WO2023172986A2

WO2023172986A2 - Articulable surgical apparatus

Info

Publication number: WO2023172986A2
Application number: PCT/US2023/063991
Authority: WO
Inventors: Mark Richey
Original assignee: Freshwater Bay Industries, Llc
Priority date: 2022-03-08
Filing date: 2023-03-08
Publication date: 2023-09-14
Also published as: WO2023172986A3

Abstract

An articulable surgical instrument includes a first handle portion, a second therapy delivery portion, and a knuckle collar articulably coupling the first handle portion to the second therapy delivery portion across a lockable ball joint.

Description

ARTICULABLE SURGICAL APPARATUS

BACKGROUND

Technical Field

[0001] The present disclosure generally relates to a medical device. More particularly, but not exclusively, the present disclosure relates to surgical apparatus having a first handle portion and a second therapy delivery portion arranged for at least partial insertion into a patient’s body.

Description of the Related Art

[0002] Surgical instruments are known. The present inventor has introduced many such devices to the world including a Vaginal Surgical Apparatus disclosed in U.S. non-provisional patent application 16/690,100, filed November 20, 2019; a Vaginal Surgical Apparatus disclosed in U.S. non- provisional patent application 16/427,206 filed May 30, 2019, which is now issued as U.S. Patent No. 11 ,154,327; a Vaginal Surgical Apparatus disclosed in U.S. non-provisional patent application 16/030,701 , filed on July 9, 2018, which is now issued as U.S. Patent No. 10,327,813; a Vaginal Surgical Apparatus disclosed in International Application PCT/US16/37014 filed on June 10, 2016; a Vaginal Surgical Apparatus disclosed in U.S. non-provisional patent application 15/691 ,194 filed August 30, 2017, now U.S. Patent No. 10,052,131 ; a Vaginal Surgical Apparatus disclosed in U.S. non-provisional patent application 15/480,227 filed on April 5, 2017, which is now issued as U.S. Patent No. 10,052,130; a Vaginal Surgical Apparatus disclosed in U.S. non- provisional patent application 15/208,867 filed July 13, 2016, now U.S. Patent No. 9,655,646; a Vaginal Surgical Apparatus disclosed in U.S. non-provisional patent application 15/179,215 filed June 10, 2016, and now abandoned; an Apparatus For Repositioning The Vagina, Cervix, Uterus And Pelvic Floor And Method For Securing Same disclosed in U.S. provisional patent application 62/174,127 filed June 11 , 2015, and now expired; an Apparatus For Repositioning The Vagina, Cervix, Uterus And Pelvic Floor And Method For Securing Same disclosed in U.S. provisional patent application 62/193,721 filed July 17, 2015, and now expired; an Apparatus For Repositioning The Vagina, Cervix, Uterus And Pelvic Floor And Method For Securing Same disclosed in U.S. provisional patent application 62/252,810 filed November 9, 2015, and now expired; an Apparatus For Repositioning The Vagina, Cervix, Uterus And Pelvic Floor And Method For Securing Same disclosed in U.S. provisional patent application 62/257,090 filed November 18, 2015, and now expired; an Apparatus For Repositioning The Vagina, Cervix, Uterus And Pelvic Floor And Method For Securing Same disclosed in U.S. provisional patent application 62/265,038 filed December 9, 2015, and now expired; an Apparatus For Repositioning The Vagina, Cervix, Uterus And Pelvic Floor And Method For Securing Same disclosed in U.S. provisional patent application 62/312,069 filed March 23, 2016, and now expired; an Apparatus For Repositioning The Vagina, Cervix, Uterus And Pelvic Floor And Method For Securing Same disclosed in U.S. non-provisional patent application 13/852,784 filed May 31 , 2013, and now issued as U.S. Patent No. 10,166,044; and an Apparatus For Repositioning The Vagina, Cervix, Uterus And Pelvic Floor And Method For Securing Same disclosed in U.S. nonprovisional patent application 14/971 ,512 filed December 16, 2015, and now abandoned.

[0003] The disclosures of all references mentioned above and throughout the specification, as well as the disclosures of all references mentioned in those references, are hereby incorporated herein by reference. [0004] All of the subject matter discussed in the Background section is not necessarily prior art and should not be assumed to be prior art merely as a result of its discussion in the Background section. Along these lines, any recognition of problems in the prior art discussed in the Background section or associated with such subject matter should not be treated as prior art unless expressly stated to be prior art. Instead, the discussion of any subject matter in the Background section should be treated as part of the inventor’s approach to the particular problem, which, in and of itself, may also be inventive. BRIEF SUMMARY

[0005] The following is a summary of the present disclosure to provide an introductory understanding of some features and context. This summary is not intended to identify key or critical elements of the present disclosure or to delineate the scope of the disclosure. This summary presents certain concepts of the present disclosure in a simplified form as a prelude to the more detailed description that is later presented.

[0006] The device, method, and system embodiments described in this disclosure (/.e., the teachings of this disclosure) enable medical practitioners to perform improved surgical procedures using an articulable surgical instrument. [0007] In a first embodiment, an articulable surgical instrument, includes: a first handle portion, a second therapy delivery portion, and a knuckle collar articulably coupling the first handle portion to the second therapy delivery portion across a lockable ball joint.

[0008] In some cases of the first embodiment, the first handle portion includes a surgical table anchor. In these or other cases, the second therapy delivery portion is formed from a metal such as aluminum. In still other cases, at least one of the first handle portion and the second therapy delivery portion is formed from an alloy that includes at least one of aluminum, steel, platinum, chromium, and copper. Also in some cases of the first embodiment, at least one of the first handle portion and the second therapy delivery portion is formed from a light transmissive material.

[0009] Sometimes in the first embodiment, at least one of the first handle portion and the second therapy delivery portion is arranged for at least one of a pelvic surgical procedure, a vaginal surgical procedure, an anal surgical procedure, a gastric surgical procedure, a cranial surgical procedure, and an orthopedic surgical procedure. In these and other cases, the second therapy delivery portion includes at least one channel arranged to pass at least one medical device. In some cases, the lockable ball joint includes a first ball portion arranged to cooperate with one end of one of the first handle portion and the second therapy delivery portion, and wherein the lockable ball joint further includes a second ball portion arranged to cooperate with another end of the other of the first handle portion and the second therapy delivery portion.

And in some cases, the lockable ball joint includes an unattached spherical or semi-spherical structure positionable between the first handle portion and the second therapy delivery portion, said spherical or semi-spherical structure being held in place by the knuckle collar.

[0010] In a second embodiment, a method of forming an articulable surgical instrument, includes: providing a first handle portion having an elongated handle body with a proximal end and a distal end, providing a second therapy delivery portion having an elongated therapy delivery body, [0011 ] arranging a knuckle collar over a cooperating ball portion of a lockable ball joint, affixing a stem of the cooperating ball portion to one of the distal end of the elongated handle body and the proximal end of the elongated therapy delivery body, and removably coupling the knuckle collar to the other one of the distal end of the elongated handle body and the proximal end of the elongated therapy delivery body.

[0012] In some cases of the second embodiment, at least one of the first handle portion and the second therapy deliver portion is formed of a plastic, and in some cases, at least one of the first handle portion and the second therapy deliver portion is arranged for sterilization. Sometime in the second embodiment, at least one of the first handle portion and the second therapy deliver portion is disposable, and sometimes at least one of the first handle portion and the second therapy deliver portion are formed from a same material.

[0013] In a third embodiment, a lockable ball joint for a surgical instrument, includes: a stem arranged for attachment to a distal end of a first medical device portion, a ball-like portion affixed to the stem, the ball-like portion having a lower spherical portion at which the stem is affixed and an upper spherical portion arranged to cooperate with a proximal end of a second medical device portion, and a generally cylindrical knuckle collar having a proximal end and a distal end, the proximal end of the generally cylindrical knuckle collar having an inside diameter X, and the distal end of the generally cylindrical knuckle collar having an inside diameter Y, wherein X is less than Y, wherein X is less than a diameter of the ball-like portion, wherein X is greater than a cross-sectional dimension of the stem, and wherein Y is greater than a diameter of the ball-like portion, wherein a thread structure is formed inside the generally cylindrical knuckle collar, the thread pattern arranged to receive a cooperative thread structure integrated in the proximal end of the second medical device portion, wherein the proximal end of the generally cylindrical knuckle collar has a first inside taper arranged to cooperate with the lower spherical portion of the ball-like portion, wherein the proximal end of the generally cylindrical knuckle collar has a second outside taper arranged to cooperate with a mating surface of the distal end of a first medical device portion, and wherein the distal end of the generally cylindrical knuckle collar is arranged to receive the proximal end of the second medical device portion in such a manner that prior to tightening the generally cylindrical knuckle collar, the first and second medical device portions are permitted to rotate with respect to each other and further permitted to articulate with respect to each other, and that after tightening the generally cylindrical knuckle collar, the first and second medical device portions are temporarily fixed in a selected relationship to each other.

[0014] Sometimes in the third embodiment, the generally cylindrical knuckle collar is hand tightened. Sometimes, the second medical device portion is arranged with a semispherical hollow arranged to cooperate with the upper spherical portion of the ball-like portion after the generally cylindrical knuckle collar is tightened. And sometimes, the generally cylindrical knuckle collar is formed from a metal or an alloy that includes at least one of aluminum, platinum, gold, chromium, copper, and steel. In these or other cases of the third embodiment, the generally cylindrical knuckle collar is formed from a composite material.

[0015] This Brief Summary has been provided to describe certain concepts in a simplified form that are further described in more detail in the Detailed Description. The Brief Summary does not limit the scope of the claimed subject matter, but rather the words of the claims themselves determine the scope of the claimed subject matter.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0016] Non-limiting and non-exhaustive embodiments are described with reference to the following drawings, wherein like labels refer to like parts throughout the various views unless otherwise specified. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements are selected, enlarged, and positioned to improve drawing legibility. The particular shapes of the elements as drawn have been selected for ease of recognition in the drawings. One or more embodiments are described hereinafter with reference to the accompanying drawings in which:

[0017] FIG. 1 is a first embodiment of an articulable surgical instrument;

[0018] FIG. 2A is an exploded view of the articulable surgical instrument of FIG. 1 ;

[0019] FIG. 2B is an exploded view of a second embodiment of an articulable surgical instrument;

[0020] FIG. 3 is an articulable surgical instrument embodiment articulated through a range of motion;

[0021] FIG. 4A is six elevation views of a first handle portion of an articulable surgical instrument;

[0022] FIG. 4B is four axonometric views of a first handle portion of an articulable surgical instrument;

[0023] FIG. 5A is six elevation views of a knuckle collar of an articulable surgical instrument;

[0024] FIG. 5B is four axonometric views of a knuckle collar of an articulable surgical instrument;

[0025] FIG. 6A is six elevation views of a second therapy delivery portion of an articulable surgical instrument; [0026] FIG. 6B is four axonometric views of a second therapy delivery portion of an articulable surgical instrument;

[0027] FIG. 7A is six elevation views of an adjustable disc of an articulable surgical instrument and six elevation views of a locking structure of the articulable surgical instrument;

[0028] FIG. 7B is four axonometric views of the adjustable disc of an articulable surgical instrument and four axonometric views of the locking structure of the articulable surgical instrument;

[0029] FIG. 8A is six elevation views of a ball structure of an articulable surgical instrument and six elevation views of an optional lower seat structure of the articulable surgical instrument;

[0030] FIG. 8B is four axonometric views of the ball structure of an articulable surgical instrument and four axonometric views of the optional lower seat structure of the articulable surgical instrument;

[0031] FIG. 9A is a first perspective view of an articulable surgical instrument embodiment in use with a surgical tool; and [0032] FIG. 9B is a second perspective view of the articulable surgical instrument of FIG. 9A in use with the surgical tool.

[0033] In the present disclosure, for brevity, certain sets of related figures may be referred to as a single, multi-part figure to facilitate a clearer understanding of the illustrated subject matter. For example, FIGS. 2A-2B may be individually or collectively referred to as FIG. 2. FIGS. 4A-4B may be individually or collectively referred to as FIG. 4. FIGS. 5A-5B may be individually or collectively referred to as FIG. 5. FIGS. 6A-6D may be individually or collectively referred to as FIG. 6. FIGS. 7A-7B may be individually or collectively referred to as FIG. 7. FIGS. 8A-8B may be individually or collectively referred to as FIG. 8. And FIGS. 9A-9B may be individually or collectively referred to as FIG. 9. Structures earlier identified are not repeated for brevity. DETAILED DESCRIPTION

[0034] The present disclosure may be understood more readily by reference to this detailed description and the accompanying figures. The terminology used herein is for the purpose of describing specific embodiments only and is not limiting to the claims unless a court or accepted body of competent jurisdiction determines that such terminology is limiting. Unless specifically defined in the present disclosure, the terminology used herein is to be given its traditional meaning as known in the relevant art.

[0035] In the following description, certain specific details are set forth in order to provide a thorough understanding of various disclosed embodiments. However, one skilled in the relevant art will recognize that embodiments may be practiced without one or more of these specific details, or with other methods, components, materials, etc. Also in these instances, well-known structures may be omitted or shown and described in reduced detail to avoid unnecessarily obscuring more detailed descriptions of the embodiments.

[0036] In many medical procedures, a medical practitioner accesses an internal cavity of a patient using a surgical instrument. In some cases, the medical practitioner accesses the internal cavity for diagnostic purposes. In other cases, the practitioner accesses the cavity to provide treatment. In still other cases different therapy is provided. The device, method, and system embodiments described in this disclosure (/.e., the teachings of this disclosure) enable a medical practitioner to perform certain surgical procedures on the body of a patient with heretofore unknown improvements. One or more of these certain surgical procedures may, for example, be performed more quickly, more efficiently, more safely, less expensively, with fewer medical personnel in the surgical theater, with better visibility, and with still other benefits. The surgery may be pelvic surgery, vaginal surgery, anal surgery, abdominal surgery, oral or throat surgery, ear surgery, nasal surgery, or some other type of surgery as will be recognized by those of skill in the art. The patient may be a human patient or a non-human patient. [0037] Prior to setting forth the embodiments however, it may be helpful to an understanding thereof to first set forth definitions of certain terms that are used hereinafter.

[0038] “Articulable surgical instrument” means a surgical instrument having at least one first handle portion 102, at least one knuckle collar 104, and at least one second therapy delivery portion 106 wherein the knuckle collar 104 is arranged to facilitate a lockable ball joint between the first and second portions. Various embodiments of articulable surgical instruments 100, including certain required structures and various other optional structures, are illustrated and described in the present disclosure. For the avoidance of doubt, an articulable surgical instrument 100 embodiment taught in the present disclosure is limited only by the claims appended hereto.

[0039] “Medical practitioner” means any human being that directly or indirectly performs, assists, or works to enable the performance of a medical procedure using an articulable surgical instrument of the type described herein. In the present disclosure, for simplicity, a medical practitioner may in some cases be described in the context of the male gender. It is understood that a medical practitioner can be of any gender, and the terms “he,” “his,” and the like as used herein, are to be interpreted broadly inclusive of all known gender definitions.

[0040] “Patient” means a biological entity having a body that is, or will be, subject to an invasive medical procedure using an articulated surgical instrument of the type disclosed and contemplated herein. The patient may be a human being or some other biological entity such as a mammal, a reptile, or some other animal. Where the patient is a human being, the human being may be further characterized by specific characteristics of a human being such as male, female, babies, infants, adolescents, men, women, people in specific age brackets such as under 18, older than 18, older than 20, older than 25, older than 30, older than 35, older than 40, older than 45, older than 50, older than 55, older than 60, older than 65, older than 70, older than 75, older than 80, older than 85, older than 90, older than 95, and older than 100. The patient may be characterized in terms of health. The patient may be characterized in terms of fitness. The patient may be characterized in terms of typical activities that he or she may perform. In the present disclosure, for simplicity, a patient may in some cases be described in the context of a human being of the male gender. It is understood that a patient can be any animal (/.e., biological entity) of any gender, and the terms “he,” “his,” and the like as used herein, are to be interpreted broadly inclusive of all known gender definitions.

[0041] “Suitable medical material,” as used herein, means a biocompatible material that is generally tolerated, at least temporarily, by the body or anatomical body parts of a human patient. A non-limiting, non- exhaustive list of suitable medical materials includes metals, which may be pure metal or an alloy, and which may be cast or machined, and which may be aluminum, steel, platinum, chromium, copper, or some other metal or metals. The non-limiting, non-exhaustive list of suitable medical materials further includes rubber or some other elastomer, silicone, plastic, glass, a polymer, and composite materials, which may be light transmissive materials, transparent materials, semi-transparent materials, or opaque materials, and which may include polymethyl methacrylate such as LUCITE, polyoxymethylene (POM) such as DELRIN, and polycarbonate such as SUSTANAT. The non-limiting, non-exhaustive list of suitable medical materials may further still include any suitable combination of the materials expressly listed herein and/or other synthetic, natural, and composite materials not expressly listed though as would be known by those of skill in the medical device manufacturing arts.

[0042] Suitable materials that are capable of withstanding medical device sterilization procedures include metals, such as stainless steel and aluminum, and polymers, such as polyoxymethylene (POM) commonly known under the DuPont™ brand name Delrin®

[0043] “Surgical instrument” and “surgical tool,” which may be used interchangeably, refer to a device, instrument, apparatus, constructed element or composition, machine, implement, or similar or related article that can be utilized to diagnose, prevent, treat or manage a disease or other medical condition(s). The surgical instruments described herein may, depending on the instrument and the embodiment, partially or fully penetrate the body of a patient, be permanently or temporarily implanted within a patient, or utilized to deliver a therapy (e.g., medicine, nutrients, other medical tools or devices, one or more other therapeutic devices, and the like) to a patient. In many embodiments the surgical instruments provided herein are sterile, and subject to regulatory requirements relating to their sale and use. Representative examples of surgical instruments contemplated herein include, for example, vaginal surgical apparatuses; apparatuses for repositioning the vagina, cervix, uterus and pelvic floor and for securing the same; cardiovascular devices for implanting or otherwise placing therapy such as implantable cardioverter defibrillators, pacemakers, stents, stent grafts, bypass grafts, catheters and heart valves; tools to perform or assist in the implantation of orthopedic implants such as hip and knee prosthesis; tools to perform or assist in the implantation of spinal implants and hardware (spinal cages, screws, plates, pins, rods and artificial discs); tools to perform or assist in the implantation of a wide variety of medical tubes, cosmetic and I or aesthetic implants (e.g., breast implants, fillers); tools to perform or assist in the delivery of a wide variety of polymers, bone cements, bone fillers, scaffolds, and naturally occurring materials (e.g., heart valves, and grafts from other naturally occurring sources); tools to perform or assist in the placement of intrauterine devices; tools to perform or assist in the implantation of orthopedic hardware (e.g., casts, braces, tensor bandages, external fixation devices, tensors, slings and supports) and internal hardware (e.g., K-wires, pins, screws, plates, and tools to perform or assist in the implantation or other medical use of intramedullary devices (e.g., rods and nails)); tools to perform or assist in the implantation of cochlear implants; tools to perform or assist in the implantation of dental implants; tools to perform or assist in the delivery of medical polymers, tools to perform or assist in the implantation of a wide variety of neurological devices; and tools to perform or assist in the implantation of artificial intraocular eye lenses. [0044] The terms “surgical suite,” “surgical theater,” “operating room,” and the like may be used interchangeably in the present disclosure. A surgical suite means an area that includes one or more rooms or designated areas where surgical procedures may be performed. Unless the context expressly or clearly distinguishes otherwise beyond any reasonable doubt, a surgical suite may include zero or more triage areas, recovery rooms, emergency rooms, offices, curtained-off areas, and the like.

[0045] In the present disclosure, a first embodiment of a novel and non- obvious articulable surgical instrument 100A is represented in FIG. 1 and other figures, and a second embodiment of a novel and non-obvious articulable surgical instrument 100B is represented in FIG. 2B and other figures. In some cases, the first and second articulable surgical instrument 100A, 100B embodiments are formed with one, several, or even all identical or at least substantially similar sub-structures. To this end, the surgical devices of the present disclosure may in some cases be interchangeably referred to as articulable surgical instrument 100A (FIGS. 1 , 2A), articulable surgical instrument 100B (FIG. 2B), and articulable surgical instrument 100 (e.g., FIGS.

3, 9A, 9B), and those of skill in the art will recognize that any suitable number of the structures illustrated, described, or illustrated and described herein may be combined without departing from the inventive concepts of the present disclosure.

[0046] FIG. 1 is a first embodiment of an articulable surgical instrument 100A having a first handle portion 102, a second therapy delivery portion 106, and a knuckle collar 104 articulably coupling the first handle portion 102 to the second therapy delivery portion 106 across a lockable ball joint. The first handle portion 102 has a proximal end 102p and a distal end 102d. The knuckle collar 104 has a proximal end 104p and a distal end 104d. And the second therapy delivery portion 106 has a proximal end 106p and a distal end 106d. In at least some cases, the handle portion 102 of the articulable surgical instrument 100A has a first handle attachment structure 102a, which may be arranged in any suitable manner to permanently or removably affix the articulable surgical instrument 100A to a surgical table, a cart, or some other stable structure in the surgical theatre.

[0047] The second therapy delivery portion 106 of the articulable surgical instrument 100A may optionally include one or more adjustable discs 108. In some cases, the position of an adjustable disc 108 is maintained by one or more locking structures 110. In at least some cases, one or more of the optional adjustable discs 108 and one or more optional locking structures 110 include a non-contiguous section (e.g., an opening, a pass-through, a break, or the like). The non-contiguous section may be aligned proximate to a tool channel 112, which itself is used to deliver therapy to a patient.

[0048] In some cases, a portion of the outer surface of one or both of the first handle portion 102 and the second therapy delivery portion 106 may include a thread structure. The thread structure may be used cooperatively with an adjustable disc 108, a locking structure 110, or some other structure. In the embodiment of FIG. 1 , for example, the threaded structure on the outer surface of the second therapy delivery portion 106 is arranged to cooperatively receive the optional adjustable discs 108 and one or more optional locking structures 110, both of which in this case have an internal thread portion arranged to mate with the thread structure of the second therapy delivery portion 106.

[0049] The articulable surgical instrument 100A of FIG. 1 includes a therapy port 114. While the therapy port 114 may be formed in any suitable way and with any suitable sub-structure, the therapy port 114 of FIG. 1 is arranged as an aperture in the distal end 106d of the second therapy delivery portion 106. In this case, the tool channel 112 terminates at the therapy port 114.

[0050] In at least one exemplary use, the articulable surgical instrument 100A is deployed partially into the body of a patient during a surgical procedure. The tool channel 112 of the second therapy delivery portion 106 receives a tenaculum. The distal end of the tenaculum (e.g., a set of clampable, sharp hooks) advances through the tool channel 112 into an internal cavity in the body of a patient, wherein tissue of interest is accessible via the therapy port 114.

[0051 ] A shaped bolus 116 is included at the distal end 106d of the second therapy delivery portion 106. The shaped bolus 116 may have a larger diameter or cross section than the main body of the second therapy delivery portion 106 in some cases, but in other cases, the shaped bolus 116 may have a smaller diameter or cross section. The shaped bolus 116 may be used to expand tissue, biological material, or other materials inside the body of the patient. Alternatively, the shaped bolus 116 may be formed narrowly to permit easier entry of the second therapy delivery portion 106 into the body of the patient. In still other cases, the shaped bolus 116 may be rounded, squared, or formed with some other selected shape to functionally assist in the performance of a surgical procedure.

[0052] In at least one case, the shaped bolus may include two or more sub-structures (not shown in FIG. 1 ) that are movably arranged, with respect to each other, to change the shape, size, orientation, or the like of the distal end 106d of the second therapy delivery portion 106. For example, the shaped bolus 116 in some cases may include a one or more movable portions and optionally, one or more fixed portions, that permit the distal end 106d to expand after the second therapy delivery portion 106 is advanced into the body of the patient.

[0053] FIG. 2A is an exploded view of the articulable surgical instrument 100A of FIG. 1 . Some reference numbers from FIG. 1 are omitted from FIG. 2A to avoid unnecessarily cluttering the figure, however, it is evident the structures remain present. The optional adjustable disc 108 and the optional locking structure 110 are removed from the body of the second therapy delivery portion 106 to better illustrate that these structures may be movable and lockable along the entire length of the thread structure on the outer surface of the second therapy delivery portion 106.

[0054] A ball structure 118 is visible in the exploded view of FIG. 2A, which was obscured in the assembled articulable surgical instrument 100A of FIG. 1 . The ball structure 118 is arranged in such a manner that the second therapy delivery portion 106 and the first handle portion 102 are permitted to articulate relative to each other. At some point in time, the knuckle collar 104 is tightened, and the by such tightening, the first handle portion 102 and the second therapy delivery portion 106 are temporarily locked in their positions relative to each other.

[0055] The articulable surgical instrument 100A of FIGS. 1 and 2A may optionally include a lower seat structure 120. The lower seat structure 120 may encircle a stem 118s (FIG. 8) of the ball structure 118. The lower seat structure 120, when included, may form all or part of the distal end 102d of the first handle portion 102. An internal tapered portion (/.e., internal cradle 120c in FIG. 4) of the lower seat structure 120 is arranged to cradle or otherwise mate with a cooperative external taper 104e (FIG. 5) of the proximal end 104p of the knuckle collar 104. Such cooperative shapes facilitate free motion of the knuckle collar 104 relative to the first handle portion 102 (FIG. 3). In some embodiments, when the knuckle collar 104 is tightened, substantial surface areas of the mated taper portions of the lower seat structure 120 and the knuckle collar 104 may be in direct contact with each other, which facilitates locking of the first handle portion 102 to the second therapy delivery portion 106. In other embodiments, the cooperative shapes of the mated taper portions of the lower seat structure 120 and the knuckle collar 104 facilitate movement of the structures relative to each other, but there is no direct contact.

[0056] When the optional lower seat structure 120 is included, the articulable surgical instrument 100A embodiment may be referred to as a second embodiment of an articulable surgical instrument 100B (FIG. 2B). Accordingly, the principles of the articulable surgical instruments presented in this disclosure may individually or collectively applied to any embodiment, and each of the articulable surgical instrument 100A, 100B embodiments may also be referred to as simply an articulable surgical instrument 100.

[0057] FIG. 2B is an exploded view of a second embodiment of an articulable surgical instrument 100B. As evident in FIG. 2B, the ball structure 118 passes through the lower seat structure 120 and is fixedly or removably attached to the first handle portion 102. In this embodiment, the lower seat structure 120 is arranged as the distal end 102d of first handle portion 102 or a portion thereof.

[0058] FIG. 3 is an articulable surgical instrument 100 embodiment articulated through a range of motion. The first handle portion 104, knuckle collar 104, and second therapy delivery portion 106 are delineated; other structures, though present, are not identified to avoid unnecessarily cluttering the illustration.

[0059] A legend 122 in FIG. 3 represents the range of motion of at least one embodiment of an articulable surgical instrument 100. As indicated, the first handle portion 102 has a first handle portion axis 130h and the second therapy delivery portion 106 has a second therapy delivery portion axis 130t. In some cases, and at some times, the first handle portion 102 and the second therapy delivery portion 106 share a common axis, and in other cases, the two portions share a common point of connection while each portion is aligned along a different axis.

[0060] As evident in the legend 122, the second therapy delivery portion 106, relative to the first handle portion 102, may be moved and temporarily locked at any position from a common axis through a full range of motion 132f. The full range of motion 132f may be measured as a sum of a first range of motion “north” of the common axis 132n and a second range of motion “south” of the common axis 132s. In at least some cases, the full range of motion 132f (/.e., 132n plus 132s) may be ninety degrees (90°), In other cases, the full range of motion 132f may be some less or more than ninety degrees (90°).

[0061] In a Cartesian coordinate system, if: 1) the articulable surgical instrument 100 is oriented at an initial position such that the first handle portion 102 and second therapy delivery portion 106 are commonly aligned along the Z-axis, and if: 2) the first handle portion maintains its alignment along the Z- axis, then the second therapy delivery portion 106 may be moved and locked anywhere in the X-Y plane up to N degrees (N°); wherein in some embodiments, N° is ten degrees (10°); in some embodiments, N° is thirty degrees (30°); in some embodiments, N° is forty-five degrees (45°); in some embodiments, N° is sixty degrees (60°); and in still other embodiments, N° is some other deflection from the Z-axis.

[0062] Considering again the articulable surgical instrument 100 in a Cartesian coordinate system, in some cases, the range of motion north 132n may be considered as motion along the positive and negative X-axis and the positive Y-axis; and in these cases, the range of motion south 132S may be considered as motion along the positive and negative X-axis and the negative Y-axis. Other orientations are of course contemplated. In some embodiments, the full range of motion north 132n is equivalent to the full range of motion south 132s (e.g., 132n and 132s both equal forty-five degrees (45°), 132n and 132s both equal thirty degrees (30°), or 132n and 132s both equal some other maximum deflection from the Z-axis). In other embodiments, the full range of motion north 132n may be different from the full range of motion south 132s (e.g., 132n equals forty-five degrees (45°) and 132s equal ten degrees (10°)). [0063] As further evident in the legend 122 of FIG. 3, the first handle portion 102 and the second therapy delivery portion 106 may rotate relative to each other. In some cases, the full range of rotational motion 132r is a full and free range of rotational motion of 360°; in other cases, the full range of rotational motion is less than 360°.

[0064] Turning back to FIGS. 1 and 2A, it will be understood by those of skill in the art that when the proximal end 104p of the knuckle collar 104 encircles the stem of the ball structure 118, and when the distal end 104d of the knuckle collar 104 is loosely threaded on the proximal end 106p of the second therapy delivery portion 106, then the second therapy delivery portion 106 may freely rotate 360° around the second therapy delivery portion axis 130t. In other embodiments, however, a boss, a protrusion, a pin, or some other structure may cooperatively mate with an end of a channel or a groove, another boss, protrusion, or pin, or some other structure or structures to limit how the range of rotational motion 132r of the first handle portion 102 relative to the second therapy delivery portion 106. Such limitation may be in cases where one or both of the first handle portion 102 and the second therapy delivery portion 106 have embedded wires, embedded electronic sensors. Such limitation may also be for other reasons such as patient comfort, patient safety, or still other reasons.

[0065] FIG. 4A is six elevation views of a first handle portion 102 of an articulable surgical instrument 100. FIG. 4B is four axonometric views of the first handle portion 102 of the articulable surgical instrument 100.

[0066] The first handle portion 102 is formed partially or entirely from suitable medical materials in any desired composition. The first handle portion 102 may be sterilizable (e.g., cleaned to a medically acceptable state via any known sterilization apparatus and technique such as, but not limited to, an autoclave, a steam autoclave, a dry heat oven, and liquid or gaseous chemical bath, and ultraviolet light). Additionally, or in the alternative, the first handle portion 102 may be disposable.

[0067] In at least some cases, the first handle portion 102 has at least one textured surface. The texture may be a knurled surface, a ribbed surface, an abraded surface, or some other texture that facilitates friction when the articulable surgical instrument 100 is manually manipulated.

[0068] The first handle portion 102 may include a surgical table anchor 102a. In at least some cases, the surgical table anchor 102a has an orientation sub-structure 124. The surgical table anchor 102a may be sized, shaped, or otherwise configured to be locked into a proprietary or standardized fixture of a surgical table, a cart, or some other stable structure in the surgical theatre. In this way, the articulable surgical instrument 100 may be permanently or temporarily affixed in a stable, secure environment for patient safety, patient comfort, free range of motion of the medical practitioner, or for some other reason. In at least one case, such as during a pelvic procedure, the articulable surgical instrument 100 is affixed to the surgical table using the first handle attachment structure 102a, and second therapy delivery portion 106 is advanced into a body cavity of the patient. In such cases, the medical practitioner can perform acts on the patient while the patient’s pelvic region is substantially immobilized because the articulable surgical instrument 100 is affixed to the surgical table. Even if the surgical table is inclined, for example, the adjustable disc 108 can prevent the patient’s body from migrating downward toward the proximal end 106p of the second therapy delivery portion 106, and the affixation of the articulable surgical instrument 100 to the surgical table can prevent the patient’s body from moving at all on the surgical table. [0069] The orientation sub-structure 124 of the first handle attachment structure 102a may be arranged as a boss, a protrusion, a button, an aperture, a groove, a slot, a fork, or some other structure. The orientation sub-structure 124 may be used as a guide to help secure the first handle portion 102 to the surgical table in some cases, and these or other cases, the orientation substructure 124 may be an integral portion of a releasable locking mechanism. [0070] In some cases, the first handle portion 102 is between about one inch (1.0 in.) and about eighteen inches (18.0 in.). Shorter and longer lengths are contemplated. In at least some cases, the length of the first handle portion 102 is associated with the type of surgical procedure that will be performed with the articulable surgical instrument 100. In these or other cases, the length of the first handle portion 102 is associated with the type of patient (e.g., human, large mammal (e g., elephant, gorilla, bovine, swine, and the like), small mammal (e.g., goat, dog, cat, and the like)) that will be operated on using the articulable surgical instrument 100. Other considerations of course may be used to select an acceptable length of the first handle portion 102. In at least one embodiment, the first handle portion 102 is between about six and ten inches long (6.0 in. to 10.0 in.).

[0071] In some cases, at least part of the first handle portion 102 has a substantially cylindrical shape with a circular cross section. In such cases, the cross-sectional diameter of the substantially cylindrical part of the first handle portion 102 may be between about one-quarter inch and about four inches (0.25 in. to 4.0 in.). In other cases, the cross-sectional diameter may be smaller or larger. In at least one case, the cross-sectional diameter of the substantially cylindrical part of the first handle portion 102 is between about three fourths of an inch and about one and one-half inches (0.75 in. to 1.5 in.). The selected cross-sectional diameter may be chosen using same or similar criteria as for choosing the length of the first handle portion 102. Those of skill in the art will recognize that the first handle portion 102 may have another shape rather than substantially cylindrical. Along these lines, the cross-sectional shape may be square, rectangular, hexagonal, or some other symmetrical or non-sym metrical shape.

[0072] As evident in the Views of FIG. 4, the first handle portion 102 may have one or more bends, curvatures, arcs, or other shapes. In the embodiment of FIG. 4, the first handle portion 102 has a two complementary bends in a single plane (e.g., an “S” curve). The selected bends moves the central portion of the first handle portion 102 off true by a distance of between about one- eighth and one-half of its length with the first bend beginning at the end of the first handle attachment structure 102a and the second bend beginning about the middle of the first handle portion 102. The first bend moves the first handle portion 102 from its original axis, and the second bend returns the first handle portion 102 to an axis parallel to the original axis in one plane and identical to the original axis in another plane. The first bend selected in the embodiment of FIG. 4 has an angle of between about thirty degrees and about sixty degrees (30° to 60°), and the second bend has a complementary angle of between about three-hundred-thirty degrees and about three-hundred degrees (330° to 300°). Other shapes, arcs, diameters, distances, angles, and such parameters are of course contemplated, and the shapes and sizes represented in FIG. 4 are not limiting.

[0073] In FIG. 4, the ball structure 118 and the lower seat structure 120 are associated with the first handle portion 102. This is optional, and as will be evident to one of skill in the art, a seating structure and a ball structure may alternatively be associated with a second therapy delivery portion 106. [0074] FIG. 5A is six elevation views of a knuckle collar 104 of an articulable surgical instrument 100. FIG. 5B is four axonometric views of the knuckle collar 104 of the articulable surgical instrument 100.

[0075] The knuckle collar 104 is formed partially or entirely from one or more suitable medical materials in any desired composition. The knuckle collar 104 may be sterilizable e.g., cleaned to a medically acceptable state via any known sterilization apparatus and technique such as, but not limited to, an autoclave, a steam autoclave, a dry heat oven, and liquid or gaseous chemical bath, and ultraviolet light). Additionally, or in the alternative, the knuckle collar 104 may be disposable.

[0076] In at least some cases, the knuckle collar 104 has at least one textured surface. The texture may be a knurled surface, a ribbed surface, an abraded surface, or some other texture that facilitates friction when the articulable surgical instrument 100 is manually manipulated. In other cases, the knuckle collar 104 may have at least one smooth surface with reduced friction that facilitates easier and more comfortable rotation of the knuckle collar 104 for tightening or loosening the lockable ball joint of the articulable surgical instrument 100. In at least one case, the knuckle collar 104 has a knuckle collar .contoured for single thumb rotation 104s that facilitates tightening (e.g., locking) or loosening (e.g., unlocking) of the lockable ball joint with one hand (e.g., the thumb of one hand), and such manipulation may be performed in light or darkness and in view of a medical practitioner or even when the view of the medical practitioner is obstructed.

[0077] In some cases, the knuckle collar 104 is between about one inch (1 .0 in.) and about three inches (3.0 in.). Shorter and longer lengths are contemplated. In at least some cases, the length of the knuckle collar 104 is associated with the type of surgical procedure that will be performed with the articulable surgical instrument 100. In these or other cases, the length of the knuckle collar 104 is associated with the type of patient (e.g., human, large mammal (e.g., elephant, gorilla, bovine, swine, and the like), small mammal (e.g., goat, dog, cat, and the like)) that will be operated on using the articulable surgical instrument 100. Other considerations of course may be used to select an acceptable length of the knuckle collar 104. In at least one embodiment, the knuckle collar 104 is between about six and ten inches long (6.0 in. to 10.0 in.). [0078] In some cases, at least part of the knuckle collar 104 has a substantially cylindrical shape with a circular cross section. In such cases, the cross-sectional diameter of the substantially cylindrical part of the knuckle collar 104 may be between about one-quarter inch and about four inches (0.25 in. to 4.0 in.). In other cases, the cross-sectional diameter may be smaller or larger. In at least one case, the cross-sectional diameter of the substantially cylindrical part of the knuckle collar 104 is between about three fourths of an inch and about one and two inches (0.75 in. to 2.0 in.). The selected cross-sectional diameter may be chosen using same or similar criteria as for choosing the length of the knuckle collar 104. Those of skill in the art will recognize that the knuckle collar 104 may have another shape rather than substantially cylindrical. Along these lines, the cross-sectional shape may be square, rectangular, hexagonal, or some other symmetrical or non-symmetrical shape.

[0079] As evident in the Views of FIG. 5, the knuckle collar 104 may have one or more bends, curvatures, arcs, or other shapes. In the embodiment of FIG. 6, the knuckle collar 104 has a single arc in a single direction. The selected arc moves the distal end 106d of the knuckle collar 104 off true by a distance of between about one-eighth and one-half of its length with the arc beginning about the middle of the knuckle collar 104. The arc selected for the embodiment of FIG. 6 has a diameter of between about the length of the knuckle collar 104 and about four times the length of the knuckle collar 104. Other shapes, arcs, diameters, distances, and such parameters are of course contemplated, and the shapes and sizes represented in FIG. 5 are not limiting. [0080] In at least one case, the knuckle collar 104 includes an internal thread structure 104t arranged to receive a complimentary external thread structure 106t (FIG. 6) formed at the proximal end 106p of the second therapy delivery portion 106. The cooperative thread patterns may have any suitable dimension and precision. In at least one case, the matching thread pattern is a fine thread pattern at sixteen threads per inch (16 TPI). In other cases, the TPI may be higher or lower. In other cases, the thread pattern may be a coarse thread pattern.

[0081] Turning back to the exploded diagrams of FIG. 2, one of skill in the art will understand that the stem 118s (FIG. 8) of the ball structure 118 can be passed through the knuckle collar 104 and threaded or otherwise coupled to the first handle portion 102 or optionally to the lower seat structure 120. This is possible because the diameter of the opening at the distal end 104d of the knuckle collar 104 is greater than the diameter of the ball 118b of the ball structure 118 and greater than the diameter of the opening at the proximal end 104p of the knuckle collar 104. Also in this configuration, the knuckle collar 104 can be loosely threaded onto the second therapy delivery portion 106. In this way, before the knuckle collar 104 is tightened, but after the knuckle collar 104 is joined to both the first handle portion 102 and the second therapy delivery portion 106, the first handle portion 102 and the second therapy delivery portion 106 of the articulable surgical instrument 100 may be moved relative to each other (FIG. 3). To facilitate at least some of this movement, the proximal end 104p of the knuckle collar 104 has an external taper 104e that is arranged to cooperate with the internal cradle 120c of the lower seat structure 120. In some cases, there is direct contact between the external taper 104e and the internal cradle 120c; in other cases, the two profiles are in close proximity to each other without any direct conflict.

[0082] Considering further the case where the first handle portion 102 and the second therapy delivery portion 106 are loosely and movably joined together by the knuckle collar 104, a semispherical lower portion 1181 of the ball structure 118 (FIG. 8A) will seat into an internal cradle 104c of the knuckle collar 104, and as the knuckle collar 104 is tightened, the proximal end 106p of the second therapy delivery portion 106 will be drawn toward the semispherical upper portion 118u of the ball structure 118 (FIGS. 6, 8). The proximal end 106p of the second therapy delivery portion 106 will in some embodiments have an internal cradle 106c that mates with the semispherical upper portion 118u of the ball structure 118 (FIGS. 6, 8). Subsequently, as the knuckle collar 104 is tightened, the internal cradle 104c of the knuckle collar 104 will be drawn more tightly to the semispherical lower portion 118I of the ball structure 118, and the internal cradle 106c of the second therapy delivery portion 106 will be drawn more tightly to the semispherical upper portion 118u of the ball structure 118 thereby forming a lockable ball joint. Upon sufficient tightening (e.g., one to two foot-pounds in some cases, but lower torque or higher torque is also contemplated), the relative position of the first handle portion 102 to the second therapy delivery portion 106 will be fixed.

[0083] In the present disclosure, several taper structures and several cooperative mating (e.g., cradling) structures are illustrated and described. A non-limiting, non-exhaustive list of such structures includes a cradle that is shown in FIG. 2A but not expressly referenced at the distal end of the first handle portion 102, the internal cradle 104c of the knuckle collar 104, the external taper 104e fo the knuckle collar 104, and the internal cradle 106c of the second therapy delivery portion 106. The taper structures and the cradle structures may individually or collectively be formed in accordance with a linear taper, an arcuate or bowl-shaped taper, a semispherical hollow, or more generally, a continuous, uniform, or algorithmically determined increase or decrease in diameter of a circular or semicircular portion of a subject structure. The tapers and cradles may be in direct contact with each other, indirect contact, or not in contact at all.

[0084] In some cases, a liner (not shown) may be positioned between a taper and its cooperative cradle. The liner may be formed of any suitable material (e.g., silicon, rubber, Teflon, plastic, or some other material). In some cases, the liner reduces friction or otherwise promotes easier movement between the structures. In other cases, the liner increases friction to restrict movement between the structures. In still other cases, the liner promotes motion between the structures under low pressure or in the absence of pressure, and the line also restricts motion in the presence of higher pressure that is intended to temporarily “lock” the structures in place when the articulable surgical instrument. The liner may be permanent or disposable. The liner may be a separate and distinct structure in some cases, and the liner may be a coating (e.g., sprayed on, anodized, deposited, painted, or the like) in other cases. The liner may be sterilizable (e.g., cleaned to a medically acceptable state via any known sterilization apparatus and technique such as, but not limited to, an autoclave, a steam autoclave, a dry heat oven, and liquid or gaseous chemical bath, and ultraviolet light). Other means of permitting motion, restricting motion, and forming one or more suitable locking structures are also contemplated.

[0085] FIG. 6A is six elevation views of a second therapy delivery portion 106 of an articulable surgical instrument 100. FIG. 6B is four axonometric views of the second therapy delivery portion 104 of the articulable surgical instrument 100.

[0086] The second therapy delivery portion 106 is formed partially or entirely from suitable medical materials in any desired composition. The second therapy delivery portion 106 may be sterilizable (e.g., cleaned to a medically acceptable state via any known sterilization apparatus and technique such as, but not limited to, an autoclave, a steam autoclave, a dry heat oven, and liquid or gaseous chemical bath, and ultraviolet light). Additionally, or in the alternative, the second therapy delivery portion 106 may be disposable.

[0087] In at least some cases, the second therapy delivery portion 106 has at least one textured surface. The texture may be a knurled surface, a ribbed surface, an abraded surface, or some other texture that facilitates friction when the articulable surgical instrument 100 is manually manipulated. In other cases, the second therapy delivery portion 106 may have at least one smooth surface with reduced friction that facilitates easier and more comfortable advancement and withdrawal of the second therapy delivery portion 106 into the body of a patient.

[0088] In at least one case, the second therapy delivery portion 106 includes a thread structure arranged to receive an optional adjustable disc 108, an optional locking structure 110, or some other structure. In such case, and optionally in other cases, the thread structure may be a large thread structure (e.g., greater than one-thirty-second of an inch (0.03125 in.) that has substantially smooth, lowered friction edges. In this way, the optional structures may still be advanced and withdrawn from the body of the second therapy delivery portion 106, and the second therapy delivery portion 106 may be easily advanced and withdrawn from the body of the patient.

[0089] In some cases, the second therapy delivery portion 106 is between about one inch (1 .0 in.) and about eighteen inches (18.0 in.). Shorter and longer lengths are contemplated. In at least some cases, the length of the second therapy delivery portion 106 is associated with the type of surgical procedure that will be performed with the articulable surgical instrument 100. In these or other cases, the length of the second therapy delivery portion 106 is associated with the type of patient (e.g., human, large mammal (e.g., elephant, gorilla, bovine, swine, and the like), small mammal (e.g., goat, dog, cat, and the like)) that will be operated on using the articulable surgical instrument 100. Other considerations of course may be used to select an acceptable length of the second therapy delivery portion 106. In at least one embodiment, the second therapy delivery portion 106 is between about six and ten inches long (6.0 in. to 10.0 in.).

[0090] In some cases, at least part of the second therapy delivery portion 106 has a substantially cylindrical shape with a circular cross section. In such cases, the cross-sectional diameter of the substantially cylindrical part of the second therapy delivery portion 106 may be between about one-quarter inch and about four inches (0.25 in. to 4.0 in.). In other cases, the cross-sectional diameter may be smaller or larger. In at least one case, the cross-sectional diameter of the substantially cylindrical part of the second therapy delivery portion 106 is between about three fourths of an inch and about one and two inches (0.75 in. to 2.0 in.). The selected cross-sectional diameter may be chosen using same or similar criteria as for choosing the length of the second therapy delivery portion 106. Those of skill in the art will recognize that the second therapy delivery portion 106 may have another shape rather than substantially cylindrical. Along these lines, the cross-sectional shape may be square, rectangular, hexagonal, or some other symmetrical or non-sym metrical shape.

[0091] As evident in the Views of FIG. 6, the second therapy delivery portion 106 may have one or more bends, curvatures, arcs, or other shapes. In the embodiment of FIG. 6, the second therapy delivery portion 106 has a single arc in a single direction. The selected arc moves the distal end 106d of the second therapy delivery portion 106 off true by a distance of between about one-eighth and one-half of its length with the arc beginning about the middle of the second therapy delivery portion 106. The arc selected for the embodiment of FIG. 6 has a diameter of between about the length of the second therapy delivery portion 106 and about four times the length of the second therapy delivery portion 106. In some cases, the arcuate segment of the second therapy delivery portion 106 may be as depicted, and in these or other cases, the second therapy delivery portion 106 may have one or more other shapes, arcs, diameters, distances, and parameters that are not depicted in the figures of the present disclosure. Generally, the selected linear and non-linear, regular and irregular shapes of any portion of the articulable surgical instrument 100 embodiment are chosen to suit the patient anatomy.

[0092] The second therapy delivery portion 106 in the embodiment of FIG. 6 in at least one case includes an external thread structure 106t arranged to cooperatively mate with a corresponding internal thread structure 104t (FIG. 5) of the knuckle collar 104. In a first stage, the knuckle collar 104, which is already joined to the first handle portion 102 is loosely threaded (e.g., screwed) onto the second therapy delivery portion 106. This loose threading permits the first handle portion 102 and the second therapy delivery portion 106 to be rotated or otherwise positioned relative to each other. Once a suitable positioning is attained, the knuckle collar 104 is further tightened to more fixedly retain the desired positioning. One of skill in the art will recognized that the knuckle collar of this lockable ball joint may be suitably tightened to any desired level to control how rigidly the positioning of the first handle portion 102 and the second therapy delivery portion 106 will be maintained during a surgical procedure. The knuckle collar 104 may be tightened and loosened at will by a medical practitioner any number of times before, during, and after a surgical procedure.

[0093] The thread pattern of the external thread structure 106t may have any suitable dimension and precision. In at least one case, the thread pattern is a fine thread pattern at sixteen threads per inch (16 TPI). In other cases, the TPI may be higher or lower. In other cases, the thread pattern may be a coarse thread pattern. Generally, the thread pattern of the external thread structure 106t will diametrically match the thread pattern of the internal thread structure 104t of the knuckle collar.

[0094] As one of skill in the art will recognize, and as otherwise discussed herein, the articulable surgical instrument 100 embodiments represented in the present disclosure include a first handle portion 106 coupled at a stem 118s of a ball structure 108 with knuckle collar 104 at the ball 118b of the ball structure 118. The knuckle collar 104 is further coupled via an internal thread structure 104t to an external thread structure 106t of the second therapy deliver portion 106. In other embodiments, however, the structures may be coupled in different ways. For example, unless expressly claimed in a particular organization, the ball structure 118 may be coupled to either the first handle portion or the second therapy delivery portion. The ball structure may have a threaded stem, a stem integrated with either the first or second portion, a stem welded or permanently joined to the first or second portion in another way, or yet some other configuration. Along these lines, the coupling arrangement of the knuckle collar 104 to the first handle portion 102 and the second therapy delivery portion 106 may be reversed or organized in some other way.

[0095] In at least one case, for example, a lockable ball joint as discussed herein may also be formed with a ball structure 118 formed as an unattached spherical or semi-spherical structure positionable between the first handle portion 102 and the second therapy delivery portion 106 wherein the spherical or semi-spherical structure is held in place by the knuckle collar 104. In these or other cases, the ball structure 118 may be formed of suitable medical materials in any desired composition. The knuckle collar may include a ring, a gasket, a set of protuberances, or some other means joined to an inner surface of the knuckle collar 104 and arranged to permit motion of the ball structure 118 while retaining the ball structure 118 inside the knuckle collar 104. In such type of of arrangement, the ball structure will naturally align in the internal cradle 104c of the knuckle collar 104 and the internal cradle 106c of the second therapy delivery portion 106 when the knuckle collar 104 is tightened (/.e., during formation of the lockable ball joint).

[0096] The full length of the tool channel 112 in one embodiment of an articulable surgical instrument 100 is clear in the Bottom View of the second therapy delivery portion 106 in FIG. 6A. The full depth of the tool channel 112 in one embodiment of an articulable surgical instrument 100 is clear in the Second Axonometric View of the second therapy delivery portion 106 in FIG. 6B. In the embodiment illustrated in FIG. 6, the tool channel is formed as a substantially straight channel having a width of between about one-eighth of an inch and about three-fourths of an inch (0.125 in. and 0.75 in.) and a depth of between about one-fourth of an inch and about one-and-three-quarters of an inch (0.25 in. and 1.75 in.) at its deepest point. Other dimensions are of course contemplated, and in other cases, the tool channel 112 may include one or more straight (/.e., linear) segments, curved segments, tapered segments, particularly shaped segments, and combinations of different types of segments, and still other configurations. The tool channel may be arranged to receive probes, clamps, cameras, scopes, sensors, cutting tools, cauterizing tools, suturing tools, and many other types of tools that are now used, or will be used in the future, in the surgical theater.

[0097] One of skill in the art will recognize that an articulable surgical instrument 100 may have two or more tool channels. One of skill in the art will recognize that an articulable surgical instrument 100 may have tool channels having access exposed throughout the entire length of the channel as in FIG. 6, but in other cases, one or more tool channels 112 may be formed, bored, drilled, or otherwise tunneled through some or all of the second therapy delivery portion 106.

[0098] The tool channel 112 may have a slot 112s at its origin in the proximal end 106p of the second therapy delivery portion 106. In some cases, the slot 112s is formed as a result of cutting a linear tool channel 112 through a curved section of the second therapy delivery portion 106. In other cases, the slot 112s is formed purposefully to facilitate entry of a surgical tool into the channel. Beneficially, the slot 112s may permit the medical practitioner more clearance, space, or other access to manipulation of a surgical tool that is passed through the tool channel 112.

[0099] In some embodiments, the tool channel 112 may have a gap 112g at its termination in the distal end 106d of the second therapy delivery portion 106. In some cases, the gap 112g is formed as a result of cutting a linear tool channel 112 through a curved or otherwise shaped section distal end 106d of the second therapy delivery portion 106. In other cases, the gap 112g is formed purposefully to facilitate a medical use of a surgical tool in the body cavity of the patient. Beneficially, the gap 112g may provide the medical practitioner with room, clearance, space, or other access to perform a particular type of surgical procedure (e.g., suturing, cooling, freezing, heating, cauterizing, sample collecting, irrigating, draining, suctioning, measuring, illuminating, imaging, probing, testing, or the like).

[0100] The therapy port 114 of the second therapy delivery portion 106 may be arranged having any suitable size, shape, boundaries, dimensions, or other parameters. For example, the therapy port 114 can be a surface indentation or can extend fully or partly through the second therapy delivery portion 106. In one particular embodiment, walls of the therapy port 114 are tapered in or out to define a surface for accommodating various anatomical features. The therapy port 114 can be square, rectangular, oval, circular, triangular, or another shape. The therapy port 114 can be positioned further towards the distal end 106d or further towards the proximal end 106p. The therapy port 114 can extend further along a length of the arcuate segment of the second therapy delivery portion 106 or can be shortened. Additionally, in some embodiments, the therapy port 114 can be adjustable in width, height, depth, diameter, or shape. In the embodiment of FIG. 6, the therapy port 114 is an aperture through the distal end 106d of the second therapy delivery portion 106. In other cases, the therapy port 114 may have a different arrangement. [0101] The therapy port 114 in FIG. 6 is arranged with a diameter of between about three-fourths of an inch and about one and one-half inch (0.75 in. to 1.5 in.). Other sizes are of course contemplated. As further evident in the various views of FIG. 6, the therapy port 114 may include tapers, curves, arcs, protuberances, slots, grooves, and the like as suitable for one or more particular medical procedures. In at least one case, the therapy port 114 includes a measurement scale (not shown) useful to a medical practitioner to measure a particular dimension (e.g., length, width, diameter, or the like) of a piece of biological material of the patient, a depth of insertion into the patient, or some other dimension. The measurement scale may, for example, be printed on or molded into the therapy port 114 or some other portion of the second therapy delivery portion 106 and used to approximately measure the size of a tumor, the positioning of sutures, the positioning of certain biological structures of the patient, or for some other purpose.

[0102] FIG. 7A is six elevation views of an adjustable disc 108 of an articulable surgical instrument 100 and six elevation views of a locking structure 110 of the articulable surgical instrument 100. FIG. 7B is four axonometric views of the adjustable disc 108 of the articulable surgical instrument 100 and four axonometric views of the locking structure 110 of the articulable surgical instrument 100. One or both of the adjustable disc 108 and the locking structure 110 are optional.

[0103] One or both of the adjustable disc 108 and the locking structure 110 are formed partially or entirely from suitable medical materials in any desired composition. One or both of the adjustable disc 108 and the locking structure 110 may be sterilizable (e.g., cleaned to a medically acceptable state via any known sterilization apparatus and technique such as, but not limited to, an autoclave, a steam autoclave, a dry heat oven, and liquid or gaseous chemical bath, and ultraviolet light). Additionally, or in the alternative, one or both of the adjustable disc 108 and the locking structure 110 may be disposable.

[0104] In at least some cases, one or both of the adjustable disc 108 and the locking structure 110 have at least one textured surface. The texture may be a knurled surface, a ribbed surface, an abraded surface, or some other texture that facilitates friction when one or both of the adjustable disc 108 and the locking structure 110 are manually manipulated. In other cases, one or both of the adjustable disc 108 and the locking structure 110 may have at least one smooth surface with reduced friction that facilitates more comfortable advancement and withdrawal of the adjustable disc 108 or the locking structure 110 along the length of the second therapy delivery portion 106. In these or other cases, one or both of the adjustable disc 108 and the locking structure 110 may have tapered edges, rounded edges, flattened edges, or any other suitable features that provide comfort or other functionality to the patient, the medical practitioner, or surgical procedure.

[0105] In at least one case, one or both of the optional adjustable disc 108 and the optional locking structure 110 are threaded onto a thread structure formed along some or all of the length of the external surface of the second therapy delivery portion 106. In such case, and optionally in other cases, one or both of the adjustable disc 108 and the locking structure 110 have an internal thread structure appropriately sized (e.g., greater than one-thirty-second of an inch (0.03125 in.) to the corresponding threads of the second therapy delivery portion 106.

[0106] In some cases, one or both of the adjustable disc 108 and the locking structure 110 are formed as circular discs. In other cases, one or both of the adjustable disc 108 and the locking structure 110 are formed having a square shape, a hexagonal shape, a teardrop shape, or some other shape. The cross-structure dimension (e.g., diameter, length, width, or the like) of one or both of the adjustable disc 108 and the locking structure 110 may be between about one inch and about six inches (1 .0 in. to 6.0 in.). Shorter and longer dimensions are contemplated and cases where the adjustable disc 108 and the locking structure 110 have different dimensions are contemplated. [0107] In some cases, the adjustable disc 108 is advanced on the second therapy delivery portion 106, and once suitably positioned by the medical practitioner, the locking structure 110 is also advanced on the second therapy delivery portion 106. The optional locking structure 110, when used, is arranged to keep the adjustable disc 108 from rotationally migrating from its original position.

[0108] In some cases, the adjustable disc 108 may be sized and positioned to prevent advancing the second therapy delivery portion 106 too far into the patient. In these or other cases, the advancement of the second therapy delivery portion 106 too far into the patient may be caused by the medical practitioner manually pushing the second therapy delivery portion 106 too far. In addition, or in the alternative, the advancement of the second therapy delivery portion 106 too far into the patient may be caused by the patient “sliding” down the surgical table or other platform during the medical procedure. Such sliding may be caused by gravity, an incline of the surgical table, manipulation of the biological tissue by the medical practitioner or some other cause.

[0109] In some cases, one or both of the adjustable disc 108 and the locking structure 110 includes a slot 108s, 110s (e g., a discontinuity, a cutaway, or some other pass-through structure) arranged for alignment with the tool channel 112. In at least one case, the internal thread patterns of the adjustable disc 108 and the locking structure 110 are offset from each other to permit the respective slots 108s, 110s of both the adjustable disc 108 and the locking structure 110 to align with the tool channel 112 when the locking structure 110 is firmly abutting the adjustable disc 108.

[0110] In at least some cases, the slot 108s, 110s of one or both of the adjustable disc 108 and the locking structure 110 is arranged at an angular offset. That is, in the case that one or both of the adjustable disc 108 and the locking structure 110 is arranged as a disc, the respective slot 108s, 110s may in some cases be cut perpendicularly across the shortest boundary of the disc, and in other cases, such as represented in the Bottom View and Top View of FIG. 7A, the respective slot 108s, 110s may be cut diagonally across the shortest boundary of the disc. This offset angle may be arranged to align with an angular formation of a tool channel 112 (e.g., the Bottom View of FIG. 6A). The offset angle in at least some cases is between thirty and sixty degrees (30° to 60°), however, other angles are also contemplated.

[0111] The respective slots 108s, 110s are optional. In operation, the slot 108s of the adjustable disc 108 and slot 110s of the locking structure 110 permit a medical practitioner to have full access to an exposed tool channel 112. In embodiments where the second therapy delivery portion 106 does not have a tool channel 112 or where the tool channel 112 is fully or partially formed internal to the second therapy delivery portion 106, the slots 108s, 110s, may not be necessary.

[0112] FIG. 8A is six elevation views of a ball structure 118 of an articulable surgical instrument 100 and six elevation views of an optional lower seat structure 120 of the articulable surgical instrument 100. FIG. 8B is four axonometric views of the ball structure 118 of the articulable surgical instrument 100 and four axonometric views of the optional lower seat structure 120 of the articulable surgical instrument 100.

[0113] One or both of the ball structure 118 and the lower seat structure

120 are formed partially or entirely from suitable medical materials in any desired composition. One or both of the ball structure 118 and the lower seat structure 120 may be sterilizable (e.g., cleaned to a medically acceptable state via any known sterilization apparatus and technique such as, but not limited to, an autoclave, a steam autoclave, a dry heat oven, and liquid or gaseous chemical bath, and ultraviolet light). Additionally, or in the alternative, one or both of the ball structure 118 and the lower seat structure 120 may be disposable. [0114] In at least some cases, the lower seat structure 120 has at least one textured surface. The texture may be a knurled surface, a ribbed surface, an abraded surface, or some other texture that facilitates friction when the articulable surgical instrument 100 is manually manipulated. In other cases, the lower seat structure 120 has at least one smooth surface with reduced friction that facilitates more comfortable use of the articulable surgical instrument 100. [0115] The ball structure 118 of FIG. 8 includes a ball 118b (e.g., a sphere, a semi-sphere, a sphere-like portion, a generally spherical structure, and the like) and stem 118s. The ball 118b may be understood as including a semispherical lower portion 1181 and a semispherical upper portion 118u. One or both of the semispherical portions 118I, 118u may be half-spheres, partial spheres, or some other structure having at least one portion arranged with a surface profile that inversely maps to the surface profile of a corresponding cradle structure. Along these lines, it is understood that the ball structure 118 of the present disclosure has a spherical shape or spherical portions, but a ball structure 118 in other embodiments may or may not be spherical. For example, parabolic, cylindrical, and other ball structures having different shapes are also contemplated.

[0116] As described herein, some articulable surgical instrument 100 embodiments include a lockable ball joint formed with a ball structure 118 that does not have a stem 118b. In these and other cases, the ball structure 118 may be an unattached sphere or a structure having some other shape. Generally in these cases, the ball structure 118b is contained within the knuckle collar 104 by any suitable means. When the knuckle collar 104 is tightened, the lockable ball joint is engaged to create a first high friction region between a semispherical lower portion 118I of the ball structure 118 and the internal cradle 104c of the knuckle collar 104 and a second high friction region between a semispherical upper portion 118u of the ball structure 118 and the internal cradle 106c (e.g., a semispherical hollow) of the second therapy delivery portion 106. [0117] The lower seat structure 120 has a cradle 120c. The surface profile of the cradle 120c in some cases inversely matches an external taper 104e of the knuckle collar 104. In some embodiments where the optional lower seat structure 120 is not included, a cradle along the lines of cradle 120c is formed in the distal end 102d of the first handle portion 102.

[0118] In at least some cases the stem 118s of the ball structure 118 and the lower seat structure 120 include a means for coupling the ball structure 118 to the first lower handle portion 102. In the embodiment of FIG. 8, the coupling means includes a shaped nut 118n of the ball structure and a correspondingly shaped well 120w of the lower seat structure 120. In some cases, during assembly of the articulable surgical instrument 100, the ball structure 118 is positioned such that the shaped nut 118n is seated in the cooperatively shaped well 120w of the lower seat structure 120. In this way, the threaded stem 118s of the ball structure 118 may be threaded onto the first handle portion 102 wherein the lower seat structure 120 operates as a wrench to firmly secure the ball structure 118 into the first handle portion 102.

[0119] FIG. 9A is a first perspective view of an articulable surgical instrument 100 embodiment in use with a surgical tool 126, and FIG. 9B is a second perspective view of the articulable surgical instrument 100 of FIG. 9A in use with the surgical tool 126. Other structures of the articulable surgical instrument 100 of FIG. 9 are not labeled to avoid unnecessarily cluttering the figures. Nevertheless, such structures will be readily understood by one of skill in the art via FIGS. 1-8 and the corresponding discussion herein.

[0120] The surgical tool 126 of FIG. 9 is a tenaculum, but a wide range of other surgical tools may additionally or alternatively be used with the articulable surgical instrument embodiments taught in the present disclosure. Such surgical tools 126 may be passed into the body of a patient via the tool channel 112. In this way, one or more embodiments of such articulable surgical instruments 100 may be suitably arranged for pelvic surgical procedures, vaginal surgical procedures, anal surgical procedures, gastric surgical procedures, cranial surgical procedures, orthopedic surgical procedures, or some other type of surgery.

[0121] In the embodiment of FIG. 9, an articulable surgical instrument 100 may be used to facilitate accuracy of graft placement and the timely completion of sacrocolpopexy-type procedures. For example, some patients may have weakened or damaged pelvic floor muscles, connective tissue, ligaments and skin, often related to past pregnancy, childbirth, genetic factors, or other reasons. The weakened or damaged connective tissue, muscles, and ligaments fail to provide adequate support to the vagina, cervix, uterus, and pelvic floor, which may lead to excessive movement of these anatomical structures and a migration or “falling” away from a normal position in a patient’s body. In some cases, this condition may be referred to medically as uterovaginal prolapse, pelvic prolapse, pelvic organ prolapse, or some other like term. Prolapse of this sort may cause symptoms and dysfunction of related and/or proximate organs. A first type of prolapse of the vagina and pelvic floor may involve a weakened anterior vaginal portion, which normally supports the bladder, causing the anterior vaginal wall, bladder, and ureters to be displaced downward toward, or out through, the vaginal opening. A second type of prolapse involves the apical portion, which is the deepest “inside” or top portion of the vagina, and the cervix with uterus, if one or both are present. Many patients who have previously had a hysterectomy, including removal of one or both of the uterus and cervix, are predisposed to vaginal prolapse. In this condition, the apical portion of the vagina, with uterus and cervix, if present, descend toward or out through the vaginal opening. A third type of prolapse involves the posterior vaginal wall and rectum, which may descend downward toward, or out through, the vaginal opening. A fourth type of prolapse involves the perineal body, which is a pyramid-shaped structure between the most distal portion of the vagina and anus. In this fourth type of prolapse, the perineal body becomes weakened and detached from its supporting connective tissue, muscles, ligaments, or skin, which leads to excessive movement of the perineal body and entire pelvic floor. A fifth type of prolapse, which may be referred to as rectal prolapse, is a condition where the lowest part of the large intestine (/.e., the rectum) protrudes through the anus. Each of these types of prolapse, and other types of prolapse that are known to those of skill in the art but not discussed in detail herein, may occur singly or together in any combination. [0122] Prolapse conditions as described herein and otherwise known to those of skill in the art can sometimes be surgically corrected using the articulable surgical instrument 100 embodiments taught herein. In one exemplary case, a surgery is performed using an articulable surgical instrument 100 to reposition the prolapsed vagina during a vaginal prolapse correction procedure. In such case, a medical practitioner may grasp the first handle portion 102 and insert the second therapy delivery portion 106 into the vagina of the patient at a desired angle and to a desired depth of insertion. The knuckle collar 104 may be suitably tightened, loosened, or tightened and loosened as needed to move, rotate, or otherwise position the first handle portion 102 relative to the second therapy delivery portion 106. In at least some cases, the first handle portion 102 may be affixed to the surgical table. In a same or subsequent set of acts of the procedure, one or both of an adjustable disc 108 and a locking structure 110 may be positioned on the threaded segment of the second therapy delivery portion 106 by rotating a threaded bore of the adjustable disc 108 onto the threads of the second therapy delivery portion 106 until the disc is adjacent the patient’s perineal body. Such positioning of the adjustable disc 108 may be performed to inhibit any further depth of insertion. After the second therapy delivery portion 106 is appropriately inserted and positioned, the medical practitioner can reposition vaginal prolapse during a prolapse repair procedure or a pelvic reconstructive surgery.

[0123] In a more specific exemplary uses of an articulable surgical instrument 100 embodiment, a patient is anesthetized in an surgical suite. The patient is placed in the dorsal lithotomy position with the patient’s feet and legs in stirrups or other such leg supporting devices. The patient’s hips will be slightly flexed and abducted to allow visualization of the perineum and vaginal opening, and the patient’s knees will be slightly flexed. This positioning of the patient reduces the chance of injury to joints, muscles, and nerves during the surgical procedure, which may last one to four or more hours. Subsequently, an open-sided speculum is placed into the vagina to a selected depth, which may be the depth of the cervix. The speculum is then opened to expose the cervix to the medical practitioner’s line of sight. While holding the first handle portion 102 of the articulable surgical instrument 100 in one hand, the medical practitioner can then pass the clamping portion of the tenaculum through the therapy port 114 in the direction of posterior to anterior. The medical practitioner then securely grasps the cervix with the tenaculum’s sharp tips by squeezing the tenaculum handle closed while the sharp tips are in the cervical tissue. At this time in the procedure, the second therapy delivery portion 106 is not yet inside the vagina because the speculum is in the vagina and, in many cases, both devices cannot be in that location concomitantly. In a next act of the procedure, the open-sided speculum is removed from the vagina. The tenaculum, which is passed through the therapy port 114 of the articulable surgical instrument 100, remains in the vagina. In a next act, the medical practitioner grasps the first handle portion 102 of the articulable surgical instrument 100 and brings the second therapy delivery portion 106 into alignment with the vagina. The second therapy delivery portion 106 is introduced into the vagina and guided into a suitable position using the tenaculum which is concurrently held by the medical practitioner until the cervix is seated through the therapy port 114. In some cases, this positioning of the second therapy delivery portion 106 is done by "feel" rather than by sight.

[0124] Continuing with the descriptive acts of the present procedure, the second therapy delivery portion 106 of the articulable surgical instrument 100 has been advanced into the patient’s vagina to a desired initial insertion depth. The knuckle collar 104 may now be, or have previously been, tightened, loosened, or both any number of times to suitably orient the first handle portion 102, the second therapy delivery portion 106, and the patient’s anatomy. Upon such suitable orientation, the knuckle collar 104 is tightened to secure the lockable ball joint in the desired position. Concurrently, or slightly before or after, the optional adjustable disc 120, if used, may be advanced on the external threads of the second therapy delivery portion 106 to a position adjacent the patient’s perineal body. The optional locking structure 110 may also be put in place as taught herein. The tenaculum, which has been slightly deviated to a position alongside of the second therapy delivery portion 106 during insertion of the second therapy delivery portion 106, can now be moved into the tool channel 112, which results in the surgical tool 126 (/.e., tenaculum) positioned in parallel to the second therapy delivery portion axis 130t. Along these lines, one of skill in the art will recognize that many other types of surgical tools (e.g., retractors, open-sided speculum, etc.) may be used in the vaginal canal, which may, among other things, allow concomitant visualization and placement of the device into the apical compartment and possibly around the cervix.

[0125] In at least one execution of the present procedure, the wide portion of the tenaculum handle (/.e., the portion with finger holes) is held by the medical practitioner’s right hand in a position above (/.e., anterior to) the medical practitioner’s left hand, which is holding the first handle portion 106. At this point, the second therapy delivery portion 106 and the tenaculum are preferably positioned in the mid-sagittal plane and in alignment with the normal vaginal axis. Due to the laxity of the pelvic floor, or for other reasons, the medical practitioner may want to adjust the depth or orientation of the second therapy delivery portion 106. The medical practitioner can manipulate the knuckle collar 104 or suitably advance or withdraw the second therapy delivery portion 106 into, or from, the patient to a desired position, Via additional movement of the second therapy delivery portion 106 toward the patient's back or sacrum, an particularly using the shaped bolus 116, the medical practitioner can recreate normal anatomic positions of the vagina, pelvic floor, and other such anatomical structures. Once so positioned, the medical practitioner can complete the desired surgical procedure (e.g., suturing, grafting, cooling, freezing, heating, cauterizing, sample collecting, irrigating, draining, suctioning, measuring, illuminating, imaging, probing, testing, delivering gas or medication, or the like).

[0126] Having now set forth certain embodiments, further clarification of certain terms used herein may be helpful to providing a more complete understanding of that which is considered inventive in the present disclosure. [0127] In the embodiments of present disclosure, one or more particular structures are combined to form an articulable surgical instrument 100. The various components and structures of the embodiments are interchangeably described herein as “coupled,” “connected,” “attached,” and the like. It is recognized that once assembled, the junctions formed at the point where two or more structures meet in the present embodiments may be moved, flexible, and/or locked to a mechanically, medically, or otherwise surgically acceptable level.

[0128] In the absence of any specific clarification related to its express use in a particular context, where the terms “substantial” or “about” in any grammatical form are used as modifiers in the present disclosure and any appended claims (e.g., to modify a structure, a dimension, a measurement, or some other characteristic), it is understood that the characteristic may vary by up to 30 percent. For example, a second therapy delivery portion 106 may be described as being formed or otherwise oriented off axis by up to about forty- five degrees (45°). Different from the exact precision of the angle, 45°, the use of “substantially” or “about” is permitted to modify the characteristic by up to 30 percent. Accordingly, a second therapy delivery portion 106 that is oriented off axis by up to about forty-five degrees (45°) includes a second therapy delivery portion 106 oriented off axis between thirty-one and one-half degrees (31 .5°) and fifty-eight and one-half degrees (58.5°) degrees. A second therapy delivery portion 106 that is oriented off axis by only thirty degrees (30°), however, is not oriented off axis by about forty-five degrees (45°). As another example, a second therapy delivery portion 106 having a particular linear dimension of “between about six and ten inches long (6.0 in. to 10.0 in.)” includes such devices in which the linear dimension varies by up to 30 percent, Accordingly, the particular linear dimension of the second therapy delivery portion 106 may be between three inches and thirteen inches (3.0 in. to 13.0 in.).

[0129] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0130] Unless defined otherwise, the technical, medical, and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, a limited number of the exemplary methods and materials are described herein.

[0131] In the present disclosure, when an element (e.g., device, apparatus, structure, layer, material, or the like) is referred to as being “on,” “coupled to,” or “connected to” another element, the elements can be directly on, directly coupled to, or directly connected to each other, or intervening elements may be present. In contrast, when an element is referred to as being “directly on,” “directly coupled to,” or “directly connected to” another element, there are no intervening elements present.

[0132] The terms “include” and “comprise,” as well as derivatives and variations thereof, in all of their syntactic contexts, are to be construed without limitation in an open, inclusive sense, (e.g., “including, but not limited to”). The term “or,” is inclusive, meaning and/or. The phrases “associated with” and “associated therewith,” as well as derivatives thereof, can be understood as meaning to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have, have a property of, or the like.

[0133] Reference throughout this specification to “one embodiment” or “an embodiment” and variations thereof means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0134] In the present disclosure, the terms first, second, etc., may be used to describe various elements, however, these elements are not to be limited by these terms unless the context clearly requires such limitation. These terms are only used to distinguish one element from another. For example, a first machine could be termed a second machine, and, similarly, a second machine could be termed a first machine, without departing from the scope of the inventive concept.

[0135] The singular forms of “a,” “an,” and “the” in the present disclosure include plural referents unless the content and context clearly dictates otherwise. The conjunctive terms, “and” and “or,” are generally employed in the broadest sense to include “and/or” unless the content and context clearly dictates inclusivity or exclusivity as the case may be. The composition of “and” and “or” when recited herein as “and/or” encompasses an embodiment that includes all of the elements associated thereto and at least one more alternative embodiment that includes fewer than all of the elements associated thereto.

[0136] In the present disclosure, conjunctive lists make use of a comma, which may be known as an Oxford comma, a Harvard comma, a serial comma, or another like term. Such lists are intended to connect words, clauses, or sentences such that the thing following the comma is also included in the list. [0137] The headings and Abstract of the Disclosure provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0138] The articulable surgical instrument 100 embodiments taught in the present disclosure provide several technical effects and advances to the field of medicine, and surgery in particular.

[0139] Technical effects and benefits include the ability to reduce the cost and time, and to improve the consistency, reliability, and safety, of various prolapse and other surgical procedures. Some exemplary surgeries include uterovaginal or cervicovaginal prolapse correction procedures. Some surgeries include a pelvic reconstructive procedure such as sacrocolpopexy. Some surgeries include cervical support and delineation during cesarean hysterectomy to facilitate placement of cervical cerclage sutures for incompetent cervices, for example. Still other surgeries include open laparotomy surgeries to correct vaginal, uterovaginal and pelvic floor prolapse, hysterectomy, removal of adnexal structures, excision of endometriosis, paravaginal defect repair, myomectomy, laparotomy surgeries, recto-sigmoid prolapse correction surgeries, and other gynecologic diagnostic and therapeutic surgeries. Still other procedures known those of skill in the art can also be improved using embodiments of the articulable surgical instruments 100 taught herein.

[0140] Some embodiments of the articulable surgical instruments 100 can be configured for a surgical procedure that repositions a prolapsed uterine cervix and vagina during a uterovaginal or cervicovaginal prolapse correction procedure. In such cases, the medical practitioner can manipulate the structures of the articulable surgical instrument 100 to move or otherwise position one or more anatomical structures during a pelvic reconstructive procedure such as sacrocolpopexy or some other prolapse repair procedure. [0141] The present disclosure sets forth details of various structural embodiments that may be arranged to carry the teaching of the present disclosure. By taking advantage of the particularly configured and formed mechanical structures, a number of exemplary devices and systems are now disclosed.

[0142] Example A-1 is an articulable surgical instrument, comprising: a first handle portion; a second therapy delivery portion; and a knuckle collar articulably coupling the first handle portion to the second therapy delivery portion across a lockable ball joint.

[0143] Example A-2 may include the subject matter of any of Example A- 1 , and alternatively or additionally any other example herein, wherein the first handle portion includes a surgical table anchor.

[0144] Example A-3 may include the subject matter of any of Examples A-1 to A-2, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is formed from aluminum.

[0145] Example A-4 may include the subject matter of any of Examples A-1 to A-3, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is formed from a metal.

[0146] Example A-5 may include the subject matter of any of Examples A-1 to A-4, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is formed from an alloy including at least one of aluminum, steel, platinum, chromium, and copper.

[0147] Example A-6 may include the subject matter of any of Examples A-1 to A-5, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is formed from a plastic.

[0148] Example A-7 may include the subject matter of any of Examples A-1 to A-6, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is formed from a composite material. [0149] Example A-8 may include the subject matter of any of Examples A-1 to A-7, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is formed from a light transmissive material.

[0150] Example A-9 may include the subject matter of any of Examples A-1 to A-8, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is formed from a transparent or semi-transparent material.

[0151] Example A-10 may include the subject matter of any of Examples A-1 to A-9, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is sterilizable.

[0152] Example A-11 may include the subject matter of any of Examples A-1 to A-10, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion has at least one textured surface.

[0153] Example A-12 may include the subject matter of any of Examples A-1 to A-11 , and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is arranged for at least one of a pelvic surgical procedure, a vaginal surgical procedure, an anal surgical procedure, a gastric surgical procedure, a cranial surgical procedure, and an orthopedic surgical procedure.

[0154] Example A-13 may include the subject matter of any of Examples A-1 to A-12, and alternatively or additionally any other example herein, wherein the second therapy delivery portion is arranged for at least partial insertion into a body of a patient.

[0155] Example A-14 may include the subject matter of any of Examples A-1 to A-13, and alternatively or additionally any other example herein, wherein the second therapy delivery portion includes at least one channel arranged to pass at least one medical device. [0156] Example A-15 may include the subject matter of any of Examples A-1 to A-14, and alternatively or additionally any other example herein, wherein the second therapy delivery portion includes at least one aperture arranged to pass at least a portion of a medical device.

[0157] Example A-16 may include the subject matter of any of Examples

A-1 to A-15, and alternatively or additionally any other example herein, wherein the second therapy delivery portion has an integrated thread structure arranged to receive a patient safety device.

[0158] Example A-17 may include the subject matter of any of Examples A-1 to A-16, and alternatively or additionally any other example herein, wherein the second therapy delivery portion has an integrated thread structure arranged to receive a depth guide.

[0159] Example A-18 may include the subject matter of any of Examples A-1 to A-17, and alternatively or additionally any other example herein, wherein the lockable ball joint includes a first ball portion arranged to cooperate with one end of one of the first handle portion and the second therapy delivery portion, and wherein the lockable ball joint further includes a second ball portion arranged to cooperate with another end of the other of the first handle portion and the second therapy delivery portion.

[0160] Example A-19 may include the subject matter of any of Examples A-1 to A-18, and alternatively or additionally any other example herein, wherein the lockable ball joint includes an unattached spherical or semi-spherical structure positionable between the first handle portion and the second therapy delivery portion, said spherical or semi-spherical structure being held in place by the knuckle collar.

[0161] Example B-1 is a method of forming an articulable surgical instrument, comprising: providing a first handle portion having an elongated handle body with a proximal end and a distal end; providing a second therapy delivery portion having an elongated therapy delivery body; arranging a knuckle collar over a cooperating ball portion of a lockable ball joint; affixing a stem of the cooperating ball portion to one of the distal end of the elongated handle body and the proximal end of the elongated therapy delivery body; and removably coupling the knuckle collar to the other one of the distal end of the elongated handle body and the proximal end of the elongated therapy delivery body.

[0162] Example B-2 may include the subject matter of Example B-1 , and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is formed from a metal.

[0163] Example B-3 may include the subject matter of any of Examples B-1 to B-2, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy deliver portion is formed of an alloy that includes at least one of aluminum, platinum, chromium, copper, and steel.

[0164] Example B-4 may include the subject matter of any of Examples B-1 to B-3, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy deliver portion is formed of a plastic.

[0165] Example B-5 may include the subject matter of any of Examples B-1 to B-4, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy deliver portion is formed of a composite material.

[0166] Example B-6 may include the subject matter of any of Examples B-1 to B-5, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is formed from a light transmissive material, a substantially transparent material, or a substantially translucent material.

[0167] Example B-7 may include the subject matter of any of Examples B-1 to B-6, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy delivery portion is formed from a substantially opaque material, a light reflective material, and a substantially light absorptive material. [0168] Example B-8 may include the subject matter of any of Examples B-1 to B-7, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy deliver portion is arranged for sterilization.

[0169] Example B-9 may include the subject matter of any of Examples B-1 to B-8, and alternatively or additionally any other example herein, wherein at least one of the first handle portion and the second therapy deliver portion is disposable.

[0170] Example B-10 may include the subject matter of any of Examples B-1 to B-9, and alternatively or additionally any other example herein, wherein the first handle portion and the stem or the second therapy delivery portion and the stem are machined from a single piece of raw material.

[0171] Example B-11 may include the subject matter of any of Examples B-1 to B-10, and alternatively or additionally any other example herein, wherein knuckle collar and at least one of the first handle portion and the second therapy deliver portion are formed from a same material.

[0172] Example C-1 is a lockable ball joint for a surgical instrument, comprising: a stem arranged for attachment to a distal end of a first medical device portion; a ball-like portion affixed to the stem, the ball-like portion having a lower spherical portion at which the stem is affixed and an upper spherical portion arranged to cooperate with a proximal end of a second medical device portion; a generally cylindrical knuckle collar having a proximal end and a distal end, the proximal end of the generally cylindrical knuckle collar having an inside diameter X, and the distal end of the generally cylindrical knuckle collar having an inside diameter Y, wherein X is less than Y, wherein X is less than a diameter of the ball-like portion, wherein X is greater than a cross-sectional dimension of the stem, and wherein Y is greater than a diameter of the ball-like portion, wherein a thread structure is formed inside the generally cylindrical knuckle collar, the thread pattern arranged to receive a cooperative thread structure integrated in the proximal end of the second medical device portion, wherein the proximal end of the generally cylindrical knuckle collar has a first inside taper arranged to cooperate with the lower spherical portion of the balllike portion, wherein the proximal end of the generally cylindrical knuckle collar has a second outside taper arranged to cooperate with a mating surface of the distal end of a first medical device portion, and wherein the distal end of the generally cylindrical knuckle collar is arranged to receive the proximal end of the second medical device portion in such a manner that prior to tightening the generally cylindrical knuckle collar, the first and second medical device portions are permitted to rotate with respect to each other and further permitted to articulate with respect to each other, and that after tightening the generally cylindrical knuckle collar, the first and second medical device portions are temporarily fixed in a selected relationship to each other.

[0173] Example C-2 may include the subject matter of Example C-1 , and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar is hand tightened.

[0174] Example C-3 may include the subject matter of any of Examples C-1 to C-2, and alternatively or additionally any other example herein, wherein the second medical device portion is arranged with a semispherical hollow arranged to cooperate with the upper spherical portion of the ball-like portion after the generally cylindrical knuckle collar is tightened.

[0175] Example C-4 may include the subject matter of any of Examples C-1 to C-3, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar is formed from a metal.

[0176] Example C-5 may include the subject matter of any of Examples C-1 to C-4, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar is formed from a metal or an alloy that includes at least one of aluminum, platinum, gold, chromium, copper, and steel. [0177] Example C-6 may include the subject matter of any of Examples C-1 to C-5, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar is formed from a plastic material. [0178] Example C-7 may include the subject matter of any of Examples C-1 to C-6, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar is formed from a composite material.

[0179] Example C-8 may include the subject matter of any of Examples C-1 to C-7, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar is arranged for sterilization.

[0180] Example C-9 may include the subject matter of any of Examples C-1 to C-8, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar is disposable.

[0181] Example C-10 may include the subject matter of any of Examples C-1 to C-9, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar has an arcuate-shaped surface along at least part of its length to accommodate hand tightening.

[0182] Example C-11 may include the subject matter of any of Examples C-1 to C-10, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar has a knurled surface along at least part of its length to accommodate hand tightening.

[0183] Example C-12 may include the subject matter of any of Examples C-1 to C-11 , and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar is between about three-fourths of an inch long and about three inches long (0.75 in. to 3.0 in.).

[0184] Example C-13 may include the subject matter of any of Examples C-1 to C-12, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar is between about one inch long and one and one-half inches long (1 .0 in. to 1.5 in.).

[0185] Example C-14 may include the subject matter of any of Examples C-1 to C-13, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar has a diameter of between about one- half inch and about two inches (0.5 in. to 2.0 in.).

[0186] Example C-15 may include the subject matter of any of Examples C-1 to C-14, and alternatively or additionally any other example herein, wherein the generally cylindrical knuckle collar has a diameter of between about three- fourths of an inch and about one and one-quarter inches (0.75 in. to 1 .25 in.). [0187] Example C-16 may include the subject matter of any of Examples C-1 to C-15, and alternatively or additionally any other example herein, wherein the stem has a thread-structure integrated in its outer surface, and wherein the stem is arranged to be screwed into the distal end of the first medical device portion.

[0188] Example C-17 may include the subject matter of any of Examples C-1 to C-16, and alternatively or additionally any other example herein, wherein the stem is arranged for permanent affixation to the distal end of the first medical device portion.

[0189] Example C-18 may include the subject matter of any of Examples C-1 to C-17, and alternatively or additionally any other example herein, wherein the stem is integrated into a the distal end of the first medical device portion.

[0190] Example C-19 may include the subject matter of any of Examples C-1 to C-18, and alternatively or additionally any other example herein, wherein the stem has a circular cross section.

[0191] Example C-20 may include the subject matter of any of Examples C-1 to C-19, and alternatively or additionally any other example herein, wherein the stem has a triangular, square, rectangular, pentagonal, hexagonal, octagonal, or ovular cross section.

[0192] Example C-21 may include the subject matter of any of Examples C-1 to C-20, and alternatively or additionally any other example herein, wherein the stem has a length of between about one-half inch and about three inches (0.5 in. to 3.0 in.).

[0193] This application claims the benefit of priority to U.S. Provisional Application No. 63/269,040, filed March 8, 2022, which application is hereby incorporated by reference in its entirety.

[0194] In the description herein, specific details are set forth in order to provide a thorough understanding of the various example embodiments. It should be appreciated that various modifications to the embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the disclosure. Moreover, in the following description, numerous details are set forth for the purpose of explanation. However, one of ordinary skill in the art should understand that embodiments may be practiced without the use of these specific details. In other instances, well-known structures and processes are not shown or described in order to avoid obscuring the description with unnecessary detail. Thus, the present disclosure is not intended to be limited to the embodiments shown but is instead to be accorded the widest scope consistent with the principles and features disclosed herein. Hence, these and other changes can be made to the embodiments in light of the above-detailed description. In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the disclosure.

Claims

1 . An articulable surgical instrument, comprising: a first handle portion; a second therapy delivery portion; and a knuckle collar articulably coupling the first handle portion to the second therapy delivery portion across a lockable ball joint.

2. The articulable surgical instrument of claim 1 wherein the first handle portion includes a surgical table anchor.

3. The articulable surgical instrument of claim 1 wherein at least one of the first handle portion and the second therapy delivery portion is formed from aluminum.

4. The articulable surgical instrument of claim 1 wherein at least one of the first handle portion and the second therapy delivery portion is formed from a metal.

5. The articulable surgical instrument of claim 1 wherein at least one of the first handle portion and the second therapy delivery portion is formed from an alloy including at least one of aluminum, steel, platinum, chromium, and copper.

6. The articulable surgical instrument of claim 1 wherein at least one of the first handle portion and the second therapy delivery portion is formed from a light transmissive material.

7. The articulable surgical instrument of claim 1 wherein at least one of the first handle portion and the second therapy delivery portion is arranged for at least one of a pelvic surgical procedure, a vaginal surgical procedure, an anal surgical procedure, a gastric surgical procedure, a cranial surgical procedure, and an orthopedic surgical procedure.

8. The articulable surgical instrument of claim 1 wherein the second therapy delivery portion includes at least one channel arranged to pass at least one medical device.

9. The articulable surgical instrument of claim 1 wherein the lockable ball joint includes a first ball portion arranged to cooperate with one end of one of the first handle portion and the second therapy delivery portion, and wherein the lockable ball joint further includes a second ball portion arranged to cooperate with another end of the other of the first handle portion and the second therapy delivery portion.

10. The articulable surgical instrument of claim 1 wherein the lockable ball joint includes an unattached spherical or semi-spherical structure positionable between the first handle portion and the second therapy delivery portion, said spherical or semi-spherical structure being held in place by the knuckle collar.

11. A method of forming an articulable surgical instrument, comprising: providing a first handle portion having an elongated handle body with a proximal end and a distal end; providing a second therapy delivery portion having an elongated therapy delivery body; arranging a knuckle collar over a cooperating ball portion of a lockable ball joint; affixing a stem of the cooperating ball portion to one of the distal end of the elongated handle body and the proximal end of the elongated therapy delivery body; and removably coupling the knuckle collar to the other one of the distal end of the elongated handle body and the proximal end of the elongated therapy delivery body.

12. The method of claim 11 wherein at least one of the first handle portion and the second therapy deliver portion is formed of a plastic.

13. The method of claim 11 wherein at least one of the first handle portion and the second therapy deliver portion is arranged for sterilization.

14. The method of claim 11 wherein at least one of the first handle portion and the second therapy deliver portion is disposable.

15. The method of claim 11 , wherein knuckle collar and at least one of the first handle portion and the second therapy deliver portion are formed from a same material.

16. A lockable ball joint for a surgical instrument, comprising: a stem arranged for attachment to a distal end of a first medical device portion; a ball-like portion affixed to the stem, the ball-like portion having a lower spherical portion at which the stem is affixed and an upper spherical portion arranged to cooperate with a proximal end of a second medical device portion; and a generally cylindrical knuckle collar having a proximal end and a distal end, the proximal end of the generally cylindrical knuckle collar having an inside diameter X, and the distal end of the generally cylindrical knuckle collar having an inside diameter Y, wherein X is less than Y, wherein X is less than a diameter of the ball-like portion, wherein X is greater than a cross-sectional dimension of the stem, and wherein Y is greater than a diameter of the ball-like portion, wherein a thread structure is formed inside the generally cylindrical knuckle collar, the thread pattern arranged to receive a cooperative thread structure integrated in the proximal end of the second medical device portion, wherein the proximal end of the generally cylindrical knuckle collar has a first inside taper arranged to cooperate with the lower spherical portion of the ball-like portion, wherein the proximal end of the generally cylindrical knuckle collar has a second outside taper arranged to cooperate with a mating surface of the distal end of a first medical device portion, and wherein the distal end of the generally cylindrical knuckle collar is arranged to receive the proximal end of the second medical device portion in such a manner that prior to tightening the generally cylindrical knuckle collar, the first and second medical device portions are permitted to rotate with respect to each other and further permitted to articulate with respect to each other, and that after tightening the generally cylindrical knuckle collar, the first and second medical device portions are temporarily fixed in a selected relationship to each other.

17. The lockable ball joint for the surgical instrument of claim 16 wherein the generally cylindrical knuckle collar is hand tightened.

18. The lockable ball joint for the surgical instrument of claim 16 wherein the second medical device portion is arranged with a semispherical hollow arranged to cooperate with the upper spherical portion of the ball-like portion after the generally cylindrical knuckle collar is tightened.

19. The lockable ball joint for the surgical instrument of claim 16 wherein the generally cylindrical knuckle collar is formed from a metal or an alloy that includes at least one of aluminum, platinum, gold, chromium, copper, and steel.

20. The lockable ball joint for the surgical instrument of claim 16 wherein the generally cylindrical knuckle collar is formed from a composite material.