many cases, the path that the medical device needs to advance along (e.g., within the colon lumen) may be tortuous. In such a situation, it is necessary for the medical device to be highly flexible, capable of articulating with a range of different motions, and configured for precise control while being operated only from the handle end of the medical device (i.e., the proximal end) (e.g., along a tortuous path). In practice, this is extremely difficult to achieve.

[0021] The present invention is intended to provide a novel medical device capable of achieving such functions. Summary of the Invention

[0022] The present invention includes a novel medical device for performing minimally invasive surgery. The novel medical device is highly flexible, capable of articulating with a range of different motions, and configured for precise control while being operated only from the handle end of the medical device (e.g., along a tortuous path).

[0023] The novel medical device generally includes a handle and a shaft extending distally from the handle. The shaft generally includes an elongate flexible proximal portion and a distal articulating portion mounted to the distal end of the flexible proximal portion. An end effector is mounted to the distal end of the distal articulating portion. The end effector can take many different forms (e.g., a grasper, an injection needle, scissors, a thermal ablator, a monopolar probe, a hemostatic clip, a bipolar forceps, a suction tube, a single-shot or multi-shot closure device such as staples and a stapler, a dissecting forceps, a retrieval basket, a monopolar scissors, a monopolar knife, a monopolar knife with irrigation capabilities, etc.). For the sake of clarity of illustration, the end effector is shown as a grasper in the figures. The handle can take any of many different forms (e.g., a pistol grip, a shaft grip, etc.). For the sake of clarity of illustration, the handle is shown as a pistol grip in the figures.

[0024] According to the present invention, the flexible proximal portion of the shaft is configured to be a highly flexible element that can extend along a serpentine path for a relatively long length (e.g., 95 cm - 140 cm). The distal articulating portion of the shaft is configured to be capable of universal articulation relative to the distal end of the flexible proximal portion of the shaft, and the end effector is configured to selectively rotate relative to the distal end of the distal articulating portion and can be selectively actuated, and all functions can be implemented by a user's single hand via the handle. In a preferred form of the present invention, substantially the entire shaft of the medical device is flexible. The portion of the shaft proximal to the transition point (i.e., the flexible proximal portion) is passively flexible (e.g., capable of following a serpentine path), and the portion of the shaft distal to the transition point (i.e., the distal articulating portion) is actively flexible (e.g., capable of being universally articulated to a desired configuration).

[0025] As will be described in more detail below, the novel medical device can perform at least the following movements:

[0026] Movement 1 - Longitudinal movement of the end effector achieved by longitudinal movement of the handle (sometimes referred to hereinafter as the "longitudinal movement function");

[0027] Movement 2 - Rotational movement of the end effector achieved by rotational movement of the handle (sometimes referred to hereinafter as the "twisting movement function");

[0028] Movement 3 - Articulating movement of the end effector relative to the handle achieved by articulating the distal articulating portion of the shaft relative to the distal end of the flexible proximal portion of the shaft (sometimes referred to hereinafter as the "universal articulation function");

[0029] Movement 4 - Rotational movement of the end effector relative to the distal end of the distal articulating portion of the shaft achieved by rotating the end effector relative to the shaft (sometimes referred to hereinafter as the "rotation function"); and

[0030] Movement 5 - Actuation of the end effector, e.g., selectively moving the elements of the end effector relative to each other to facilitate performing a medical procedure, e.g., opening and closing the jaws of a gripper - type end effector (sometimes referred to hereinafter as the "jaw opening / closing function").

[0031] In a preferred form of the present invention, a device for performing minimally invasive surgery is provided, the device comprising:

[0032] A tool, which comprises:

[0033] A shaft having a distal end and a proximal end;

[0034] A handle attached to the proximal end of the shaft; and

[0035] An end effector attached to the distal end of the shaft;

[0036] The shaft includes a flexible portion extending distally from the proximal end of the shaft and an articulated portion extending proximally from the distal end of the shaft, and wherein the articulated portion includes a flexible ridge;

[0037] A plurality of articulated cables extend from the handle through the shaft to the flexible ridge, each of the plurality of articulated cables having an articulated cable housing disposed around the articulated cable such that when tension is applied to at least one of the plurality of articulated cables, the flexible ridge bends and the articulated cable housing provides a reaction force to the flexible ridge;

[0038] A rotatable element extends from the handle through the shaft to the end effector such that when the rotatable element rotates, the end effector rotates; and

[0039] An actuating element extends from the handle through the shaft to the end effector such that when the actuating element moves, the end effector is actuated.

[0040] In another preferred form of the present invention, a method for performing minimally invasive surgery is provided, the method comprising:

[0041] Obtaining a device for performing minimally invasive surgery, the device comprising:

[0042] A tool, which includes:

[0043] A shaft having a distal end and a proximal end;

[0044] A handle attached to the proximal end of the shaft; and

[0045] An end effector attached to the distal end of the shaft;

[0046] Wherein the shaft includes a flexible portion extending distally from the proximal end of the shaft and an articulated portion extending proximally from the distal end of the shaft, and wherein the articulated portion includes a flexible ridge;

[0047] A plurality of articulated cables extend from the handle through the shaft to the flexible ridge, each of the plurality of articulated cables having an articulated cable housing disposed around the articulated cable such that when tension is applied to at least one of the plurality of articulated cables, the flexible ridge bends and the articulated cable housing provides a reaction force to the flexible ridge;

[0048] A rotatable element extends from the handle through the shaft to the end effector such that when the rotatable element rotates, the end effector rotates; and

[0049] An actuating element extends from the handle through the shaft to the end effector such that when the actuating element moves, the end effector is actuated; and

[0050] Using the device to perform minimally invasive surgery.

[0051] In another preferred form of the present invention, there is provided an apparatus for performing minimally invasive surgery, the apparatus comprising:

[0052] Tools, including:

[0053] a shaft having a distal end and a proximal end;

[0054] a handle attached to the proximal end of the shaft; and

[0055] an end effector, which is attached to the distal end of the shaft;

[0056] wherein the shaft includes a flexible portion extending distally from a proximal end of the shaft and an articulated portion extending proximally from a distal end of the shaft, and wherein the articulated portion includes a flexible spine;

[0057] wherein a plurality of articulation cables extend from the handle through the shaft to the flexible spine such that when tension is applied to at least one of the plurality of articulation cables, the flexible spine flexes;

[0058] wherein the rotatable element extends from the handle to the end effector through a shaft such that when the rotatable element is rotated, the end effector is rotated, wherein the rotatable element comprises a hollow tubular structure extending distally from the handle, the hollow tubular structure being formed from a plurality of filaments that are wound and swaged together, and further wherein the rotatable element further comprises a laser cut hypotube secured to the hollow tubular structure such that when the hollow tubular structure is rotated, the laser cut hypotube is also rotated; and

[0059] Wherein the actuating element extends from the handle to the end effector through a shaft, so that when the actuating element moves, the end effector is actuated.

[0060] In another preferred form of the invention, there is provided a method for performing minimally invasive surgery, the method comprising:

[0061] Obtain equipment for performing minimally invasive surgery, including:

[0062] Tools, including:

[0063] a shaft having a distal end and a proximal end;

[0064] a handle attached to the proximal end of the shaft; and

[0065] an end effector, which is attached to the distal end of the shaft;

[0066] wherein the shaft includes a flexible portion extending distally from a proximal end of the shaft and an articulated portion extending proximally from a distal end of the shaft, and wherein the articulated portion includes a flexible spine;

[0067] wherein a plurality of articulation cables extend from the handle through the shaft to the flexible spine such that when tension is applied to at least one of the plurality of articulation cables, the flexible spine flexes;

[0068] wherein the rotatable element extends from the handle to the end effector through a shaft such that when the rotatable element is rotated, the end effector is rotated, wherein the rotatable element comprises a hollow tubular structure extending distally from the handle, the hollow tubular structure being formed from a plurality of filaments that are wound and swaged together, and further wherein the rotatable element further comprises a laser cut hypotube secured to the hollow tubular structure such that when the hollow tubular structure is rotated, the laser cut hypotube is also rotated; and

[0069] wherein the actuating element extends from the handle to the end effector through a shaft such that when the actuating element moves, the end effector is actuated; and

[0070] Use this device to perform minimally invasive surgery.

[0071] In another preferred form of the present invention, there is provided an apparatus for performing minimally invasive surgery, the apparatus comprising:

[0072] Tools, including:

[0073] a shaft having a distal end and a proximal end;

[0074] a handle attached to the proximal end of the shaft; and

[0075] an end effector, which is attached to the distal end of the shaft;

[0076] wherein the shaft includes a flexible portion extending distally from a proximal end of the shaft and an articulated portion extending proximally from a distal end of the shaft, and wherein the articulated portion includes a flexible spine;

[0077] wherein a plurality of articulation cables extend from the handle through the shaft to the flexible spine such that when tension is applied to at least one of the plurality of articulation cables, the flexible spine flexes;

[0078] wherein the rotatable element extends from the handle to the end effector through a shaft such that when the rotatable element is rotated, the end effector rotates;

[0079] wherein the actuating element extends from the handle to the end effector through a shaft such that when the actuating element moves, the end effector is actuated; and

[0080] The flexible portion of the shaft includes an outer coil secured to the flexible spine, a rigid tube configured to rotate relative to the handle, and an outer covering secured to the rigid tube and the flexible spine such that rotation of the rigid tube causes rotation of the outer covering, which causes rotation of the flexible spine.

[0081] In another preferred form of the invention, there is provided a method for performing minimally invasive surgery, the method comprising:

[0082] Obtain equipment for performing minimally invasive surgery, including:

[0083] A tool, comprising:

[0084] A shaft having a distal end and a proximal end;

[0085] A handle attached to the proximal end of the shaft; and

[0086] An end effector attached to the distal end of the shaft;

[0087] wherein the shaft includes a flexible portion extending distally from the proximal end of the shaft and a hinged portion extending proximally from the distal end of the shaft, and wherein the hinged portion includes a flexible ridge;

[0088] wherein a plurality of hinge cables extend through the shaft from the handle to the flexible ridge such that when tension is applied to at least one of the plurality of hinge cables, the flexible ridge bends;

[0089] wherein a rotatable element extends through the shaft from the handle to the end effector such that when the rotatable element rotates, the end effector rotates;

[0090] wherein an actuating element extends through the shaft from the handle to the end effector such that when the actuating element moves, the end effector is actuated; and

[0091] wherein the flexible portion of the shaft includes an outer coil fastened to the flexible ridge, a rigid tube configured to rotate relative to the handle, and an outer covering fastened to the rigid tube and the flexible ridge such that rotation of the rigid tube causes rotation of the outer covering, which causes rotation of the flexible ridge; and

[0092] Using the device to perform minimally invasive surgery.

[0093] In another preferred form of the present invention, there is provided a device for performing minimally invasive surgery, the device comprising:

[0094] A tool, comprising:

[0095] A shaft having a distal end and a proximal end;

[0096] A handle attached to the proximal end of the shaft; and

[0097] An end effector attached to the distal end of the shaft;

[0098] wherein the shaft includes a flexible portion extending distally from the proximal end of the shaft and a hinged portion extending proximally from the distal end of the shaft, and wherein the hinged portion includes a flexible ridge;

[0099] wherein a plurality of hinge cables extend through the shaft from the handle to the flexible ridge such that when tension is applied to at least one of the plurality of hinge cables, the flexible ridge bends;

[0100] Wherein the rotatable element extends from the handle to the end effector through a shaft such that when the rotatable element rotates, the end effector rotates;

[0101] Wherein the actuating element extends from the handle to the end effector through a shaft such that when the actuating element moves, the end effector is actuated; and

[0102] Wherein the proximal end of the shaft further includes a rigid portion, and wherein the device further includes a tool support mounted to the patient support, the tool support including an opening for receiving the rigid portion.

[0103] In another preferred form of the present invention, there is provided a method for performing minimally invasive surgery, the method comprising:

[0104] Obtaining a device for performing minimally invasive surgery, the device comprising:

[0105] A tool, which includes:

[0106] A shaft having a distal end and a proximal end;

[0107] A handle attached to the proximal end of the shaft; and

[0108] An end effector attached to the distal end of the shaft;

[0109] Wherein the shaft includes a flexible portion extending distally from the proximal end of the shaft and a hinged portion extending proximally from the distal end of the shaft, and wherein the hinged portion includes a flexible ridge;

[0110] Wherein a plurality of hinge cables extend from the handle through the shaft to the flexible ridge such that when tension is applied to at least one of the plurality of hinge cables, the flexible ridge bends;

[0111] Wherein the rotatable element extends from the handle to the end effector through a shaft such that when the rotatable element rotates, the end effector rotates;

[0112] Wherein the actuating element extends from the handle to the end effector through a shaft such that when the actuating element moves, the end effector is actuated; and

[0113] Wherein the proximal end of the shaft further includes a rigid portion, and wherein the device further includes a tool support mounted to the patient support, the tool support including an opening for receiving the rigid portion; and

[0114] Using the device to perform minimally invasive surgery.

[0115] In another preferred form of the present invention, there is provided a device for performing minimally invasive surgery, the device comprising:

[0116] A tool, which includes:

[0117] A shaft having a distal end and a proximal end;

[0118] A handle, which is attached to the proximal end of the shaft; and

[0119] An end effector, which is attached to the distal end of the shaft;

[0120] wherein the shaft includes a flexible portion extending distally from the proximal end of the shaft and an articulated portion extending proximally from the distal end of the shaft, and wherein the articulated portion includes a flexible ridge;

[0121] wherein a plurality of hinge cables extend through the shaft from the handle to the flexible ridge such that when tension is applied to at least one of the plurality of hinge cables, the flexible ridge bends;

[0122] wherein a rotatable element extends through the shaft from the handle to the end effector such that when the rotatable element rotates, the end effector rotates; and

[0123] wherein an actuating element extends through the shaft from the handle to the end effector such that when the actuating element moves, the end effector is actuated;

[0124] The shaft is configured to cause rotation of the rotatable element to occur when the articulated portion has been articulated, without spring energy accumulating within the shaft.

[0125] In another preferred form of the present invention, a method for performing minimally invasive surgery is provided, the method comprising:

[0126] Obtaining a device for performing minimally invasive surgery, the device comprising:

[0127] A tool, which comprises:

[0128] A shaft, which has a distal end and a proximal end;

[0129] A handle, which is attached to the proximal end of the shaft; and

[0130] An end effector, which is attached to the distal end of the shaft;

[0131] wherein the shaft includes a flexible portion extending distally from the proximal end of the shaft and an articulated portion extending proximally from the distal end of the shaft, and wherein the articulated portion includes a flexible ridge;

[0132] wherein a plurality of hinge cables extend through the shaft from the handle to the flexible ridge such that when tension is applied to at least one of the plurality of hinge cables, the flexible ridge bends;

[0133] wherein a rotatable element extends through the shaft from the handle to the end effector such that when the rotatable element rotates, the end effector rotates; and

[0134] wherein an actuating element extends through the shaft from the handle to the end effector such that when the actuating element moves, the end effector is actuated;

[0135] The shaft is configured to cause rotation of the rotatable element when the articulated portion has been articulated, without spring energy accumulating within the shaft; and

[0136] using the device to perform minimally invasive surgery.

[0137] In another preferred form of the present invention, there is provided a device for performing minimally invasive surgery, the device comprising:

[0138] a tool, which comprises:

[0139] a shaft having a distal end and a proximal end;

[0140] a handle attached to the proximal end of the shaft; and

[0141] an end effector attached to the distal end of the shaft;

[0142] wherein the shaft includes a flexible portion extending distally from the proximal end of the shaft and an articulated portion extending proximally from the distal end of the shaft, and wherein the articulated portion includes a flexible ridge;

[0143] wherein a plurality of articulating cables extend through the shaft from the handle to the flexible ridge such that when tension is applied to at least one of the plurality of articulating cables, the flexible ridge bends;

[0144] wherein a rotatable element extends through the shaft from the handle to the end effector such that when the rotatable element rotates, the end effector rotates; and

[0145] wherein an actuating element extends through the shaft from the handle to the end effector such that when the actuating element moves, the end effector is actuated.

[0146] In another preferred form of the present invention, there is provided a method for performing minimally invasive surgery, the method comprising:

[0147] obtaining a device for performing minimally invasive surgery, the device comprising:

[0148] a tool, which comprises:

[0149] a shaft having a distal end and a proximal end;

[0150] a handle attached to the proximal end of the shaft; and

[0151] an end effector attached to the distal end of the shaft;

[0152] wherein the shaft includes a flexible portion extending distally from the proximal end of the shaft and an articulated portion extending proximally from the distal end of the shaft, and wherein the articulated portion includes a flexible ridge;

[0153] A plurality of articulated cables extend from the handle to the flexible spine through a shaft such that when tension is applied to at least one of the plurality of articulated cables, the flexible spine bends;

[0154] A rotatable element extends from the handle to the end effector through a shaft such that when the rotatable element rotates, the end effector rotates; and

[0155] An actuating element extends from the handle to the end effector through a shaft such that when the actuating element moves, the end effector is actuated; and

[0156] Using the device to perform minimally invasive surgery.

[0157] In another form of the present invention, a novel monopolar knife is provided.

[0158] And in another form of the present invention, a novel method for using a monopolar knife to cut tissue is provided.

[0159] In yet another form of the present invention, a novel monopolar knife with irrigation ability is provided.

[0160] And in another form of the present invention, a novel method for using a monopolar knife with irrigation ability to cut tissue is provided.

[0161] In a preferred form of the present invention, a device for performing minimally invasive surgery is provided, the device comprising:

[0162] A shaft having a distal end and a proximal end;

[0163] A monopolar knife assembly attached to the distal end of the shaft, the monopolar knife assembly including a knife;

[0164] A handle attached to the proximal end of the shaft;

[0165] Wherein the shaft includes a flexible portion and an articulated portion, wherein the flexible portion extends distally from the handle and the articulated portion extends distally from the flexible portion;

[0166] At least one articulated cable extends from the handle to the articulated portion such that when tension is applied to the at least one articulated cable, the articulated portion deflects;

[0167] An actuating element extends from the handle to the knife through the shaft such that when the actuating element moves, the knife moves; and

[0168] Wherein the actuating element transmits electrical power from the handle to the knife.

[0169] In another preferred form of the present invention, a method for generating a blister in tissue is provided, the method comprising:

[0170] Providing a device, the device comprising:

[0171] A shaft having a distal end and a proximal end;

[0172] A monopolar knife assembly attached to the distal end of the shaft, the monopolar knife assembly including a knife;

[0173] A handle attached to the proximal end of the shaft;

[0174] Wherein the shaft and the handle are configured such that fluid can be transferred from the handle to the distal end of the shaft and into the tissue;

[0175] Wherein an actuating element extends through the shaft from the handle to the knife such that when the actuating element is moved, the knife moves; and

[0176] Wherein the actuating element transmits electrical power from the handle to the knife;

[0177] Inserting the knife through the tissue to be excised; and

[0178] Injecting fluid into the tissue to cause the tissue to be excised to rise away from the underlying tissue.

[0179] In another preferred form of the present invention, there is provided a method for performing minimally invasive surgery, the method comprising:

[0180] Providing a device for performing minimally invasive surgery, the device comprising:

[0181] A shaft having a distal end and a proximal end;

[0182] A monopolar knife assembly attached to the distal end of the shaft, the monopolar knife assembly including a knife;

[0183] A handle attached to the proximal end of the shaft;

[0184] Wherein the shaft includes a flexible portion and a hinged portion, wherein the flexible portion extends distally from the handle and the hinged portion extends distally from the flexible portion;

[0185] Wherein at least one hinge cable extends from the handle to the hinged portion such that when tension is applied to the at least one hinge cable, the hinged portion deflects;

[0186] Wherein an actuating element extends through the shaft from the handle to the knife such that when the actuating element is moved, the knife moves; and

[0187] Wherein the actuating element transmits electrical power from the handle to the knife; and

[0188] Using the device to perform minimally invasive surgery. Description of the Drawings

[0189] These and other objects and features of the present invention will be more fully disclosed or will become apparent from the following detailed description of the preferred embodiments of the present invention, which will be considered in conjunction with the appended Figure 1 drawings, in which like reference numerals refer to like parts, and further, in the drawings:

[0190] Figure 1 is a schematic view showing a novel medical device formed in accordance with the present invention;

[0191] Figure 1A is a schematic view showing Figure 1 the handle and the proximal end of the shaft of the novel medical device shown in

[0192] Figure 1B is a schematic view showing Figure 1 the distal end of the shaft and the end effector of the novel medical device shown in

[0193] Figures 2-23 is a schematic view showing Figure 1 more details of the shaft and the end effector of the novel medical device shown in

[0194] Figures 24-46B is a schematic view showing Figure 1 more details of the handle and the proximal end of the shaft of the novel medical device shown in

[0195] Figures 47-55 is a schematic view showing a novel tool support that can be used in conjunction with the novel medical device shown in Figure 1 ;

[0196] Figures 56-58F is a schematic view showing another novel medical device formed in accordance with the present invention;

[0197] Figures 59-62 is a schematic view showing another form of end effector for the novel medical device of the present invention;

[0198] Figures 63-66 is a schematic view showing another novel medical device formed in accordance with the present invention;

[0199] Figures 67-72 is a schematic view showing another novel medical device formed in accordance with the present invention;

[0200] Figure 73 and Figure 74 is a schematic view showing another novel medical device formed in accordance with the present invention;

[0201] Figure 75 and Figure 76Is a schematic diagram showing another novel medical device formed according to the present invention;

[0202] Figures 77-80 Is a schematic diagram showing another novel medical device formed according to the present invention;

[0203] Figures 81-98 Is a schematic diagram showing another novel medical device formed according to the present invention;

[0204] Figures 98A-98F Is for generating blisters and cutting tissue Figures 81-98 Schematic diagram of a novel medical device;

[0205] Figure 99 Is a schematic diagram showing another handle configuration that can be used to deliver monopolar electrical power to the end effector; and

[0206] Figures 100-108 Is a schematic diagram showing another novel medical device formed according to the present invention. Detailed Description

[0207] 1 Overview of the New Medical Device

[0208] The present invention includes a novel medical device for performing minimally invasive surgery. The novel medical device is highly flexible, capable of articulating in a range of different motions, and is configured for precise control while operating only from the handle end of the medical device (e.g., along a serpentine path).

[0209] First observe Figure 1 、 Figure 1A 、 Figure 1B And Figure 2 , showing a novel medical device 5 formed according to the present invention. The novel medical device 5 generally includes a handle 10 and a shaft 15 extending distally from the handle 10. The shaft 15 generally includes an elongate flexible proximal portion 20 and a distal articulating portion 25 mounted to the distal end of the flexible proximal portion 20. An end effector 30 is mounted to the distal end of the distal articulating portion 25. The end effector 30 can take many different forms (e.g., a grasper, an injection needle, scissors, a thermal ablator, a monopolar probe, a hemostatic clip, a bipolar forceps, a suction tube, a single-shot or multi-shot closure device such as a staple and a stapler, a dissecting forceps, a retrieval basket, a monopolar scissors, a monopolar knife, a monopolar knife with irrigation capabilities, etc.). For clarity of illustration, the end effector 30 is shown as a grasper in the figures. The handle 10 can take any of many different forms (e.g., a pistol grip, a shaft grip, etc.). For clarity of illustration, the handle 10 is shown as a pistol grip in the figures.

[0210] According to the present invention, the flexible proximal portion 20 of the shaft 15 is configured to be a highly flexible element that can extend along a serpentine path for a relatively long length (e.g., 95 cm - 140 cm), the distal articulated portion 25 of the shaft 15 is configured to be gimbal articulated relative to the distal end of the flexible proximal portion 20 of the shaft 15, and the end effector 30 is configured to be selectively rotated and selectively actuated relative to the distal end of the distal articulated portion 25, and all functions can be implemented by a single hand of a user via the handle 10. In a preferred form of the present invention, substantially the entire shaft 15 of the medical device 5 is flexible, the portion of the shaft 15 proximal to the transition point 32 (i.e., the flexible proximal portion 20) is passively flexible (e.g., can follow a serpentine path), and the portion of the shaft 15 distal to the transition point 32 (i.e., the distal articulated portion 25) is actively flexible (e.g., can be gimbal articulated into a desired configuration).

[0211] As will be described in more detail below, the novel medical device 5 is capable of performing at least the following motions:

[0212] Motion 1 - Longitudinal movement of the end effector 30 achieved by longitudinal movement of the handle 10 (sometimes referred to herein as the "longitudinal motion function");

[0213] Motion 2 - Rotational movement of the end effector 30 achieved by rotational movement of the handle 10 (sometimes referred to herein as the "twisting motion function");

[0214] Motion 3 - Articulated movement of the end effector 30 relative to the handle 10 achieved by articulating the distal articulated portion 25 of the shaft 15 relative to the distal end of the flexible proximal portion 20 of the shaft 15 (sometimes referred to herein as the "gimbal articulation function");

[0215] Motion 4 - Rotational movement of the end effector 30 relative to the distal end of the distal articulated portion 25 of the shaft 15 achieved by rotating the end effector 30 relative to the shaft 15 (sometimes referred to herein as the "rotation function"); and

[0216] Motion 5 - Actuation of the end effector 30, e.g., selectively moving elements of the end effector 30 relative to each other to facilitate performing a medical procedure, e.g., opening and closing the jaws of a gripper-type end effector (sometimes referred to herein as the "jaw opening / closing function").

[0217] 2 Structure of Shaft 15

[0218] 2.1 Flexible Proximal Portion 20

[0219] Now observe Figure 1 、 Figure 1A 、 Figure 1B andFigures 2-4 The flexible proximal portion 20 of the shaft 15 generally comprises an elongated flexible outer coil 35 ( Figure 2 and Figure 3 ), the outer coil 35 has a distal end 40, a proximal end 45, and an inner cavity 50 extending therebetween. The distal articulated portion 25 of the shaft 15 is mounted to the distal end 40 of the outer coil 35 via an intervening element (see below). The proximal end 45 of the outer coil 35 is secured to a shaft adapter 55, which in turn is secured to the handle 10 (see below).

[0220] As will be discussed in more detail below, means for selectively articulating the distal articulated portion 25 relative to the distal end of the flexible proximal portion 20 (i.e., relative to the distal end 40 of the outer coil 35), means for selectively rotating the end effector 30 relative to the distal articulated portion 25, and means for selectively actuating the end effector 30 extend through the inner cavity 50 of the outer coil 35.

[0221] In one preferred form of the invention, as will be discussed in more detail below, the rigid tube 60 ( Figure 1A and Figure 4 ) is disposed at the proximal end of the flexible proximal portion 20 (i.e., disposed around the proximal end 45 of the outer coil 35 and secured to the shaft adapter 55), thereby providing an area of ​​increased rigidity for mounting the novel medical device 5 to a tool support (e.g., a table-mounted tool support). If desired, the rigid tube 60 may include a chamfer 65 ( Figure 4 ), the chamfer 65 provides a smooth transition between the outer surface of the rigid tube 60 and the outer surface of the portion of the flexible proximal portion 20 located distal to the rigid tube 60.

[0222] 2.2 Overview of Distal Articulating Portion 25

[0223] As discussed above, the distal articulating portion 25 is configured to selectively articulate relative to the distal end of the flexible proximal portion 20. To this end, and now viewing Figure 2 and Figure 5 , the distal articulation portion 25 generally includes a distal articulation coupling assembly 70, a proximal articulation coupling assembly 75, and a flexure spine 80 extending between the distal articulation coupling assembly 70 and the proximal articulation coupling assembly 75. As will be discussed in more detail below, the proximal articulation coupling assembly 75 is configured to be mounted to the distal end of the flexible proximal portion 20 of the shaft 15 and provide a reaction force surface to allow selective articulation of the distal articulation coupling assembly 70 and the flexure spine 80.

[0224] 2.2.1 Proximal Articulating Linkage Assembly 75

[0225] Watch Now Figure 2 and Figure 6, the proximal articulation coupling assembly 75 is disposed at the distal end 40 of the outer coil 35 of the flexible proximal portion 20. The distal end of the proximal articulation coupling assembly 75 provides a reaction force surface to allow selective flexion of the distal articulation coupling assembly 70 and the flexion ridge 80 relative to the distal end of the flexible proximal portion 20 of the shaft 15 (i.e., to achieve universal articulation of the distal articulation portion 25).

[0226] More particularly, as will be discussed in greater detail below, the proximal articulated coupling assembly 75 ( Figure 6 ) includes a body 85 having a pair of distally extending fingers 90 configured to engage the flexion spine 80 ( Figure 5 Around the center hole 100 ( Figure 18 ) are provided with a plurality of holes 95 ( Figure 6 ) is formed in body 85 and is sized to receive a plurality of articulation cables (see below). As will be discussed below, if desired, bore 95 may include a counterbore (not shown) disposed at a proximal end of bore 95 to receive an articulation cable housing. As will be discussed below, central bore 100 ( Figure 18 ) may include a counterbore 102 ( Figure 6 and Figure 18 ), a counterbore 102 is disposed at the distal end of the center hole 100 to facilitate mounting the distal articulated coupling assembly 70 to the body 85.

[0227] As will be discussed below, the body 85 of the proximal articulation coupling assembly 75 is pressed against a plurality of articulation cable housings 235 (see below), which in turn are pressed against the handle 10 so that the proximal articulation coupling assembly 75 provides a reaction force surface to selectively flex the distal articulation portion 25 of the shaft 15. Note that the outer coil 35 is secured to the body 85 of the proximal articulation coupling assembly 75 but provides substantially no reaction force to the body 85, which is provided by the articulation cable housings.

[0228] 2.2.2 Distal Articulating Linkage Assembly 70

[0229] Watch Now Figure 2 , Figure 5 as well as Figure 7 The distal articulated coupling assembly 70 generally includes a body 105 ( Figure 7 ), the body 105 has a central opening 110 through the body 105 and a short laser cut hypotube 115 extending proximally from the body 105. The short laser cut hypotube 115 includes a distal end 120, a proximal end 125, and an inner cavity 130 extending therebetween. As will be discussed below, the short laser cut hypotube 115 is configured to be highly flexible but with sufficient strut strength to facilitate compression of the proximal end 125 of the short laser cut hypotube 115 against the body 85 (Figure 6 ) When an eccentric proximal force is applied to the body 105, selective articulation of the body 105 relative to the proximal articulation assembly 75 is permitted. The proximal end 125 of the short laser-cut hypotube 115 is mounted (e.g., by welding) to the body 85 of the proximal articulation assembly 75. The distal end 120 of the short laser-cut hypotube 115 is mounted (e.g., by welding) to the body 105. When the distal articulation assembly 70 is in its relaxed (i.e., unbiased) condition, the lumen 130 of the short laser-cut hypotube 115 is aligned with the central opening 110 of the body 105. Due to this configuration, rotation of the body 85 of the proximal articulation assembly 75 causes rotation of the laser-cut hypotube 115, thereby causing rotation of the body 105 of the distal articulation assembly 70. As will be discussed in more detail below, the body 105 also includes a pair of distal seats 135 (only one of which is shown in Figure 7 ), and the distal seats 135 are for mounting one or more hinge cables to the body 105. As will be discussed in more detail below, the body 105 also includes two proximally extending fingers 137, and the fingers 137 are for mating with the flexion ridge 80 ( Figure 5 ).

[0230] 2.2.3 Flexure Ridge 80

[0231] Now observe Figure 5 , the flexion ridge 80 generally includes a flexible body 140 having a distal end 141 and a proximal end 142. A central hole 150 and a plurality of axially aligned openings 145 extend between the distal end 141 and the proximal end 142. As will be discussed below, the openings 145 are sized to each receive a hinge cable therein. The central hole 150 is sized to receive the short laser-cut hypotube 115 of the distal articulation assembly 70 ( Figure 7 ). The proximal end 142 of the flexion ridge 80 includes a proximal seat 155 for receiving the aforementioned distally extending finger 90 of the proximal articulation assembly 75 ( Figure 6 ), and the distal end 141 of the flexion ridge 80 includes a distal seat 160 for receiving the aforementioned proximally extending finger 137 of the distal articulation assembly 70 ( Figure 7 ). It will be appreciated that when the flexion ridge 80 is mounted in this manner, the flexion ridge 80 is fixed against rotation relative to the distal articulation assembly 70 or the proximal articulation assembly 75.

[0232] 2.2.4 Rotatable Housing Assembly 165

[0233] Next observe Figure 5 and Figures 8-12 , as will be discussed below, the distal end of the distal articulation portion 25 includes a rotatable housing assembly 165 (Figure 9 ) The rotatable housing assembly 165 is used to rotatably mount the end effector 30 to the distal articulation assembly 70.

[0234] More particularly, the rotatable housing assembly 165 generally includes a collar 170, an elongate laser cut hypotube 180 having a distal end 185, a proximal end 190, and a lumen 195 extending therebetween. The rotatable housing assembly 165 also includes a rotary connector 200 ( Figure 9 and Figure 10 ), the rotary connector 200 having an opening 205 formed therein, the rotary connector 200 being fixedly mounted to the distal end 185 of the elongate laser cut hypotube 180 such that when the rotatable housing assembly 165 is in its relaxed (i.e., unbiased) condition, the lumen 195 of the elongate laser cut hypotube 180 is aligned with the opening 205 of the rotary connector 200 and such that the elongate laser cut hypotube 180 and the rotary connector 200 can rotate as a unit. The end effector mounting portion 210 ( Figure 8 , Figure 9 , Figure 11 and Figure 12 ) is mounted to the rotary connector 200 such that when the rotary connector 200 rotates (i.e., when the elongate laser cut hypotube 180 rotates), the end effector mounting portion 210 rotates. The end effector 30 is mounted to the end effector mounting portion 210 (see below). The rotary connector 200 and the end effector mounting portion 210 are rotatably mounted to the body 105 of the distal articulation assembly 70 ( Figure 5 ) via the collar 170 ( Figure 5 and Figure 7 ). More particularly, the rotary connector 200 ( Figure 9 ) is rotatably mounted to the collar 170 and is capable of rotating relative to the collar 170. The end effector mounting portion 210 is mounted to the rotary connector 200 and engages the distal shoulder 215 ( Figure 10 ) of the rotary connector 200. The collar 170 is fixedly mounted to the body 105 of the distal articulation assembly 70 ( Figure 7 ). Thus, the end effector mounting portion 210 ( Figure 9 ) is fixedly mounted to the rotary connector 200, the rotary connector 200 in turn being fixedly connected to the elongate laser cut hypotube 180, and the foregoing sub-assemblies (the end effector mounting portion 170, the rotary connector 200, and the elongate laser cut hypotube 180) are rotatably mounted to the collar 170, the collar 170 being fixedly mounted to the distal articulation assembly 70 ( Figure 5 ), and the elongate laser cut hypotube 180 extends through the central aperture 150 of the flexure ridge 80 and through the aperture 100 of the body 85 of the proximal articulation assembly 75 (Figure 18 )。

[0235] 2.3 End Effector 30

[0236] The end effector 30 can take many different forms (e.g., a gripper, an injection needle, scissors, a thermal dissector, a monopolar probe, a hemostatic clip, a bipolar forceps, a suction tube, a single-shot or multi-shot closure device such as staples and a stapler, a dissecting forceps, a retrieval basket, a monopolar scissors, a monopolar knife, a monopolar knife with irrigation capabilities, etc.). For the sake of clarity of illustration, the end effector 30 is shown as a gripper in the figures.

[0237] In a preferred form of the present invention, and now referring Figure 8 to, the end effector 30 is mounted to the end effector mounting portion 210. More particularly, in a preferred form of the present invention, the end effector 30 includes a gripper having two opposing jaws 216, 217, and the jaws 216, 217 are pivotally mounted to the end effector mounting portion 210 via a pin 217A that passes through holes 217B in the jaws 216, 217 and through a hole 217C in the end effector mounting portion 210. As will be discussed below, the U-shaped clip 218 is mounted to the jaws 216, 217 via a pin 218A disposed in a slot 218B formed in the proximal portions of the jaws 216, 217 such that reciprocation of a wire (see below) mounted to the U-shaped clip 218 causes the opposing jaws 216, 217 of the gripper to open and close relative to each other.

[0238] 2.4 Overview of Articulating Devices

[0239] As discussed above, the shaft 15 also includes (i) means for selectively articulating the distal articulating portion 25 ( Figure 2 ) relative to the flexible proximal portion 20, (ii) means for selectively rotating the rotatable housing assembly 165 ( Figure 9 ) relative to the shaft 15 and thus for selectively rotating the end effector 30 relative to the shaft 15, and (iii) means for selectively actuating the end effector 30 ( Figure 8 ). As will be discussed below, all of the foregoing means are actuated via the handle 10.

[0240] More particularly, and now referring Figure 13 to Figure 14 and, the shaft 15 generally includes; (i) four articulating cables 220 for selectively articulating the distal articulating portion 25 relative to the distal end of the flexible proximal portion 20; (ii) an HHS coil 225 (e.g., a hollow helical strand of the type sold by Fort Wayne Metals of Fort Wayne, Indiana) for rotating the rotatable housing assembly 165 (Figure 9 )rotates selectively relative to the shaft 15 and is thus used to rotate the end effector 30 selectively relative to the shaft 15; and (iii) a wire 230, which is used to actuate the end effector 30 selectively.

[0241] 2.4.1 Articulating Cable 220

[0242] Next observe Figures 13-16 , in a preferred form of the present invention, four hinge cables 220 extend from the handle 10 to the distal seat portion 135 of the distal hinge joint assembly 70 ( Figure 15 and Figure 16 ), the hinge cables 220 pass through the holes 95 in the body 85 ( Figure 6 ), through the openings 145 in the flexure ridges 80 ( Figure 5 ) and extend to the distal seat portion 135 of the body 105 ( Figure 16 ). The hinge cables 220 are preferably each slidably disposed within a hinge cable housing 235 ( Figure 13 ). The distal end 240 of the hinge cable housing 235 (i.e., as will be discussed below, via the threaded adjuster 330) is mounted to the body 85 of the proximal hinge joint assembly 75 ( Figure 15 ). The hinge cable housing 235 bears against the body 85 of the proximal hinge joint assembly 75 and provides a reaction force to the body 85 to articulate the distal articulated portion 25 of the shaft 15 relative to the flexible proximal portion 20 of the shaft 15. The hinge cable housing 235 also separates the hinge cables 220 from each other and from the HHS coil 225, and helps to ensure smooth sliding movement of the hinge cables 220 within the flexible proximal portion 20 of the shaft 15 (i.e., over the distance between the handle 10 and the proximal hinge joint assembly 75, which can be substantially (e.g., 95 cm - 140 cm) in length and follows a serpentine path when the medical device 5 is disposed within a patient). If desired, to facilitate mounting the distal end of the hinge cable housing 235 to the body 85 ( Figure 15 ), the proximal end of each hole 95 may include a counterbore (not shown) sized to receive the distal end 240 of a given hinge cable housing 235.

[0243] Now observe Figure 15 and Figure 16 , after the hinge cables 220 pass distally through the openings 145 in the flexure ridges 80 ( Figure 5 ), the hinge cables 220 are attached (e.g., by welding, crimping, etc.) to the distal seat portion 135 of the body 105 of the distal hinge joint assembly 70. By way of example and not limitation, two of the hinge cables 220 may be provided by a single length of cable having a tube 245 crimped to the cable ( Figure 16), and tube 245 is welded (or otherwise affixed) to distal seat 135.

[0244] Due to this configuration, by selectively pulling proximally on the proximal end of the articulation cable 220, the body 105 ( Figure 7 ) can be articulated laterally, thereby articulating the distal articulation portion 25 of the shaft 15. In addition, by providing at least three articulation cables 220, three or more articulation cables are positioned around the circumference of the body 105, so that substantially universal articulation of the distal articulation coupling assembly 70 can be achieved, thereby providing substantially universal articulation for the distal articulation portion 25 of the shaft 15.

[0245] 2.4.2 HHS Coil 225

[0246] Next, observe Figure 13 , Figure 14 as well as Figure 17 , the HHS coil 225 includes a distal end 250 ( Figure 17 ), near end 255( Figure 26 ) and an inner cavity 260 ( Figure 13 To facilitate the rotation of the HHS coil 225 within the shaft 15, the HHS coil 225 is preferably disposed within a flexible friction reducing sleeve 267 ( Figure 13 ) within. More particularly, the HHS coil 225 preferably includes a plurality of filaments that are wound and swaged together so as to form together a hollow tubular structure. By way of example and not limitation, the HHS coil 225 may include a hollow helical strand of the type sold by Fort Wayne Metals of Fort Wayne, Indiana. In a preferred form of the invention, the HHS coil 225 includes 10 filaments that are wound together and swaged into a single flexible structure. The distal end 250 ( Figure 17 ) through the sleeve (or crimping piece) 265 ( Figure 17 ) to be mounted to the rotatable housing assembly 165 ( Figure 9 )'s long laser cut hypotube 180( Figure 17), such that when the HHS coil 225 rotates, the elongate laser cut hypotube 180 rotates (and thus, the end effector mounting portion 210 carrying the end effector 30 rotates). It will be appreciated that due to this configuration, by selectively rotating the HHS coil 225, thereby rotating the elongate laser cut hypotube 180 and thus rotating the end effector mounting portion 210 to which the end effector 30 is fastened, the rotational setting of the end effector 30 can be adjusted. Significantly, by using the HHS coil 225 and the elongate laser cut hypotube 180 to transmit torque along the shaft 15, any accumulation of torsional spring energy within the shaft is minimized even when the shaft 15 follows a serpentine path and the distal articulation portion 25 has been articulated relative to the longitudinal axis of the shaft 15.

[0247] 2.4.3 Pull Wire 230

[0248] Next observe Figure 13 、 Figure 14 、 Figure 18 and Figure 19 , a pull wire 230 is provided to selectively actuate the end effector 30. The distal end of the pull wire 230 ( Figure 19 ) is fastened to the U-bolt 218 of the end effector 30, the U-bolt 218 is slidably mounted to the jaws 216, 217 of the end effector 30, and the jaws 216, 217 are pinned to the end effector mounting portion 210 such that reciprocation of the pull wire 230 causes the opposing jaws 216, 217 of the end effector 30 to open and close relative to each other.

[0249] 2.5 More Details about the Structure of Shaft 15

[0250] When the shaft 15 is fully assembled, and now observing Figures 18-23 , the body 85 ( Figure 6 ) of the proximal articulation coupling assembly 75 ( Figure 18 ) is mounted to the distal end 40 ( Figure 2 ) of the flexible outer coil 35, the distal end 240 ( Figure 15 ) of the articulation cable housing 235 is mounted to the body 85 of the proximal articulation coupling assembly 75, and the articulation cable 220 passes through a hole 95 ( Figure 6 ) formed in the body 85. By mounting the proximal end 125 of the short laser cut hypotube 115 in a counterbore 102 ( Figure 6 ) in the body 85, the distal articulation coupling assembly 70 ( Figure 7 ) is mounted to the proximal articulation coupling assembly 75. The flexible body 140 ( Figure 5 ) of the flexure ridge 80 is "sandwiched" between the body 105 ( Figure 7 ) of the distal articulation coupling assembly 70 and the body 85 ( Figure 6), the distally extending finger 90 of the body 85 is disposed on the proximal seat 155 ( Figure 5 ), and the proximally extending finger 137 of the body 105 is disposed in the distal seat 160 of the flexion spine 80. The short laser cut hypotube 115 ( Figure 7 ) through the central hole 150 of the flexible body 140 of the flexure ridge 80 ( Figure 5 When the articulation cable 220 is pulled proximally, the distal end of the short laser-cut hypotube 115 presses against the body 85 of the proximal articulation coupling assembly 75 (which in turn presses against the articulation cable housing 235), thereby causing the distal articulation portion 25 of the shaft 15 to selectively articulate.

[0251] The elongated laser cut hypotube 180 ( Figure 9 , Figure 10 as well as Figure 17 ) extends proximally through a short laser cut hypotube 115 ( Figure 18 ), so that the proximal end 190 ( Figure 17 ) through the body 85 of the proximal hinge joint assembly 75 (i.e., by the counterbore 102 and the central hole 100 through the body 85), and is secured to the HHS coil 225 (e.g., via the sleeve 265) Figure 17 ). Rotatable housing assembly 165 ( Figure 9 ) of the collar 170( Figure 18 ) is mounted to the body 105 of the distal articulation coupling assembly 70 and covers the distal seat 135 (and the portion of the articulation cable 220 mounted to the distal seat 135). Figure 9 and Figure 10 ) is mounted to the distal end of the long laser cut hypotube 180. The rotary connector 200 is also mounted to the end effector mount 210. The end effector 30 is mounted to the end effector mount 210. Due to this configuration, when the HHS coil 225 rotates, the long laser cut hypotube 180 rotates, and the rotary connector 200 rotates, and the end effector mount 210 rotates, thereby causing the end effector 30 to rotate.

[0252] Pull 230( Figure 18 ) extends distally through the HHS coil 225 ( Figure 13 and Figure 14 ) and extends distally through the lumen 195 ( Figure 9 ), exit the rotary connector 200. The distal end of the pull wire 230 is connected to the end effector 30. Due to this configuration, the reciprocating movement of the pull wire 230 causes the opposite jaws 216, 217 (Figure 8 ) open and close relative to each other.

[0253] The flexible proximal portion 20 of the shaft 15 is preferably covered with a protective sleeve or outer covering (e.g., Pebax®) 270 ( Figure 18 , Figure 20 as well as Figure 21 ) is covered, the proximal end of the protective sleeve or outer covering 270 is fastened (e.g., bonded) to the rigid tube 60, and the distal end of the protective sleeve or outer covering 270 is fastened (e.g., bonded) to the body 85 of the proximal articulation coupling assembly 75, and the distal articulation portion 25 of the shaft 15 is preferably covered with the protective sleeve or outer covering 275 ( Figure 18 and Figure 22 ) is covered, the proximal end of the protective sleeve or outer covering 275 is fastened to the body 85 of the proximal articulated connection assembly 75, and the distal end of the protective sleeve or outer covering 275 extends all the way to the proximal portion of the end effector 30 and extends beyond the proximal portion of the end effector 30, thereby protecting the shaft 15 and allowing the shaft 15 to be easily inserted into the patient's body through a natural body orifice, a cannula, the inner cavity of another surgical instrument, etc.

[0254] As will be discussed in more detail below, the proximal end of the shaft 15 is mounted to the handle 10 ( Figure 1 ) so that the articulation cable 220, the HHS coil 225, and the pull wire 230 can be selectively actuated using the handle 10.

[0255] 3 Overview of Handle 10

[0256] Watch Now Figures 24-26 The handle 10 generally includes: an internal cavity 280; an articulation control assembly 285, which is used to selectively move the articulation cable 220 (and thereby selectively articulate the distal articulation portion 25 of the shaft 15); a push rod lock assembly 290, which is used to selectively lock the articulation control assembly 285 in a desired position (and thereby lock the distal articulation portion 25 of the shaft 15 in a selected position); a rotation control assembly 295, which is used to selectively rotate the HHS coil 225 (and thereby selectively rotate the end effector 30); and a trigger assembly 300, which is used to selectively actuate the pull wire 230 (and thereby selectively actuate the end effector 30).

[0257] 3.1 Articulation Control Assembly 285

[0258] Watch Now Figures 27-36 The articulation control assembly 285 generally includes: a ball plate 305 ( Figure 28), which is fixedly mounted within the internal cavity 280 of the handle 10, a thumb joystick ball assembly 310, which is configured to selectively pivot relative to the ball plate 305; and a thumb joystick 315, which is configured to be engaged by the user's thumb.

[0259] As will be discussed in more detail below, the ball plate 305 includes a plurality of threaded openings 320 ( Figure 28 ) and a central opening 325 for receiving the push rod lock assembly 290. The threaded opening 320 is configured to receive a plurality of threaded adjusters 330 ( Figure 29 and Figure 30 ), the threaded adjuster 330 is in turn mounted to the proximal end of each articulation cable housing 235 ( Figure 21 and Figure 30 ). It will be appreciated that, due to this configuration, the proximal end of the articulation cable housing 235 presses against the ball plate 305 (which in turn is fixedly mounted to the handle 10) so that when the articulation cable 220 is pulled proximally, the articulation cable housing 235 can provide a reaction force to the body 85 of the proximal articulation coupling assembly 75. As will be discussed below, each threaded adjuster 330 includes a central lumen passing through the threaded adjuster 330 so that the articulation cable 220 ( Figure 30 ) can be passed through a threaded adjuster to be mounted to the thumbstick ball assembly 310 (and therefore through the threaded opening 320 of the ball plate 305). Figure 30 ) is formed on (or attached to) the proximal end of each articulation cable 220, thereby facilitating mounting of the articulation cables 220 to the thumb joystick ball assembly 310. As will be discussed in more detail below, the ball plate 305 also includes a proximally facing concave recess 340 ( Figure 29 ), the recessed recess 340 is used to provide a space for the thumb joystick ball assembly 310, and the thumb joystick ball assembly 310 is pivotally disposed in a seat 342 set in the internal cavity 280 of the handle 10.

[0260] The thumbstick ball assembly 310 includes a hemispherical distal ball 345 ( Figure 32 ) and a hemispherical proximal ball 350. The hemispherical distal ball 345 preferably has a maximum diameter (i.e., a diameter at its proximal end) that is larger than the maximum diameter (i.e., a diameter at its distal end) of the hemispherical distal ball 345, thereby providing a proximal circumferential seat 355 ( Figure 31 As will be discussed in more detail below, the plurality of openings (or grooves) 360 ( Figure 31 ) is formed in the proximal circumferential seat 355 so as to receive the articulation cable 220 when the enlarged portion 335 is seated on the proximal circumferential seat 355. Due to this configuration, when the rounded distal end of the hemispherical distal ball 345 is pivotally disposed on the handle 10 ( Figure 27) within the seat 342 in the internal cavity 280 and separated from the ball plate 305 ( Figure 33 ) When separated, when the expansion portion 335 is placed on the proximal circumferential seat portion 355, the hinge cable 220 can pass through the opening (or groove) 360 in the proximal circumferential seat portion 355. Therefore, by selectively pivoting the hemispherical distal ball 345 within its seat 342 inside the internal cavity 280 of the handle 10 (i.e., by selectively pivoting the thumb lever 315, as will be discussed in more detail below), the hinge cable 220 can be selectively moved.

[0261] The thumb lever 315 includes a threaded rod 362 ( Figure 33 ) and a thumb seat 363. The distal end of the threaded rod 362 fastens the hemispherical proximal ball 350 to the hemispherical distal ball 345. The thumb seat 363 is fastened to the proximal end of the threaded rod 362. Due to this configuration, the thumb lever 315 can be used to selectively move the hemispherical distal ball 345, thereby selectively moving the hinge cable 220, thereby selectively articulating the distal articulated portion 25 of the shaft 15 relative to the flexible proximal portion 20 of the shaft 15.

[0262] 3.1.1 Push Rod Lock Assembly 290

[0263] Next, observe Figure 27 、 28 and Figures 33-36 , the push rod lock assembly 290 generally includes: an actuating lever 365 ( Figure 33 ); a cam 370, which is mounted on the actuating lever 365; and a push rod lock assembly plate 375, which has a push rod 380, the push rod 380 is mounted on the push rod lock assembly plate 375 and extends proximally from the push rod lock assembly plate 375. The push rod 380 is preferably disposed within a sleeve 385. In a preferred form of the present invention, a spring 390 ( Figure 35 ) is disposed above the sleeve 385 to bias the push rod lock assembly plate 375 distally away from the ball plate 305 ( Figure 36 ). The push rod 380 is slidably disposed in the central opening 325 ( Figure 28 ) of the ball plate 305 and extends from the central opening 325 toward the thumb lever ball assembly 310 ( Figure 33) extends proximally. The actuating lever 365 and the cam 370 are rotatably mounted in the cavity 280 of the handle 10, and the cam 370 contacts the push rod lock assembly plate 375, so that the movement of the actuating lever 365 cams the push rod lock assembly plate 375 (and thus the push rod 380) proximally against the power of the spring 390, thereby causing the free end of the push rod 380 to engage the hemispherical distal ball 345, thereby locking the thumb control ball assembly 310 from moving. When the actuating lever 365 is moved in a second opposite direction, the cam 370 moves so as to allow the push rod lock assembly plate 375 (and thus the push rod 380) to move distally away from the hemispherical distal ball 345 under the power of the spring 390, thereby allowing free movement of the thumb control ball assembly 310. As a result, it will be appreciated that the push rod lock assembly 290 can be used to selectively lock the thumb lever ball assembly 310 in a desired position, thereby selectively locking the distal articulating portion 25 of the shaft 15 in a desired (eg, articulated) configuration.

[0264] 3.2 Rotation Control Assembly 295

[0265] Next, observe Figures 37-41 The rotation control assembly 295 generally includes a rotation knob 395 ( Figure 37 and Figure 38 ), the rotating knob 395 has a rotating key 405 and a keyway 400 ( Figure 38 ). The rotation key 405 includes a distal end 406, a proximal end 407, and a lumen 408 extending therebetween. The HHS coil 225 is received within the lumen 408 of the rotation key 405 and is secured to the rotation key 405 such that rotation of the rotation key 405 effects rotation of the HHS coil 225. As noted above, the HHS coil 225 is secured to the elongated laser cut hypotube 180, and the elongated laser cut hypotube 180 is secured to the end effector mount 210 such that rotation of the HHS coil 225 causes rotation of the elongated laser cut hypotube 180, which causes rotation of the end effector mount 210 (and thus rotation of the end effector 30). The distal end 406 of the rotation key 405 is received in the keyway 400 of the rotation knob 395 such that the rotation key 405 is engaged by the rotation knob 395 and rotates when the rotation knob 395 is rotated. Due to this configuration, rotation of the turning knob 395 causes rotation of the turning key 405, which causes rotation of the HHS coil 225 and thus rotation of the end effector 30. In a preferred form of the invention, the keyway 400 of the turning knob 395 includes a non-circular cross-sectional profile that matches the non-circular cross-sectional profile of the distal end 406 of the turning key 405.

[0266] The rotation knob 395 is rotatably mounted in the cavity 280 of the handle 10 so that a portion of the rotation knob 395 is moved from the handle 10 ( Figure 37)projects outwardly, thereby allowing the rotary knob 395 to be selectively rotated by the user. As will be discussed below, a pull wire 230 disposed within the HHS coil 225 ( Figure 40 )extends through the rotary key 405 and is selectively actuated using the trigger assembly 300 ( Figure 25 ).

[0267] The proximal end 407 of the rotary key 405 extends outwardly from the rotary knob 395 ( Figure 39 ). In a preferred form of the present invention, the proximal end 407 of the rotary key 405 ( Figure 38 )includes a plurality of teeth 409 for releasably engaging a ball head spring plunger 410 ( Figure 41 ). The ball head spring plunger 410 is mounted within a cavity 280 of the handle 10 such that the ball head spring plunger 410 releasably engages the teeth 409 disposed on the proximal end 407 of the rotary key 405. By virtue of the engagement between the ball head spring plunger 410 and the rotary key 405, the rotary key 405 (and thus, the HHS coil 225 mounted to the rotary key 405) is prevented from "spontaneously" rotating without deliberately rotating the rotary knob 395. Thus, the ball head spring plunger 410 prevents the accumulated spring tension (e.g., the spring tension that can accumulate when using the rotary knob 395 to rotate the HHS coil 225) from "unwinding" the HHS coil 225 and thereby causing an accidental rotation of the HHS coil 225 (and thus, an accidental rotation of the end effector 30).

[0268] 3.3 Trigger Assembly 300

[0269] Next observe Figures 42-46 、 Figure 46A 、 Figure 46B and Figure 47 , as will be discussed in more detail below, the trigger assembly 300 generally includes: a trigger 415 pivotally mounted to the handle 10; a carriage 420 ( Figure 43 )movably disposed within a cavity 280 of the handle 10; and one or more lever arms 425 connecting the trigger 415 to the carriage 420 such that when the trigger 415 is actuated (i.e., pulled), the carriage 420 moves proximally within the cavity 280 of the handle 10, thereby moving the pull wire 230 proximally, thereby actuating the end effector 30.

[0270] More particularly, the carriage 420 includes: a cavity 430 ( Figure 45 ); a distal bushing 435 ( Figure 46), which is disposed within the cavity 430, a proximal bushing 440, which is disposed within the cavity 430; and a spring 445, which is disposed between the distal bushing 435 and the proximal bushing 440. The inner support tube 450 (e.g., by a crimp sleeve 451 disposed at the proximal end of the inner support tube 450) is fastened to the pull wire 230. An outer support tube 452 is disposed over a distal portion of the inner support tube 450, and the inner support tube 450 is capable of sliding freely within the outer support tube 452. The outer support tube 452 further includes an outer support tube collar 453, and the outer support tube collar 453 is sized to be installed within a seat 454 formed within the inner cavity 280 of the handle 10 ( Figure 46B ). A spring 455 ( Figure 42 ) is disposed within the proximal end of the handle 10 to bias the slider 420 distally.

[0271] Due to this configuration, when the slider 420 moves proximally against the force of the spring 455 ( Figure 42 ), i.e., by pulling the trigger 415, the distal bushing 435 ( Figure 46 ) moves proximally, pressing against the spring 445, which in turn presses against the proximal bushing 440, which presses against the crimp sleeve 451 and pulls the pull wire 230 proximally. Thus, as the slider 420 moves proximally, the proximal bushing 440 and the crimp sleeve 451 also move proximally, thereby moving the pull wire 230 proximally and thereby actuating the end effector 30. However, it should be understood that since the slider 420 is not directly mounted to the pull wire 230, the proximal bushing 440 and the spring 445 act as force limiters, where the spring 445 yields when the force on the pull wire 230 exceeds a given level, thereby stopping the application of proximal force to the pull wire 230. In other words, if the force applied to move the slider 420 proximally exceeds the force that biases the proximal bushing 440 away from the distal bushing 435 (i.e., the biasing force provided by the spring 445), the spring 445 will compress, thereby allowing the proximal bushing 440 and the crimp sleeve 451 (and thus the inner support tube 450 and the pull wire 230) to remain stationary as the slider 420 moves proximally. In this way, the trigger 415 can be pulled through a "full stroke" without the risk of breaking the pull wire 230.

[0272] It should also be understood that since the spring 455 biases the slider 420 distally and since the crimp sleeve 451 is engaged by a shoulder 456 when the slider 420 moves proximally, the slider 420 will return to its distal position within the handle 10 and the pull wire 230 will move distally.

[0273] 4 Exemplary Method of Use

[0274] In an exemplary use of the novel medical device 5 in minimally invasive surgery, the profile of the end effector 30 is reduced (e.g., in the case where the end effector 30 includes a gripper, the jaws of the gripper are closed); the shaft 15 is straightened; the handle 10 is advanced longitudinally to facilitate the longitudinal advancement of the distal end of the medical device 5 through the access and (e.g., along a serpentine path) into the body; the handle 10 is advanced longitudinally and / or rotated, and / or the distal articulating portion 25 of the shaft 15 is bent, and / or the end effector 30 is rotated so that the end effector 30 appropriately manipulates the target tissue at the internal site; the end effector 30 is used to perform the desired surgery at the internal site (e.g., in the case where the end effector 30 includes a surgical gripper, the jaws of the gripper are opened and closed to grasp tissue); and the distal end of the medical device 5 is withdrawn from the body, e.g., the handle 10 is withdrawn longitudinally through the access (during which time, if necessary, the handle may also be rotated, and / or the distal articulating portion 25 of the shaft 15 is unbent and / or the end effector is rotated so that the end effector is withdrawn from the body).

[0275] It will be appreciated that the novel medical device 5 is capable of at least the following movements:

[0276] Movement 1 - Longitudinal movement of the end effector 30 achieved by longitudinal movement of the handle 10 (sometimes referred to herein as the "longitudinal movement function");

[0277] Movement 2 - Rotational movement of the end effector 30 achieved by rotational movement of the handle 10 (sometimes referred to herein as the "twisting movement function");

[0278] Movement 3 - Articulating movement of the end effector 30 relative to the handle 10 achieved by distal articulation of the distal articulating portion 25 of the shaft 15 relative to the distal end of the flexible proximal portion 20 of the shaft 15 (sometimes referred to herein as the "universal articulation function");

[0279] Movement 4 - Rotational movement of the end effector 30 relative to the distal end of the distal articulating portion 25 of the shaft 15 achieved by rotating the end effector 30 relative to the shaft 15 (sometimes referred to herein as the "rotation function"); and

[0280] Movement 5 - Actuation of the end effector 30, e.g., selectively moving the elements of the end effector 30 relative to each other to facilitate performing a medical procedure, e.g., opening and closing the jaws of a gripper-type end effector (sometimes referred to herein as the "jaw opening / closing function").

[0281] It will be understood by those skilled in the art that, if desired, the medical device may be modified to provide fewer (or more) movements than the five previously mentioned movements, e.g., the rotation function may be excluded, an additional rotational function (such as selective rotation of the shaft 15) may be added, etc.

[0282] 5 New Tool Support

[0283] Next, observe Figures 47-49 , which shows a novel tool support 460 that can be used to support the medical device 5. The tool support 460 generally includes: a clamp 465 for mounting the tool support 460 to the surgical table 466; an adjustable base 470 for mounting one or more medical devices 5 to the tool support 460; and an adjustable arm 475 ( Figure 48 ), which adjustably mounts the base 470 to the clamp 465. As will be discussed in more detail below, one or more instrument adapters 480 ( Figure 49 ) are mounted to the base 470, thereby allowing one or more medical devices 5 to be mounted to the tool support 460 (i.e., by providing a support for the handle 10 and / or the rigid tube 60 at the proximal end of the shaft 15).

[0284] As will be discussed in more detail below, one or more tool channels 485 (configured to pass the shaft 15 into the patient's body (or into the working lumen of another medical device)) are mounted to one or more instrument adapters 480.

[0285] More particularly, and still observing Figures 47-50 , as will be discussed below, the clamp 465 is configured to be mounted to a stable object (e.g., the surgical table 466) to allow the surgeon to manipulate the tool support 460 (and thus one or more medical devices 5 mounted to the tool support 460) relative to the patient and / or relative to other surgical instruments.

[0286] The adjustable arm 475 preferably includes one or more segments 490 ( Figure 49 ), which are adjustably mounted to each other and adjustably mounted to the clamp 465 and the base 470, thereby allowing the surgeon to precisely adjust the setting of the base 470 relative to the patient (and / or relative to another surgical instrument).

[0287] Now observe Figure 49 and Figure 50 , each instrument adapter 480 includes a mounting portion 495 and a tube 500. The mounting portion 495 is pivotally mounted to the base 470 ( Figure 49)。The tube 500 has a lumen 505 sized to receive the proximal end of the shaft 15 of the medical device 5 (i.e., the rigid tube 60 located at the proximal end of the shaft 15). If desired, the lumen 505 may include a diaphragm 515 for fluidly sealing the tube 500 (and thus for fluidly sealing the tool chamber 485), and / or the tube 500 may include an end cap 520 for fluidly sealing the tube 500 (and thus for fluidly sealing the tool chamber 485).

[0288] Now observe Figures 51-55 , which shows some exemplary configurations for the tool support 460. It should be understood that the base 470 of the tool support 460 may include a plurality of pivots and / or arms, may be shaped in an arcuate form, and / or may include other geometric configurations, etc., to accommodate the needs and / or preferences of the surgeon.

[0289] 6 Medical Device 5 with Rotatable Shaft 15

[0290] As discussed above, the novel medical device 5 includes a shaft 15 having a flexible proximal portion 20; a distal articulating portion 25 that is selectively articulable relative to the distal end of the flexible proximal portion 20; and an end effector 30 that is selectively rotatable relative to the distal end of the distal articulating portion 25. In this configuration, longitudinal movement of the handle 10 can be used to move the shaft 15 distally and proximally, thereby moving the end effector 30 distally and proximally; rotational movement of the handle 10 can be used to rotate the shaft 15, thereby rotating the end effector 30; the articulation control assembly 285 ( Figure 25 ) can be used to articulate the distal articulating portion 25 of the shaft 15, thereby steering the end effector 30; the rotation control assembly 295 ( Figure 25 ) can be used to rotate the end effector 30; and the trigger assembly 300 ( Figure 25 ) can be used to actuate the end effector 30. In the case of the foregoing configuration, the flexible proximal portion 20 and the handle 10 rotate together as a unit.

[0291] However, it has been recognized that it may be desirable to be able to rotate the flexible proximal portion 20 of the shaft 15 independently of the handle 10. To this end, and now observe Figures 56-58 , a novel rotatable shaft adapter mechanism 525 may be provided between the shaft 15 and the handle 10, thereby allowing the shaft 15 (i.e., both the flexible proximal portion 20 and the distal articulating portion 25) to selectively rotate relative to the handle 10.

[0292] More particularly, the rotatable shaft adapter mechanism 525 is mounted to the proximal end of the shaft 15 (i.e., to the proximal end of the flexible proximal portion 20) and connects the shaft 15 to the handle 10. It should be understood that in this form of the invention, the rotatable shaft adapter mechanism 525 replaces the previously mentioned shaft adapter 55 (where the previously mentioned shaft adapter 55 is fixedly fastened to the handle 10 and fixedly fastened to the proximal end of the outer coil 35, and where the rigid tube 60 is fixedly fastened to the shaft adapter 55). More particularly, in this form of the invention, as will be discussed in more detail below, the shaft 15 is rotatably mounted to the distal end of the handle 10 and is selectively locked / unlocked from rotation via the rotatable shaft adapter mechanism 525.

[0293] Still observing now Figures 56-58 , in this form of the invention, the rigid tube 60 of the shaft 15 includes a flange 530 disposed around the proximal most end of the rigid tube 60. The flange 530 is received within a corresponding groove 535 formed in the distal end of the handle 10 (i.e., formed within the cavity 280 of the handle 10 near the most distal end of the handle 10), thereby rotatably mounting the rigid tube 60 of the shaft 15 to the handle 10. In this form of the invention, the proximal end of the outer coil 35 is fixedly fastened to the rigid tube 60 (and the distal end of the outer coil 35 is fastened to the body 85 of the proximal articulation linkage assembly 75). As will be discussed in more detail below, the outer circumference of the most distal end of the handle 10 includes a plurality of keyways 540 ( Figure 57 ), the keyways 540 being sized to receive a plurality of protrusions 542 formed on the rotatable shaft adapter mechanism 525. It is noted that if desired, the positions of the keyways 540 and the protrusions 542 may be reversed from the foregoing, i.e., the keyways 540 may be formed on the rotatable shaft adapter mechanism 525 and the protrusions 542 may be formed on the most distal end of the handle 10.

[0294] The rotatable shaft adapter mechanism 525 generally includes a shaft rotation knob 545 having an inner cavity 550 extending therethrough. The inner cavity 550 includes a distal end 555, a proximal end 560, and an annular shoulder 565 disposed therebetween. A spring 570 is disposed within the distal end 555 of the inner cavity 550, between the annular shoulder 565 and a retaining cap 580 circumferentially mounted around the outer perimeter of the shaft 15 ( Figure 58 , Figure 58A , Figure 58B , Figure 58C , and Figure 58D) extends between the proximal ends 575 thereof, thereby biasing the shaft rotation knob 545 proximally such that the protrusion 542 of the shaft adapter mechanism 525 is received within the keyway 540 of the handle 10, thereby locking the shaft rotation knob 545 against rotation. More particularly, the retaining cap 580 includes a pair of flat portions 585 that are keyed to corresponding flat portions 590 formed on the outer surface of the rigid tube 60 of the shaft 15. One or more spring fingers 591 engage a groove 592 on the outer surface of the rigid tube 60, thereby locking the retaining cap 580 to the rigid tube 60. The retaining cap 580 also includes a plurality of key features 593 sized to be received within corresponding keyways 594 of the shaft rotation knob 545. Due to this construction, the rotation knob 545 is capable of longitudinally sliding (distally or proximally) relative to the rigid tube 60 of the shaft 15. However, the rotation knob 545 is locked against rotation relative to the rigid tube 60 (and thus relative to the shaft 15). Thus, the rotation knob 545 can be longitudinally moved without causing longitudinal movement of the rigid tube 60 and the shaft 15, but rotation of the rotation knob 545 will be transferred to the rigid tube 60 (and as will be discussed below, to the shaft 15).

[0295] The shaft rotation knob 545 is connected (e.g., via a protrusion, friction fit, etc.) to the rigid tube 60 of the shaft 15 such that the shaft rotation knob 545 is longitudinally movable relative to the rigid tube 60 but is rotationally fixed to the rigid tube 60.

[0296] In this form of the invention, the proximal end of the protective sleeve or outer covering (e.g., Pebax®) 270 is fastened (e.g., bonded) to the rigid tube 60, and the distal end of the protective sleeve or outer covering 270 is fastened (e.g., bonded) to the body 85 of the proximal articulation assembly 75. Significantly, the protective sleeve or outer covering 270 is capable of transmitting torque between the rigid tube 60 and the body 85 of the proximal articulation assembly 75.

[0297] Due to this construction, the spring 570 normally biases the shaft rotation knob 545 proximally, thereby causing the projection 542 to engage the keyway 540 and locking the shaft 15 against rotation relative to the handle 10. However, when the shaft rotation knob 545 moves distally against the force of the spring 570, the projection 542 disengages from the keyway 540, thereby allowing the shaft rotation knob 545 to rotate selectively relative to the handle 10, thereby allowing the rigid tube 60 to rotate selectively relative to the handle 10, thereby allowing the protective sleeve or outer covering 270 to rotate selectively relative to the handle 10, thereby allowing the body 85 of the proximal hinge coupling assembly 75 to rotate selectively, thereby allowing the distal hinge portion 25 of the shaft 15 to rotate selectively relative to the handle 10. When the shaft 15 has rotated relative to the handle 10 to the desired position, the shaft rotation knob 545 is released, and the shaft rotation knob 545 moves proximally under the force of the spring 570 such that the projection 542 re-engages the keyway 540, thereby locking the shaft 15 against further rotation relative to the handle 10.

[0298] Thus it will be seen that in this form of the invention, the rigid tube 60 is rotatable relative to the handle 10 but longitudinally fixed relative to the handle 10; the shaft rotation knob 545 is connected to the rigid tube 60 such that the shaft rotation knob 545 is longitudinally movable relative to the rigid tube 60 but not rotationally movable relative to the rigid tube 60, such that the shaft rotation knob 545 can be selectively locked to or unlocked from the handle 10 to facilitate allowing the shaft rotation knob 545 to rotate the rigid tube 60 selectively; and the protective sleeve or outer covering 270 transmits torque between the rigid tube 60 and the body 85 of the proximal hinge coupling assembly 75 such that rotation of the rigid tube 60 causes rotation of the body 85 of the proximal hinge coupling assembly 75, thereby rotating the distal hinge portion 25 of the shaft 15 relative to the handle 10.

[0299] It will be appreciated that unrestricted rotation of the rigid tube 60 and the shaft 15 will cause the hinge cable 220 and the hinge cable housing 235 to wrap around themselves; thus, in a preferred form of the invention, means are provided for restricting the rotation of the rigid tube 60 and the shaft 15. More particularly, in a preferred form of the invention, and now observing Figure 58E and Figure 58F , the rigid tube 60 of the shaft 15 preferably includes a groove 595 extending circumferentially partially around the outer surface of the shaft 15. The groove 595 is provided only distally of the proximal end of the shaft 15 and extends partially but not completely around the circumference of the shaft 15. A corresponding boss 596 is formed on the distal end of the handle 10 and is received within the groove 595. Due to this construction, the shaft 15 can only be rotated until the boss 596 reaches one end of the groove 595. In a preferred form of the invention, the groove 580 is sized such that the shaft 15 can be rotated up to 350 degrees.

[0300] 7 Additional Structure

[0301] In the foregoing disclosure, a novel medical device 5 was described. The novel medical device 5 includes a handle, an elongate flexible shaft, and an end effector disposed at a distal end of the shaft configured to perform a medical procedure. It should be understood that the medical device 5 can be modified in a variety of ways to support different types of end effectors, to facilitate single-handed use of the medical device 5, to enhance the functionality of the medical device 5, and the like.

[0302] 7.1 Alternative End Effector

[0303] As discussed above, in a preferred form of the present invention, the end effector 30 includes a surgical grasper having two opposing jaws 216, 217 ( Figure 8 ).

[0304] In another preferred form of the present invention, and now observing Figures 59-62 , the end effector 30 includes scissors 600 having opposing blades 605, 610. The blades 605, 610 include sharp edges that contact each other when the blades 605, 610 are brought together (i.e., closed) to facilitate cutting (e.g., cutting tissue, sutures, etc.). To ensure precise cutting by the blades 605, 610, it is desirable to maintain the blades 605, 610 in close contact with each other when the blades 605, 610 are brought together (i.e., closed). To this end, bevel washers 615 ( Figure 61 and Figure 62 ) are disposed between one of the blades 605, 610 and the inner wall of the end effector mounting portion 210. The bevel washer 615 is preferably disposed on top of a pin 217A that pivotally mounts the blades 605, 610 to the end effector mounting portion 210. By mounting the bevel washer 615 in this way, the blades 605, 610 remain in close engagement when the blades 605, 610 are brought together (i.e., closed), thereby facilitating precise cutting (e.g., cutting tissue, sutures, etc.).

[0305] 7.2 Finger slider for single-handed shaft rotation

[0306] As discussed above, in one form of the present invention, the shaft 15 is rotatably mounted to the distal end of the handle 10 and can be selectively rotated using a rotatable shaft adapter mechanism 525 ( Figures 56 - 58 and Figures 58A - 58F ). In the case of this form of the present invention, the proximal end of the shaft 15 (e.g., by means of the aforementioned flange 530 on the rigid tube 60 ( Figure 58)(which is rotatably received within the aforementioned corresponding recess 535 formed in the distal end of the handle 10) to) be rotatably mounted to the distal end of the handle 10, and the rotatable shaft adapter mechanism 525 is moved distally (i.e., is pushed distally by the user against the force of the spring 570) so as to “unlock” the shaft 15 (i.e., to allow the shaft rotation knob 545 to rotate and thus allow the shaft 15 to rotate). Then, the user can rotate the shaft 15 as desired (i.e., by rotating the rotatable shaft adapter mechanism 525 and thus rotating the shaft 15). After the user has rotated the shaft 15 as desired, the shaft adapter mechanism 525 is released and automatically moves proximally (i.e., is effected by the force of the spring 570) so as to “lock” the shaft 15 against further rotation. This action typically requires the user to use one hand to push the rotatable shaft adapter mechanism 525 distally (and thereafter rotate the shaft 15), while the user uses his other hand to hold the handle 10 stationary.

[0307] However, it should be understood that it may also be desirable for the user to rotate the shaft 15 with one hand. To this end, in another form of the present invention, the shaft 15 (e.g., via friction between the outer surface of the shaft 15 and the interior of the tool channel (e.g., the tool channel 485 ( Figure 48 ), the lumen of a tool channel provided in another medical device such as an endoscope, etc.)) is held stationary, the handle 10 is selectively rotationally disconnected from the shaft 15, and the handle 10 is selectively rotated by the user with one hand to a desired rotational position. Then, the handle 10 is rotationally reconnected to the shaft 15 and then rotated by the user (thereby also rotating the shaft 15).

[0308] More particularly, in the case of this form of the present invention, and now observing Figures 63 - 66 , as will be discussed in more detail below, a shaft rotation finger slide assembly 625 is provided to effect one-handed rotation of the shaft 15. The shaft rotation finger slide assembly 625 generally includes: a finger slide mechanism 630 that is slidably disposed within the handle 10; and a shaft collar 635 that is fixedly mounted to the proximal end of the shaft 15 (e.g., fixedly mounted to the rigid tube 60).

[0309] The finger slide mechanism 630 includes a saddle 640 having a pair of protrusions 645 that extend through corresponding slots (not shown) formed in the sidewall of the handle 10. A pair of finger slides 647 are fastened to the protrusions 645. As will be discussed in more detail below, a strut 650 extends distally from the saddle 640 and is configured to selectively lock the shaft collar 635 against rotation. As will be discussed in more detail below, a spring 655 biases the saddle 640 distally (and thus biases the strut 650 distally) such that when the finger slide mechanism 630 is in its rest state, the strut 650 engages the shaft collar 635.

[0310] The bushing collar 635 is fixedly mounted to the proximal end of the shaft 15 (e.g., to the rigid tube 60). The bushing collar 635 includes a distal end 660, a proximal end 665, and a lumen 670 extending therebetween. As will be discussed in more detail below, a plurality of teeth 675 are provided around the inner circumference of the lumen 670 at the proximal end 665 of the bushing collar 635, the teeth 675 being spaced apart such that the struts 650 of the finger slide mechanism 630 can be received within the gap between a pair of adjacent teeth 675, thereby locking the bushing collar 635 (and thus the shaft 15) against rotation.

[0311] When the user desires to rotate the shaft 15, the user moves the finger slider 647 proximally, thereby moving the projection 645 proximally, thereby moving the saddle 640 proximally against the force of the spring 655. When this occurs, the struts 650 also move proximally, thereby disengaging the struts 650 from the teeth 675 of the bushing collar 635 (and thus rotationally disconnecting the handle 10 from the shaft 15). While holding the projection 645 proximally, the user can then rotate the handle 10 relative to the shaft 15 as desired. When the handle 10 is rotated, the shaft 15 does not rotate (i.e., the shaft 15 is maintained stationary by friction between the outer surface of the shaft 15 and the interior of the lumen (e.g., the tool passage 485) within which the shaft 15 is disposed). After the user has rotated the handle 10 to the desired angle, the user releases the finger slider 647, which allows the projection 645 and the saddle 640 (and thus the struts 650) to move distally under the force of the spring 655, the struts 650 moving distally into the space between a pair of teeth 675 of the bushing collar 635, thereby rotationally reconnecting the handle 10 to the bushing collar 635 (and thus to the shaft 15). At this time, the user can rotate the handle 10 as desired in order to rotate the shaft 15. By way of example and not limitation, if the user desires to rotate the shaft 15 clockwise 90 degrees, the user can rotationally disconnect the shaft 15 from the handle 10 in the manner discussed above, rotate the handle 10 counterclockwise 90 degrees (e.g., rotate the grip of the handle 10 from the "6 o'clock" position to the "3 o'clock" position), reconnect the shaft 15 to the handle 10 in the manner discussed above, and then rotate the handle 10 (and thus the shaft 15) clockwise 90 degrees (e.g., rotate the grip of the handle 10 from the "3 o'clock" position to the "6 o'clock" position).

[0312] 7.3 Single-plane hinge mechanism

[0313] As discussed above, in a preferred form of the present invention, the articulation control assembly 285 includes a thumb joystick ball assembly 310 configured to selectively pull proximally one or more of the four articulation cables 220, thereby allowing the distal articulating portion 25 of the shaft 15 to selectively gimbal relative to the flexible proximal portion 20 of the shaft 15 via movement of the thumb joystick ball assembly 310.

[0314] However, it has been recognized that it is sometimes also desirable to provide a simplified articulation control assembly that can be used with only two articulation cables, for example to provide single-plane articulation of the distal articulating portion 25 of the shaft 15 relative to the flexible proximal portion 20 of the shaft 15. To this end, in one form of the present invention, and now referring Figures 67 - 69 to, an articulation control assembly 680 is shown, which, as will be discussed in more detail below, is similar to the articulation control assembly 285 discussed above but is configured to provide single-plane articulation.

[0315] More particularly, the articulation control assembly 680 includes a rocker 685 pivotally mounted within the internal cavity 280 of the handle 10. The rocker 685 can be pivotally mounted within the internal cavity 280 via a suitably formed seat disposed within the internal cavity 280 of the handle 10 or by other means (e.g., pivot pins). A thumb lever 690 is mounted to the rocker 685 and extends proximally through a slot 695 formed in the housing of the handle 10 ( Figure 69 ). A wedge-shaped thumb rest 700 is preferably mounted to the free end of the thumb lever 690. Two articulation cables 220 (not shown) are mounted to the rocker 685 (e.g., by mounting the proximal ends of the articulation cables 220 within diametrically opposed slots 705 formed in the rocker 685).

[0316] Due to this configuration, the user can selectively articulate the distal articulating portion 25 of the shaft 15 in a single plane by selectively moving the thumb lever 690, thereby selectively pivoting the rocker 685 in a single plane and thereby selectively pulling proximally one of the two articulation cables 220 mounted to the rocker 685.

[0317] 7.4 HHS coil including a compressible outer wrap

[0318] As discussed above, the pull wire 230 is disposed within the internal cavity 260 of the HHS coil 225 and is capable of sliding freely relative to the HHS coil 225 to selectively actuate the end effector 30 (i.e., when the user pulls the trigger 415 of the handle 10, thereby moving the pull wire 230 proximally).

[0319] It has been found that, since the shaft 15 (and thus the HHS coil 225) can extend a relatively long distance along a tortuous path (e.g., through a patient's colon), the HHS coil 225 can sometimes be longitudinally compressed (i.e., longitudinally shortened), while the pull wire 230 is not longitudinally compressed (i.e., longitudinally shortened). When this occurs, since the HHS coil 225 provides a reaction force to the pull wire 230, the pull wire 230 needs to move a greater distance proximally in order to actuate the end effector 30. However, if the trigger 415 has reached the end of its "pull distance" (i.e., if the trigger 415 cannot be pulled further), further proximal movement of the pull wire 230 may not be possible.

[0320] To minimize longitudinal compression of the HHS coil 225, and now observing Figures 70 - 72 , in one form of the present invention, a flat wound coil 710 is provided, which is wound around the HHS coil 225. The flat wound coil 710 is welded to the distal end 250 of the HHS coil 225 and to the proximal end 255 of the HHS coil 225. The coil 710 rotates with the HHS coil 225 and provides support to the HHS coil 225, thereby minimizing longitudinal compression of the HHS coil 225. Due to this configuration, when the shaft 15 is disposed along a tortuous path, the HHS coil 225 is not longitudinally compressed (i.e., the HHS coil 225 does not shorten).

[0321] 7.5 Cover for end effector mounting portion 210

[0322] As discussed above, the end effector 30 can be pivotally mounted within the end effector mounting portion 210 via the pin 217A, which passes through the jaws 216, 217 of the end effector and the gripper.

[0323] However, in the case of certain end effectors, it is necessary to provide an opening in the side of the end effector mounting portion 210 such that when the end effector is in certain configurations, the proximal ends of the elements of the end effector have room to move. By way of example and not limitation, and now observing Figure 73 and Figure 74 , in one form of the present invention, the end effector 30 includes scissors. More particularly, in this form of the present invention, the end effector 30 includes: a first blade 715 having a distal end 720 and a proximal end 725; and a second blade 730 having a distal end 735 and a proximal end 740. The first blade 715 and the second blade 730 are pivotally mounted to each other and to the end effector mounting portion 210 via a pin 745. When the first blade 715 and the second blade 730 are opened (i.e., to receive tissue, suture, etc. to be cut), the proximal end 725 of the first blade 715 and the proximal end 740 of the second blade 730 move away from the end effector mounting portion 210 ( Figure 73)Project laterally outwardly. It has been found that the proximal ends 725, 740 may present sharp surfaces which, when the end effector 30 is used in surgery, particularly when the blades 715, 730 are in their open positions, may damage surrounding equipment and / or anatomy when the end effector 30 rotates at the surgical site. To address this issue, a cover 750 may be provided which covers the proximal portion of the end effector mounting 210. As a result, even when the blades 715, 730 are in their open positions, the proximal ends 725, 740 of the blades 715, 730 remain covered, thereby preventing damage to the anatomy or other surgical equipment. In a preferred form of the present invention, the cover 750 is formed from an electrically insulating material such that the cover 750 also provides electrical insulation. This may be advantageous in cases where the end effector 30 includes monopolar scissors or the like.

[0324] 7.6 Enhanced handle and trigger ergonomics

[0325] As discussed above, in a preferred form of the present invention, the trigger 415 ( Figure 25 ) is pivotally mounted to the handle 10 and can be selectively pulled by the user in order to selectively actuate the end effector 30. For purposes of illustration, the trigger 415 is shown in Figure 25 as a conventional "pistol grip" trigger and the handle 10 is shown as including a conventional "pistol grip".

[0326] However, it has been found that it is sometimes desirable to provide additional stabilizing elements on the handle 10 (e.g., to facilitate single-handed use of the medical device 5), and / or to provide a trigger with a longer pull distance (i.e., an increased arc of movement) in order to provide better leverage.

[0327] To this end, and now observing Figure 75 and Figure 76 , in one form of the present invention, the handle 10 includes: a "pinky" stabilizer ring 755 for receiving the user's "pinky" finger and a "hook lever" type trigger 760 for providing the user with greater leverage and improved ergonomics. This configuration facilitates better single-handed gripping of the handle 10 by the user and also allows the user to easily move the trigger 415 proximally or distally (e.g., to pull or push the cable 230 in order to selectively close / open the jaws of the gripper, etc.).

[0328] 7.7 Monopolar current delivery

[0329] In some situations, it is desirable to be able to deliver monopolar electrical power to end effector 30. By way of example and not limitation, where end effector 30 comprises monopolar ("hot") scissors, it may be necessary to transmit electrical power from handle 10 along (or through) shaft 15 to end effector 30.

[0330] For this reason, and now observe Figures 77 - 80 In a preferred form of the invention, there are provided: an electrical connection port (e.g., a "banana plug") 765 disposed on the proximal end of the grip of the handle 10 for connection to an external power supply (not shown); and an electrical wire 770 ( Figure 79 ), which is disposed in the internal cavity 280 of the handle 10 so as to guide the electrical power from the electrical connection port 765 to the handle 10 ( Figure 80 ). The flat conductive spring 775 contacts a plurality of teeth 409 disposed on the rotation key 405, thereby making electrical contact with the rotation key 405, and thus making electrical contact with the HHS coil 225 and / or the pull wire 230 via the rotation key 405. It should be understood that, in the case of this form of the invention, the ball head spring plunger 410 is preferably omitted (i.e., it is replaced by the flat conductive spring 775). In addition, in the case of this form of the invention, the rotation key 405 (and the teeth 409 of the rotation key 405) are formed of a conductive material (e.g., metal), as are the elongated laser cut hypotube 180, the rotary connector 200, and the end effector mounting portion 210. As a result, electrical power may be transferred from an external power supply (not shown) to the electrical connection port 765, along the electrical wire 770 to the flat conductive spring 775, from the conductive spring 775 to the rotation key 405, and then to the HHS coil 225 (and also to the pull wire 230), along the HHS coil 225 (and the pull wire 230) through the flexible proximal portion 20 of the shaft 15, through the sleeve (or crimp) 265 to the elongated laser cut hypotube 180, along the elongated laser cut hypotube 180 (and the pull wire 230) through the distal articulation portion 25 of the shaft 15 to the rotary connector 200 and the end effector mount 210, and from the end effector mount 210 to the end effector 30. In this way, monopolar power may be supplied to the end effector 30.

[0331] 7.8 Alternative end effectors

[0332] As discussed above, in a preferred form of the invention, the end effector 30 includes a jaw assembly having two opposing jaws 216, 217 ( Figure 8 ) surgical grasper, in another preferred form of the present invention, the end effector 30 includes a surgical grasper having opposite blades 605, 610 ( Figures 59 - 62) scissors 600, and in another preferred form of the present invention, the end effector 30 includes monopolar ("hot") scissors, and the handle 10 is modified to transmit electrical power from the handle 10 along (or through) the shaft 15 to the end effector 30( Figures 77 - 80 ).

[0333] In yet another preferred form of the present invention, and now observing Figures 81 - 98 , the end effector 30 includes a monopolar knife assembly 800, the monopolar knife assembly 800 includes a knife tip, which can be energized for use in marking tissue, cutting tissue, and / or cauterizing tissue. More particularly, the knife assembly 800 includes a knife 805, a knife housing 820, and a pull wire 230 for: (i) delivering monopolar electrical power to the knife 805 to energize the knife 805; and (ii) moving the knife 805 distally and proximally, thereby extending and retracting the knife 805 relative to the knife housing 820.

[0334] In addition, in this embodiment, as will be discussed in more detail below, the handle 10 of the knife assembly 800 is configured to: (i) transmit monopolar electrical power along the pull wire 230 to the knife 805; and (ii) introduce a fluid such that the fluid can be transmitted through the shaft 15 and into the tissue to clean the knife (or the area around the knife) during use, and / or to create blisters (i.e., bubbles) in the tissue.

[0335] As can be seen in Figure 81 and Figure 85 , the knife 805 includes a proximal end 810, a distal end 812, and a blade 813 extending between the proximal end 810 and the distal end 812. Preferably, the distal end 812 of the knife 805 includes a knife tip with a rounded front portion 845 and a flat rear portion 850. The proximal end 810 of the knife 805 includes a mounting portion 847 with a tapered distal portion 848. Preferably, the proximal end 810 of the knife 805 is welded to the distal end of the pull wire 230 at the mounting portion 847 such that when the pull wire 230 moves distally, the knife 805 moves distally, and when the pull wire 230 moves proximally, the knife 805 moves proximally, thereby extending and retracting the knife 805 relative to the knife housing 820. In a preferred form of the present invention, the pull wire 230 includes a braided cable.

[0336] Now observing Figure 81 , Figure 82 and Figure 85, the knife housing 820 includes a cylindrical proximal portion 835 and a conical distal portion 840. The cylindrical proximal portion 835 is configured to be received within the distal end of the shaft 15 and is connected to the distal articulation coupling assembly 70 of the distal articulation portion 25. The conical distal portion 840 extends distally from the distal end of the shaft 15. A bore 842 extends through the cylindrical proximal portion 835 and the conical distal portion 840 and opens onto the distal end 833 of the conical distal portion 840. Preferably, the knife housing 820 is formed of an electrically insulating non-conductive material (e.g., ceramic) and isolates the current delivered from the handle 10 to the knife 805.

[0337] As the pull wire 230 is transferred from the proximal end 810 of the knife 805 to the handle 10, the pull wire 230 extends through the tube 815. The tube 815 extends from the handle 10 through the shaft 15, and the distal end of the tube 815 terminates within the bore 842 of the knife housing 820, with the opening at the distal end of the tube 815 aligned with the bore 842 of the knife housing 820. As will also be discussed in more detail below, the tube 815 serves as an electrical insulator for the electrical power to travel from the handle to the knife 805 through the pull wire 230. As will also be discussed in more detail below, the tube 815 and the bore 842 also serve as a fluid path for fluid to transfer from the fluid inlet port in the handle 10, through the tube 815, through the bore 842, and outwards from the distal end 833 of the knife housing 820.

[0338] In Figures 81 - 87 , the tube 815 is shown as two separate tubes (i.e., a proximal tube 825 and a distal tube 830), with the proximal tube 825 having an inner lumen diameter larger than the inner lumen diameter of the distal tube 830. However, the tube 815 may also be formed as a single tube that tapers from the proximal end to the distal end (not shown). It should be understood that forming a tube 815 with a small diameter along the entire length of the inner lumen may create too much friction between the pull wire 230 and the wall(s) defining the tube 815, or cause fluid transferred from the fluid inlet port to the distal end of the knife housing 820 to accumulate within the inner lumen 815. Thus, whether the tube 815 is formed of two separate tubes or a single tapered tube, it is preferred that the inner lumen size is set to have a large diameter along a substantial portion of the inner lumen in order to reduce the friction between the pull wire 230 and the wall(s) defining the tube 815, and / or to allow fluid to flow easily through the tube 815 as the fluid travels from the fluid inlet port in the handle 10 and outwards from the distal end 833 of the knife housing 820. Preferably, the tube 815 is formed of polytetrafluoroethylene (PTFE).

[0339] As stated above, the pull wire 230 can be pushed distally and pulled proximally through the tube 815 to extend and retract the blade 805 relative to the blade housing 820. Significantly, the proximal end 810 of the blade 805 and the blade housing 820 are sized and shaped to: (i) prevent the blade 805 from retracting into the tube 815; and (ii) limit the distance that the blade 805 can project beyond the distal end 833 of the blade housing 820.

[0340] More particularly, as Figure 81 shown, the bore 842 of the blade housing 820 preferably includes a stepped bore, and the distal end 843 of the stepped bore 842 has a smaller diameter than the proximal end 844 of the stepped bore 842. The blade 805 moves within the stepped bore 842 to facilitate movement of the blade 805 between its fully retracted position ( Figure 83 ) and its fully extended position ( Figure 84 ). The mounting portion 847 at the proximal end 810 of the blade 805 has a larger diameter than the diameter of the tube 815, thereby preventing the blade 805 from retracting into the tube 815. Additionally, the mounting portion 847 also has a larger diameter than the diameter of the distal end 843 of the stepped bore 842, thereby preventing the mounting portion 847 of the blade 805 from extending beyond the distal end 843 of the stepped bore 842. As can be seen in Figure 85 , the tapered distal portion 848 of the mounting portion 847 has a smaller diameter than the diameter of the distal end 843 of the stepped bore 842, such that when the blade 805 moves distally within the bore 842, the tapered distal portion 848 moves distally within the distal end 843 of the stepped bore 842 until further distal movement is prevented by the mounting portion 847 contacting the shoulder that separates the distal end 843 of the stepped bore 842 from the proximal end 844 of the stepped bore 842.

[0341] Significantly, when the blade 805 is in its fully retracted position ( Figure 83 ), a portion of the blade 805 still extends beyond the distal end 833 of the blade housing 820. As will be discussed in more detail below, and as Figures 98A - 98F shown, when the blade 805 is in its fully retracted position, the distance that this portion of the blade 805 projects outward from the blade housing 820 is designed to be less than the distance between the innermost layer of the intestinal wall (i.e., the mucosal layer) and the outermost layer of the intestinal wall (i.e., the serosal layer), so as to minimize the likelihood that the blade will perforate the intestinal wall when passing through the mucosal layer.

[0342] In addition to moving the blade 805 distally and proximally within the tube 815 to facilitate extension and retraction of the blade 805 relative to the blade housing 820, the blade 805 can also be articulated relative to the handle 10. Now observing Figures 85 - 87 , in the same manner as discussed above, two hinge cables 220 extend from the handle 10 to the distal hinge coupling assembly 70 through the hinge cable housing 235 ( Figure 89) a distal seat portion 135 such that the hinge cable 220 can be pulled proximally to articulate the distal articulating portion 25 of the shaft 15 (and thereby articulate the knife housing 820 and the knife 805). However, since there are only two hinge cables (and not the four hinge cables shown in Figure 15 and Figure 16 ), the knife housing 820 (and thus the knife 805) can only articulate in a single plane, rather than the gimbal articulation provided by three or more hinge cables as discussed above.

[0343] As will be discussed in more detail below, if desired, the articulation plane can be modified by the following process: rotating the shaft 15 from the handle 10, which in turn rotates (i) the flexible proximal portion 20, (ii) the distal articulating portion 25, and (iii) the knife housing 820. Due to the way the knife housing 820 is connected to the shaft 15 (i.e., using a clamshell connector), the pull wire 230 and the knife 805 do not rotate when the shaft 15 and the knife housing 820 rotate.

[0344] Since the knife 805 is substantially uniform (i.e., symmetric), there is no need to provide independent rotational movement of the knife 805 and / or the knife housing 820 relative to the distal end of the distal articulating portion 25 of the shaft 15 (i.e., the rotation function mentioned above). Accordingly, the rotation mechanism 295 (including the HHS coil 225 and the rotation knob 395) can be removed from this version of the instrument. As will be discussed in more detail below, instead of the rotation knob 395, a fluid inlet port 855 is provided to receive fluid for irrigation.

[0345] Now observe Figures 90 - 97 , another embodiment of the handle 10 is shown. The handle 10 has been specifically designed to provide the movements necessary to actuate the knife 805. More particularly, in this form of the invention, the handle 10 includes:

[0346] (i) a slider 860 for selectively actuating the pull wire 230 (and thus selectively moving the pull wire 230 proximally and distally to facilitate retracting and extending the knife 805 relative to the knife housing 820, respectively);

[0347] (ii) a thumb lever 315 of the articulation control assembly 285 for selectively moving the hinge cable 220 (and thus selectively articulating the distal articulating portion 25 of the shaft 15 and the knife 805 away from the axis of the shaft in a single plane);

[0348] (iii) an actuation lever 365 of the push rod lock assembly 290 for selectively locking the articulation control assembly 285 in a desired position (and thus locking the thumb lever 315 and the distal articulating portion 25 of the shaft 15 in the selected position); and

[0349] (iv) The rotation knob 545 of the rotatable shaft adapter mechanism 525, which allows the shaft 15 (i.e., both the flexible proximal portion 20 and the distal articulated portion 25) and the knife housing 820 to be selectively rotated relative to the handle 10 in order to modify the plane of articulation. In this embodiment, the rotation knob 545 is selectively locked to the handle 10 by the finger latch 865.

[0350] As stated above, the handle 10 is configured to transmit monopolar electrical power along the pull wire 230 to the knife 805. To this end, and observing Figures 90 - 94 , in a preferred form of the present invention, provided is: an electrical connection port (e.g., a "banana plug") 870, which is provided at the proximal end of the grip of the handle 10 for connection to an external power supply (not shown); and a wire 875 ( Figure 91 , Figure 92 and Figure 94 ), which is provided within the internal cavity 280 of the handle 10 to direct electrical power from the electrical connection port 870 to the pull wire 230. The wire 875 is connected to the pull wire 230 using at least one crimp. The flat conductive spring 885 serves as a stopper feature and also as a conductor for applying voltage to the knife 805 through the pull wire 230, thereby creating electrical contact from the electrical connection port 870 to the knife 805 via the pull wire 230. As a result, electrical power can be transferred from an external power supply (not shown) to the electrical connection port 870, along the wire 875 to the pull wire 230, and along the pull wire 230 to the knife 805. In this way, monopolar power can be supplied to the knife 805.

[0351] As also stated above, the handle 10 is provided with a fluid inlet port 855 such that fluid can be introduced into the handle 10, transmitted through the tube 815, outwards from the distal end 833 of the knife housing 820, and into the tissue surrounding the knife 805. More particularly, and now observing Figures 95 - 97 , the proximal end of the tube 815 is bonded to the fluid inlet port 855 in the handle 10, whereby fluid can be introduced into the fluid inlet port 855 and flow distally through the tube 815 and outwards from the distal end 833 of the knife housing 820. Preferably, an insert 895 is provided to prevent fluid from flowing proximally along the path of the pull wire 230 (which extends through the handle to provide an electrical circuit path from the handle to the knife) within the handle 10. The pull wire 230 extends through the insert 895, and the insert 895 is sealed using an O-ring 900. When the insert 895 applies pressure to the O-ring 900 (i.e., deforms the O-ring 900) around the pull wire 230, a seal around the pull wire 230 is created.

[0352] At the distal end of the instrument, and as in Figure 98As shown in more detail, the mounting portion 847 of the blade 805 is formed with a recessed portion 905 intermediate the protruding portions 910 to allow fluid to flow through the tube 815 via the aperture 842 and outwards from the distal end 833 of the blade housing 820. More particularly, the recessed portion allows fluid to be passed outwards from the distal end of the blade housing 820 even when the blade 805 is in its fully extended position ( Figure 81 and Figure 84 )(i.e., when the mounting portion 847 of the blade 805 contacts the shoulder separating the proximal end 844 of the stepped aperture 842 from the distal end 843 of the stepped aperture 842). Thus, fluid can be passed outwards from the distal end of the blade housing 820 whether the blade 805 is extended or retracted from the blade housing 820.

[0353] Fluid is passed outwards from the distal end of the blade housing 820 to wash away debris that accumulates on the blade 805 or in the surrounding tissue during tissue cutting or cauterization.

[0354] Fluid can also be passed outwards from the distal end of the blade housing 820 to create blisters (i.e., bubbles) in the tissue, thereby separating the submucosa from the muscularis mucosae such that the mucosa and submucosa can be excised. More particularly, and now looking Figures 98A - 98F , to create blisters, when the blade 805 is in its retracted position ( Figure 98A ), the blade 805 is energized and inserted through the mucosa layer. Preferably, when the blade is in its retracted position ( Figure 83 ), the blade 805 is injected through the mucosa layer such that the blade does not penetrate too far into the intestinal wall and accidentally perforate the intestinal wall. After the blade 805 has been inserted through the mucosa layer ( Figure 98B ), fluid is injected beneath the mucosa layer to cause the submucosa to rise away from the underlying tissue (i.e., the muscularis mucosae)( Figure 98C ). The blade 805 is now extended ( Figure 98D ), and power is delivered to the blade 805 to cut the tissue. Significantly, the blade 805 can be moved laterally and pulled proximally against the mucosal wall such that the flat rear portion 850 retracts (i.e., stretches) the mucosa when the blade 813 cuts the mucosa ( Figure 98E and Figure 98F ). If desired, power can be delivered to the blade 805 to mark the boundary around the tissue to be excised prior to creating blisters.

[0355] The fluid injected through the blade housing 820 is typically saline. However, if desired, methylene blue dye can be added to the saline to assist the user in viewing the area that the user is cutting. Additionally, other fluids can be injected with (or in place of) the saline (e.g., a gel-like fluid that prolongs the duration of blister formation, a temperature-sensitive fluid, etc.).

[0356] In an exemplary use of the knife assembly 800 in minimally invasive surgery, the knife 805 is retracted; the shaft 15 is straightened; the handle 10 is advanced longitudinally to facilitate longitudinal advancement of the knife 805 through an entry port (e.g., through the instrument channel of an endoscope) and (e.g., along a serpentine path) into the body; the handle 10 is advanced longitudinally and / or rotated, and / or the distal articulated portion 25 of the shaft 15 is bent so that the knife 805 is adjacent to the target tissue at the internal site; the knife 805 is extended; a single electrical power is delivered to the knife 805; the knife 805 is used to perform a desired surgery (e.g., marking tissue, cutting tissue, etc.) at the internal site; the knife 805 is retracted; and the knife 805 is withdrawn from the internal site, e.g., the handle 10 is withdrawn longitudinally through the entry port (during which time, if necessary, the handle may also be rotated and / or the distal articulated portion 25 of the shaft 15 is not bent), so that the knife assembly 800 is withdrawn from the body.

[0357] If desired, a syringe (or another suitable pressurized liquid source) filled with sterile water (or another fluid) can be used to inject fluid into the fluid inlet port 855 to flush water from the distal end of the knife housing 820 to clean the knife 805 (or the target area) while the knife 805 is used to perform the desired surgery.

[0358] Additionally, if desired, fluid can be injected into the fluid inlet port 855 to flush fluid from the distal end of the knife housing 820 to create a water bubble (in the manner discussed above).

[0359] It will be appreciated that the medical device 5 with the knife assembly 800 is capable of at least the following movements:

[0360] Movement 1 - Longitudinal movement of the knife 805 achieved by sliding the slider 860 of the handle 10 (sometimes referred to herein as the "longitudinal movement function");

[0361] Movement 2 - Articulated movement of the shaft 15 and the knife 805 relative to the handle 10 achieved by articulating the thumb lever 315 of the handle 10 to articulate the distal articulated portion 25 of the shaft 15 relative to the distal end of the flexible proximal portion 20 of the shaft 15 (sometimes referred to herein as the "universal articulation function"); and

[0362] Movement 3 - Rotational movement of the shaft 15 (and thus the knife housing 820) achieved by rotational movement of the rotary knob 545 of the handle 10 (sometimes referred to herein as the "twisting movement function").

[0363] It will also be appreciated that if desired, the medical device can be modified to provide fewer (or more) than the three previously mentioned movements. For example, a rotational function can be added, additional rotational functions such as selective rotation of the shaft 15 can be added, additional articulation cables can be added, etc.

[0364] It will be further appreciated that a medical device 5 with a knife assembly 800 having Figures 81 - 98 is capable of: (i) transmitting monopolar electrical power from the handle 10 to the knife 805; and (ii) transmitting fluid from the handle 10 outwardly from the distal end of the knife housing 820.

[0365] 8. Additional construction

[0366] In the foregoing disclosure, a novel medical device 5 was described, which includes a handle, an elongate flexible shaft, and various end effectors disposed at the distal end of the shaft configured to perform medical procedures. It should be appreciated that the medical device 5 can be modified in a variety of ways to support different types of end effectors, to facilitate single-handed use of the medical device 5, to enhance the functionality of the medical device 5, etc.

[0367] Specifically, the handle 10 can be modified in a variety of ways to support different types of end effectors, to facilitate single-handed use of the medical device 5, to enhance the functionality of the medical device 5, etc. By way of example and not limitation, the distal tip of the knife 805 can be formed with a spatula configuration or another configuration (instead of Figures 81 - 85 , Figure 88 and Figure 89 the circular front configuration / flat rear configuration shown in Figure 90 and Figure 91 The slider 860 of Figure 75 and Figure 76 can be replaced with a trigger (e.g., the trigger 415 of Figure 99 and Figure 79 ). Additionally, the electrical connection for delivering monopolar electrical energy to the "hot" scissors can follow the path shown in

[0368] 9. Medical device 5 with additional degrees of articulation

[0369] As discussed above, in one form of the present invention, the novel medical device 5 generally includes a shaft 15 having: a flexible proximal portion 20; a distal articulated portion 25 configured to selectively articulate relative to the distal end of the flexible proximal portion 20; and an end effector 30 configured to selectively rotate relative to the distal end of the distal articulated portion 25. In this form of the present invention, longitudinal movement of the handle 10 can be used to selectively move the shaft 15 distally or proximally, thereby moving the end effector 30 distally or proximally; rotational movement of the handle 10 can be used to rotate the shaft 15 (and thus also the end effector 30); an articulation control assembly 285 ( Figure 25) can be used to selectively articulate the distal articulating portion 25 of the shaft 15 relative to the flexible proximal portion 20 of the shaft 15, thereby allowing control of the positioning of the end effector 30; a rotational control assembly 295( Figure 25 ) can be used to selectively rotate the end effector 30 relative to the distal articulating portion 25 of the shaft 15; and a trigger assembly 300( Figure 25 ) can be used to selectively actuate the end effector 30. It should be understood that in this form of the present invention, the flexible proximal portion 20 of the shaft 15 and the handle 10 rotate together as a unit.

[0370] As also discussed above, in another form of the present invention, the novel medical device 5 may further include a rotatable shaft adapter mechanism 525, the rotatable shaft adapter mechanism 525 being actuated by a rotary knob 545( Figures 56 - 58 ) which can be selectively rotated to facilitate allowing the shaft 15 (i.e., both the flexible proximal portion 20 and the distal articulating portion 25) to selectively rotate relative to the handle 10.

[0371] In addition, as also discussed above, the end effector 30 may include a monopolar knife assembly 800, wherein by sliding a slider 860 on the handle 10, the knife 805 can be extended and retracted relative to the knife housing 820, wherein by articulating a thumb lever 315 of the handle 10 to articulate the distal articulating portion 25 of the shaft 15 relative to the distal end of the flexible proximal portion 20 of the shaft, the shaft 15 and the knife 805 can be articulated relative to the handle 10, and wherein by rotating a rotary knob 545 of the handle 10, the shaft 15 (and thus the knife housing 820) can be rotated relative to the handle 10.

[0372] However, it should also be understood that in some cases, it may be desirable to add additional articulation to the shaft 15 of the novel medical device 5. By way of example and not limitation, when the medical device 5 is passed along a sharp bend in the colon (or other anatomical structure), the shaft 15 of the medical device 5 is constrained by the anatomy and is forced to deflect along the outer curve of the bend in the colon (or other anatomical structure), thereby making it difficult for the knife 805 to cut tissue disposed along the corresponding inner curve of the bend in the colon (or other anatomical structure). Accordingly, there is a need for a medical device that allows for greater articulation and thus more options for handling the anatomy with the knife 805.

[0373] To this end, and now observing Figure 100 and Figure 101, in another preferred form of the present invention, the novel medical device 5 further includes an intermediate articulating portion 1000 disposed between the distal end of the flexible proximal portion 20 and the proximal end of the distal articulating portion 25. As will be discussed in more detail below, the intermediate articulating portion 1000 can articulate in a single plane (e.g., in a manner similar to a human "elbow" joint) to provide additional articulation to the distal articulating portion 25 of the medical device 5. This additional articulation is sometimes referred to hereinafter as the "overall articulation function".

[0374] In the case where additional articulation is provided by the overall articulation function provided by the intermediate articulating portion 1000, the novel medical device 5 is capable of at least the following movements:

[0375] Movement 1 - The longitudinal movement of the blade 805 achieved by the longitudinal movement of the handle 10 (sometimes referred to herein as the "longitudinal movement function");

[0376] Movement 2 - The rotational movement of the blade 805 achieved by the rotational movement of the handle 10 (sometimes referred to herein as the "twisting movement function");

[0377] Movement 3 - The articulating movement of the blade 805 relative to the handle 10 achieved by articulating the distal articulating portion 25 of the shaft 15 relative to the distal end of the intermediate articulating portion 1000 of the shaft 15 (sometimes referred to herein as the "universal articulation function");

[0378] Movement 4 - The shaft 15 rotates independently of the handle 10. For example, the rotary knob 545 of the rotatable shaft adapter mechanism 525 is selectively rotated to allow the shaft 15 (and thus the flexible proximal portion 20, the intermediate articulating portion 1000, and the distal articulating portion 25) to rotate selectively relative to the handle 10;

[0379] Movement 5 - The extension and retraction of the blade 805 relative to the blade housing 820. For example, the slider 860 is selectively moved to facilitate the distal and proximal movement of the cable 230, thereby causing the blade 805 to extend and retract relative to the blade housing 820; and

[0380] Movement 6 - The articulating movement of the distal articulating portion 25 and the blade 805 relative to the flexible proximal portion 20 of the shaft 15 achieved by articulating the intermediate articulating portion 1000 of the shaft 15 relative to the distal end of the flexible proximal portion 20 of the shaft 15 (sometimes referred to herein as the "overall articulation function").

[0381] More particularly, and next observing Figures 102 - 104In this form of the invention, as will be discussed in more detail below, the novel medical device 5 includes: (i) four articulation cables 220, which are used to selectively articulate the distal articulation portion 25 relative to the distal end of the intermediate articulation portion 1000, (ii) a pull wire 230, which is used to selectively move the knife 805 between its extended position and retracted position; and (iii) an overall articulation cable 1005, which is used to selectively articulate the intermediate articulation portion 1000 relative to the distal end of the flexible proximal portion 20.

[0382] Still observing Figures 102 - 104 , the intermediate articulated portion 1000 generally includes a flexure spine 1010 (e.g., a laser cut hypotube) having a proximal end 1015, a distal end 1020, and a central cavity 1025 disposed therebetween. The proximal end 1015 of the intermediate articulated portion 1000 is mounted (e.g., welded, crimped, etc.) to the distal end 40 of the flexible outer coil 35, and the distal end 1020 of the intermediate articulated portion 1000 is mounted (e.g., welded, crimped, etc.) to the proximal articulated coupling assembly 75.

[0383] The overall articulation cable 1005 extends from the distal end 1020 of the flexion spine 1010 to the handle 10. The distal end of the overall articulation cable 1005 includes a crimp (not shown) that is welded to the distal end of the overall articulation cable 1005, which in turn is mounted to (e.g., welded to) the inner surface of the flexion spine 1010 proximal to the distal end 1020 of the flexion spine 810. As will be discussed in more detail below, the proximal end of the overall articulation cable 1005 is attached to a control assembly within the handle 10.

[0384] The portion of the overall articulation cable 1005 extending between the distal end 1020 of the flexion spine 1010 and the proximal end 1015 of the flexion spine 1010 is slidably disposed within an overall articulation cable conduit 1030 disposed within the cavity 1025 of the flexion spine 1010. The portion of the overall articulation cable 1005 extending from the distal end 40 of the flexible outer coil 35, through the flexible proximal portion 20 and through the shaft 15 to the handle 10 is slidably disposed within an articulation cable housing 235. The overall articulation cable conduit 1030 is welded to the proximal end 1015 of the flexion spine 1010, and the articulation cable housing 235 is welded to the flexible outer coil 35 of the shaft 15, but the overall articulation cable conduit 1030 is not connected to the articulation cable housing 235.

[0385] The overall hinge cable conduit 1030 and the hinge cable housing 235 separate the overall hinge cable 1005 from the hinge cable 220 / hinge cable housing 235, thereby ensuring smooth sliding movement of the overall hinge cable 1005 within the intermediate hinge portion 1000, the flexible proximal portion 20, and the shaft 15 (i.e., over the distance between the distal end 1020 of the buckling ridge 1010 and the handle 10, which can be a length of, for example, 95 cm - 140 cm, and which tends to follow a serpentine path when the medical device 5 is disposed within a patient's body).

[0386] The overall hinge cable conduit 1030 is configured to compress to a greater extent than the comparable hinge cable housing 235, so as to facilitate ensuring that the buckling ridge 1010 can be deflected to a desired angle. In a preferred form of the present invention, the overall hinge cable conduit 1030 includes a helical spring such that while allowing the overall hinge cable conduit 1030 to compress along its longitudinal dimension, proximal movement of the overall hinge cable 1005 causes the buckling ridge 1010 to articulate relative to the distal end 40 of the flexible outer coil 35.

[0387] Due to this configuration, by selectively moving the overall hinge cable 1005 proximally, the buckling ridge 1010 of the intermediate hinge portion 1000 can be selectively laterally articulated relative to the distal end 40 of the flexible outer coil 35, thereby selectively articulating the intermediate hinge portion 1000 of the shaft 15.

[0388] Significantly, since only a single overall hinge cable 1005 is provided, the intermediate hinge portion 1000 can be articulated in only a single plane. However, as will be apparent to those skilled in the art in view of the present disclosure, if desired, additional overall hinge cables 1005 can be provided in the case where articulation in additional planes is desired.

[0389] Next observe Figure 100 、 Figure 101 and Figures 105 - 108 , which illustrate a preferred mechanism for selectively moving the overall hinge cable 1005.

[0390] More particularly, as discussed above, the handle 10 generally includes: an internal cavity 280; an articulated control assembly 285 for selectively moving the articulation cable 220 (and thus selectively articulating the distal articulated portion 25 of the shaft 15); a push rod lock assembly 290 for selectively locking the articulated control assembly 285 in a desired position (and thus locking the distal articulated portion 25 of the shaft 15 in a selected position); a slider 860 for selectively actuating the pull wire 230 (and thus selectively moving the blade 805 distally and proximally relative to the blade housing 820); and a rotatable shaft adapter mechanism 525 for selectively rotating the shaft 15 (i.e., the flexible proximal portion 20, the intermediate articulated portion 1000, and the distal articulated portion 25) relative to the handle 10.

[0391] In this form of the invention, the handle 10 is also provided with an overall articulated control assembly 1035 for selectively moving the overall articulation cable 1005 proximally or distally (and thus selectively articulating the buckling ridge 1010 of the intermediate articulated portion 1000 of the shaft 15 relative to the flexible proximal portion 20 of the shaft 15).

[0392] The overall articulated control assembly 1035 generally includes: a main shaft housing 1040 fixedly mounted within the internal cavity 280 of the handle 10; a main shaft 1045 configured to selectively rotate within the main shaft housing 1040; and a knob 1050 configured to be engaged by a user.

[0393] The proximal end of the overall articulation cable 1005 exits the proximal end of the shaft 15, through a portion of the internal cavity 280 of the handle 10, and is mounted to the main shaft 1045 (e.g., via a crimp that is welded to both the overall articulation cable 1005 and the main shaft 1045, by directly welding the overall articulation cable 1005 to the main shaft 1045, etc.). The cable housing 235 for the overall articulation cable 805 preferably terminates at the proximal end of the shaft 15, however, if desired, the cable housing 235 for the overall articulation cable 1005 may extend into the internal cavity 280 of the handle 10 and terminate at the outer wall of the main shaft housing 1040.

[0394] Due to this configuration, when the knob 1050 is rotated in a first direction, the proximal end of the overall articulation cable 1005 is pulled proximally, thereby selectively articulating the buckling ridge 1010 of the intermediate articulated portion 1000 of the shaft 15 from a straight configuration into an articulated configuration (articulating relative to the flexible proximal portion 20 of the shaft 15), and when the knob 1050 is rotated in the opposite second direction, the tension on the proximal end of the overall articulation cable 1005 is relaxed and allows for distal movement, thereby causing the buckling ridge 1010 of the intermediate articulated portion 1000 of the shaft 15 to return to its non-articulated straight configuration.

[0395] It should also be understood that, if desired, the buckling ridge 1010 of the intermediate articulation portion 1000 can be configured to automatically return to its straight (i.e., non-articulated) configuration when the knob 1050 is released by the user. By way of example and not limitation, the buckling ridge 1010 can be formed of an elastically flexible material that is biased toward presenting a straight configuration. Due to this configuration, releasing the knob 1050 of the overall articulation control assembly 1035 allows the overall articulation cable 1005 to move distally (i.e., effected by the biasing force provided by the elastic properties of the buckling ridge 1010), thereby allowing the buckling ridge 1010 to return to its straight (i.e., non-articulated) configuration. Alternatively and / or additionally, if desired, an additional overall articulation cable 1005A (not shown) can be provided, wherein the distal end of the additional overall articulation cable 1005A (e.g., diametrically opposite the overall articulation cable 1005) is mounted to the inner surface of the buckling ridge 1010 proximate the distal end 1020 of the buckling ridge 1010, thereby facilitating returning the buckling ridge 1010 (and thus the intermediate articulation portion 1000) to its straight (i.e., non-articulated) configuration and / or articulating the buckling ridge 1010 in an opposite second direction.

[0396] Importantly, it is noted that rotating the knob 1050 of the overall articulation control assembly 1035 to articulate the buckling ridge 1010 of the intermediate articulation portion 1000 typically requires the use of both hands (i.e., one hand holding the handle 10 and the other hand rotating the knob 1050). However, it should be understood that, if desired, the knob 1050 can be replaced with a lever (not shown) or other actuating device to facilitate one-handed articulation of the buckling ridge 1010 of the intermediate articulation portion 1000.

[0397] In an exemplary use of the novel medical device 5 of this form in minimally invasive surgery, the blade 805 is retracted; the shaft 15 is straightened; the handle 10 is advanced longitudinally to facilitate advancing the blade 805 longitudinally through the entry port and (e.g., along a serpentine path) into the advancing body; the handle 10 is advanced longitudinally and / or rotated, and / or the distal articulation portion 25 of the shaft 15 is articulated, and / or the intermediate articulation portion 1000 is articulated such that the blade 805 is adjacent to the target tissue on the inner side of the body; the blade 805 is extended; a single electrical power is delivered to the blade 805; the blade 805 is used to perform the desired surgery (e.g., marking tissue, cutting tissue, etc.); the blade 805 is retracted; and the medical device 5 is withdrawn from the body, e.g., the handle 10 is withdrawn longitudinally through the entry port (during which time the handle can also be rotated, and / or the distal articulation portion 25 of the shaft 15 is straightened (i.e., moved to present its non-articulated configuration), and / or the buckling ridge 1010 of the intermediate articulation portion 1000 is straightened (i.e., moved to present its non-articulated configuration).

[0398] If desired, a syringe (or another suitable pressurized fluid source) filled with sterile water (or another fluid) can be used to inject fluid into fluid inlet port 855 to flush water from the distal end of knife housing 820 to clean knife 805 (or surrounding tissue) while knife 805 is used to perform the desired surgery.

[0399] It will be appreciated by those skilled in the art that, if desired, the medical device can be modified to provide less (or more) movement than that mentioned previously. For example, a rotational function can be added, an additional rotational function (such as selective rotation of shaft 15) can be added, etc.

[0400] Modifications to the preferred embodiment

[0401] It should be understood that many additional variations of the details, materials, steps, and component arrangements that have been described and illustrated herein to explain the nature of the invention can be made by those skilled in the art while still remaining within the principles and scope of the invention.

Claims

1. A device for performing minimally invasive surgery, the device comprising: a shaft having a distal end and a proximal end; a monopolar knife assembly attached to the distal end of the shaft, the monopolar knife assembly including a knife and a knife housing; a handle attached to the proximal end of the shaft; wherein the shaft includes a flexible portion and a hinged portion, wherein the flexible portion extends distally from the handle, and the hinged portion extends distally from the flexible portion; wherein the knife housing includes a cylindrical proximal portion and a conical distal portion, the cylindrical proximal portion being connected to the hinged portion of the shaft, the conical distal portion extending distally from the cylindrical proximal portion; wherein at least one hinge cable extends from the handle to the hinged portion such that when tension is applied to the at least one hinge cable, the hinged portion deflects; wherein an actuating element extends through the shaft from the handle to the knife, the actuating element being a pull wire such that when the pull wire moves distally, the knife moves distally, and when the pull wire moves proximally, the knife moves proximally, thereby causing the knife to extend and retract relative to the knife housing; and wherein the actuating element transmits electrical power from the handle to the knife.

2. The device according to claim 1, wherein, the knife includes a distal end and a proximal end, and further wherein the distal end of the knife includes a circular front portion and a flat rear portion.

3. The device according to claim 1, wherein, the knife includes a distal end and a proximal end, and further wherein the proximal end of the knife includes a mounting portion.

4. The device according to claim 3, wherein, the mounting portion includes a distal end, a proximal end, and a cylindrical wall extending between the distal end and the proximal end, and further wherein the cylindrical wall is recessed to provide a plurality of recessed portions and a plurality of protruding portions.

5. The device according to claim 1, wherein, the knife housing includes a stepped hole having a first portion and a second portion, wherein the first portion is distal to the second portion, and further wherein the first portion has a smaller diameter than the second portion.

6. The device according to claim 5, wherein, the second portion limits the extension of the knife relative to the knife housing.

7. The device according to claim 1, wherein, the device further includes a tube extending from the handle to the distal end of the shaft.

8. The device according to claim 7, wherein, the actuating element extends through the tube.

9. The device according to claim 7, wherein, the tube is configured such that fluid can pass through the tube from the handle to the distal end of the shaft.

10. The device according to claim 9, wherein, the handle includes a fluid inlet port for receiving fluid.

11. The device according to claim 1, wherein, the shaft includes a second hinged portion, wherein the second hinged portion is disposed between the flexible portion and the hinged portion.

12. The device according to claim 11, wherein, At least one articulated cable extends from the handle to the second articulated portion such that when tension is applied to the at least one articulated cable, the second articulated portion deflects.

13. The apparatus according to claim 11, wherein, the articulated portion and the second articulated portion are articulated independently of each other.

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