Patent Grant
8608652
The embodiments relate, in general, to medical procedures and devices to enter into a patient's body cavity and, more particularly, to devices for establishing at least one conduit into a patient's body cavity through a patient's orifice, such as a patient's vagina, to accomplish various surgical and therapeutic procedures.
Access to the abdominal cavity may, from time to time, be required for diagnostic and therapeutic endeavors for a variety of medical and surgical diseases. Historically, abdominal access has required a formal laparotomy to provide adequate exposure. Such procedures, which require incisions to be made in the abdomen, are not particularly well-suited for patients that may have extensive abdominal scarring from previous procedures, those persons who are morbidly obese, those individuals with abdominal wall infection, and those patients with diminished abdominal wall integrity, such as patients with burns and skin grafting. Other patients simply do not want to have a scar if it can be avoided.
Minimally invasive procedures are desirable because such procedures can reduce pain and provide relatively quick recovery times as compared with conventional open medical procedures. Many minimally invasive procedures are performed with an endoscope (including, without limitation, laparoscopes). Such procedures permit a physician to position, manipulate, and view medical instruments and accessories inside the patient through a small access opening in the patient's body. Laparoscopy is a term used to describe such an “endosurgical” approach using an endoscope (often a rigid laparoscope). In this type of procedure, accessory devices are often inserted into a patient through trocars placed through the body wall. Trocars must typically pass through several layers of overlapping tissue/muscle before reaching the abdominal cavity.
Still less invasive treatments include those that are performed through insertion of an endoscope through a natural body orifice to a treatment region. Examples of this approach include, but are not limited to, cholecystectomy, appendectomy, cystoscopy, hysteroscopy, esophagogastroduodenoscopy, and colonoscopy. Many of these procedures employ the use of a flexible endoscope during the procedure. Flexible endoscopes often have a flexible, steerable articulating section near the distal end that can be controlled by the user by utilizing controls at the proximal end. Minimally invasive therapeutic procedures to treat diseased tissue by introducing medical instruments to a tissue treatment region through a natural opening of the patient are known as Natural Orifice Translumenal Endoscopic Surgery (NOTES)™. Entry through a natural opening, such as a patient's vagina, for example may further reduce the pain a patient experiences after the procedure because the vaginal walls have less pain receptors than do the abdominal walls.
Some flexible endoscopes are relatively small (about 1 mm to 3 mm in diameter), and may have no integral accessory channel (also called biopsy channels or working channels). Other flexible endoscopes, including gastroscopes and colonoscopes, have integral working channels having a diameter of about 2.0 mm to 3.5 mm for the purpose of introducing and removing medical devices and other accessory devices to perform diagnosis or therapy within the patient. As a result, the accessory devices used by a physician can be limited in size by the diameter of the accessory channel of the scope used. Additionally, the physician may be limited to a single accessory device when using the standard endoscope having one working channel.
Certain specialized endoscopes are available, such as large working channel endoscopes having a working channel of about 5-10 mm in diameter, which can be used to pass relatively large accessories, or to provide capability to suction large blood clots. Other specialized endoscopes include those having two or more working channels. Regardless, using an endoscope alone to perform a surgical procedure may be limiting in that multiple tools may not be easily moved apart from one another to perform a surgical procedure.
The above mentioned minimally invasive surgical procedures have changed some of the major open surgical procedures such as gall bladder removal, or a cholecystectomy, to simple outpatient surgery. Consequently, the patient's return to normal activity has changed from weeks to days. These types of surgeries are often used for repairing defects or for the removal of diseased tissue or organs from areas of the body such as the abdominal cavity.
The foregoing discussion is intended only to illustrate the present field and should not be taken as a disavowal of claim scope.
In various embodiments, a surgical method is provided for introducing a conduit into a patient's body cavity. In at least one embodiment, the method can comprise inserting a speculum into a patient's vagina, the speculum including two or more blades movable with respect to each other, expanding the speculum by moving the blades apart from each other such that the blades move apart walls of the vagina, obtaining a surgical delivery device coupled to a transorifice device, the transorifice device including a flexible conduit, inserting a portion of the surgical delivery device through the speculum such that a portion of the transorifice device is also inserted through the speculum, creating an incision in the vagina, passing a tip of the surgical delivery device through the incision and into a body cavity of the patient, and releasing the transorifice device from the surgical delivery device such that a distal portion of the flexible conduit is located within the body cavity.
In various embodiments, a speculum is provided. In at least one embodiment, the speculum can comprise a base defining an opening therethrough, a first blade attached to the base, a second blade attached to the base, and at least one locking assembly configured to releasably hold the first blade and the second blade relative to each other in at least one locked position. In these embodiments, the base can comprise a proximal surface, the first blade can comprise a first distal end, and the second blade can comprise a second distal end. Further, in these embodiments, the first blade and the second blade are movable with respect to each other. Moreover, in these embodiments, when the first blade and the second blade are in the at least one locked position, the shortest distance between the first distal end and a plane defined by the proximal surface is substantially equal to the shortest distance between the second distal end and the plane defined by the proximal surface.
In various embodiments, a transorifice device is provided. In at least one embodiment, the transorifice device can comprise a port assembly defining at least one port therein and a flexible conduit extending from the distal side of the port assembly. In these embodiments, the port assembly can include a proximal side and a distal side. Further, in these embodiments, the flexible conduit can include a proximal portion adjacent to the port assembly and a distal portion. Moreover, in these embodiments, the flexible conduit can further comprise a pliable ring located at the distal portion.
In various embodiments, a surgical delivery device is provided. In at least one embodiment, the surgical delivery device can comprise a body including a proximal end and a distal end, a tip movably mounted to the distal end of the body such that the tip can move between an opened position and a closed position, and a balloon surrounding at least part of the body and located adjacent the distal end of the body. In these embodiments, the body can define a tool receiving passageway therein including a proximal opening located at the proximal end and a distal opening located at the distal end.
The novel features of the embodiments described herein are set forth with particularity in the appended claims. The embodiments, however, both as to organization and methods of operation may be better understood by reference to the following description, taken in conjunction with the accompanying drawings as follows.
Certain embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments and that the scope of these embodiments is defined solely by the claims. The features illustrated or described in connection with one embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the appended claims.
In the following description, like reference characters designate like or corresponding parts throughout the several views. Also in the following description, it is to be understood that terms such as “forward,” “rearward,” “front,” “back,” “right,” “left,” “upwardly,” “downwardly,” “proximally,” “distally,” and the like are words of convenience and are not to be construed as limiting terms. The description below is for the purpose of describing various embodiments and is not intended to limit the appended claims.
The various embodiments generally relate to various devices, kits, and/or systems for use in connection with endoscopes, including laparoscopes, for performing a surgical procedure or procedures within a patient's body cavity. The terms “endoscopic tools” and “endoscopic surgical instruments” as used herein may comprise, for example, endoscopes, lights, insufflation devices, cleaning devices, suction devices, hole-forming devices, imaging devices, cameras, graspers, clip appliers, loops, Radio Frequency (RF) ablation devices, harmonic ablation devices, scissors, knives, suturing devices, etc. However, such terms are not limited to those specific devices. As the present Description proceeds, those of ordinary skill in the art will appreciate that the unique and novel features of the various instruments and methods for use thereof may be effectively employed to perform surgical procedures by inserting such endoscopic tools through a natural body lumen (e.g., the mouth, anus, and/or vagina) or through a transcutaneous port (e.g., a abdominal trocar, and/or cardiothoracic port) to perform surgical procedures within a body cavity.
The various embodiments described herein are directed to medical devices and, more particularly, to methods and devices which can be useful in minimally invasive endoscopic procedures carried out with an endoscope and/or a similar surgical instrument. Further, the various embodiments can include devices, systems, and/or methods useful in natural orifice translumenal endoscopic surgery (“NOTES”) procedures. As noted above, NOTES procedures may be performed transorally, transgastrically, and/or transvaginally. In at least one such embodiment, and referring to
Briefly, the speculum 100 may be inserted into and serves to enlarge or dilate a patient's orifice, such as a female patient's vagina. The surgical delivery device 200 may perform several functions, such as applying and/or dilating an incision (an otomy) to a tissue wall of the patient and/or assisting in the proper placement and/or sealing of the transorifice device 300 within a body cavity, such as the patient's abdominal cavity. The transorifice device 300, once properly in position, as described below, may provide a flexible conduit from outside the patient, through the patient's orifice, and into the body cavity. Further, the transorifice device 300 may provide multiple tool ports therethrough, enabling multiple surgical instruments to be placed through a single orifice and be positioned independently of one another. Accordingly, a system may be provided that provides for the rapid creation of multiple ports in a natural orifice, such as a patient's vagina, while accommodating anatomical variation to reduce the need to excise additional tissue from the patient.
Further, in at least one embodiment, referring to
Focusing now on at least one non-limiting embodiment, a NOTES system is provided for vaginal entry. Referring to
Further, the speculum 100 may comprise at least two blades, a first blade 120 attached to the base 110 and a second blade 130 also attached to the base 110. Referring to
Referring to
Additionally, the speculum may comprise at least one locking assembly configured to releasably hold the first blade and the second blade relative to each other in at least one locked position. Referring to FIGS. 1 and 5A-5B, in one exemplary embodiment, the locking assemblies may comprise a first ratchet assembly 150 operably engaged with the first blade 120, a second ratchet assembly 160 operably engaged with the second blade 130, and a third ratchet assembly 170 operably engaged with the third blade 140.
In more detail, referring to
Still referring to
Each pawl of ratchet assemblies 160, 170 may be disengaged from the second angled teeth and/or third angled teeth 172 by pushing, pulling, twisting, and/or otherwise operating a second button 161 and/or third button 171 which are each operably coupled to their respective pawls. Accordingly, when a user operates the second button 161, the second ratchet assembly 160 may allow the second blade 130 to move freely toward the first blade 120 and/or third blade 140. Likewise, when a user operates the third button 171, the third ratchet assembly 170 may allow the third blade 140 to move freely toward the first blade 120 and/or second blade 130. In various embodiments, the buttons 161, 171 may each be locked into an open position such that each one's associated pawl is disengaged from teeth 162, 172 temporarily even if a user removes his or her finger(s) from the button 161 and/or 171. In such embodiments, the blades 130 and/or 140 may then be moved freely to a desired position, after which the button may be unlocked to a closed position such that the respective pawl reengages the teeth 162 or 172 and resists movement of the blade 130 and/or 140, as described above. Also, in various embodiments, although not illustrated, the pawl of each ratchet assembly 150, 160, 170 may be contained within each assembly 150, 160, 170, through which a portion of support bar 122, 132, 142 and thus teeth 152, 162, 172 may pass to engage each pawl, respectively.
Thus, in the illustrated embodiment of
According to at least one embodiment, a vaginal speculum may be inserted into a patient's vagina and expanded to create access to a desired incision, or otomy, site. By way of example and referring to FIGS. 5A and 6A-6B, speculum 100 may be first closed to an entry position by moving the blades 120, 130, 140 close together, see
Referring now to
Next, referring to
Notably, the first, second, and/or third blades, 120, 130, 140 may be moved with respect to each other without a handle. As used herein, a handle includes a part made specifically to be grasped or held by the hand. In traditional speculums, the blades are typically operated by manipulating at least one handle that is grasped by a user. However, various embodiments herein do not require a handle and thus maximize the working area available around the speculum 100 such that additional instruments, such as a surgical delivery device 200 (
Still referring to
Further, as noted above, owing to the uniform length of each blade 120, 130, 140, the depth that each blade's distal end 121, 131, 141 (see
Additionally, as will become evident from the disclosure which follows below, the proximal surface 112 of the base 110 may serve as a support surface for at least one additional surgical device of a surgical system, for example, for a transorifice device 300 (see
Referring to
In various embodiments, referring to
Further, in various embodiments, the body 210 may be rigid. For example, in at least one such embodiment, the rigid body 210 may be made, at least partially, from aluminum or any other suitable metal or other rigid material. Additionally, such a rigid body 210 may define at least one curve corresponding to the passageway 211. For instance, referring to
Referring back to
The tip 220 may be mounted to the distal end 213 of the body 210 in various ways. For example, referring to
Other configurations are possible to allow an endoscope or other surgical tool to protrude through a surgical delivery device. By way of example, in at least one embodiment, a tip of a surgical delivery device may comprise at least one cantilevered arm (not shown). For instance, the tip may include multiple cantilevered arms that are attached to the distal end of the delivery device's body. The cantilevered arms may be biased towards each other to form a closed configuration. Then arms may come together at the distal most point, or the apex, of the tip in a petal-like arrangement. Pressing a distal end of an endoscope against the arms may allow the cantilevered arms to bend away from each other to an opened position and the endoscope to advance beyond the tip. Pulling the endoscope back into the passageway of the surgical delivery device may permit the cantilevered arms to move back towards each other to a closed position. A person skilled in the art will appreciate that the tip can have a variety of configurations to facilitate its opening and closing.
In various embodiments, referring to
In various embodiments, a tip of a surgical delivery device, such as tip 220 may be configured to incise tissue. For example, referring to
Accordingly, in various embodiments and referring to
Referring now to
As illustrated in
The surgical delivery device 200 may perform a number of functions. For example, as discussed above, the delivery device 200 may deliver an incision to an otomy site, the delivery device 200 may conceal, guide, be guided by, and/or deliver a surgical tool (e.g., an endoscope) to a body cavity, and/or the delivery device 200 may dilate an incision or other opening in the patient's body. Additionally, in various embodiments, the surgical delivery device may also serve to assist in the proper placement and/or sealing of a transorifice device 300 within a body cavity.
By way of example and referring to
Moving now to the details regarding a transorifice device, such as transorifice device 300, referring to
Briefly, and as will be explained in more detail below, the transorifice device may be configured to span an orifice of a patient to create a conduit from outside the patient to inside the patient's body. For example, the transorifice device may be used in a vaginal NOTES procedure. Referring now to
Referring back to
Referring still to
Further, in at least one embodiment, each of the ports 311, 312, 313 may be independently removed from the port assembly 310. Alternatively, and as explained in more detail below, the ports 311, 312, 313 may be collectively removed from the port assembly 310. Further, the port portion or cap supporting the ports 311, 312, 313 may also be removed to additionally increase the diameter of an opening through which an item may passed. The port portion or cap may include the proximal surface 314 seen in
Focusing now on the flexible conduit 320, in various embodiments, referring to
Accordingly, in various embodiments, referring to
In more detail, the pliable ring 323 may be constructed as follows. The flexible membrane of the conduit 320 may include a multi-lumen channel therein that allows a nitinol wire, for example, to be wrapped multiple times around the conduit 320, thereby avoiding needing to connect one end of the wire to another, which may prevent problems due to bending of the wire at that point during use. In at least one exemplary embodiment, the pliable ring may be approximately 0.089″ in cross-sectional diameter. Further, the flexible membrane of the conduit 320 may include three lumens, with each lumen being approximately 0.024″ in diameter, and a nitinol wire, which may be approximately 0.019″ or 0.021″ in diameter. As one will appreciate, using thicker wire may provide a stiffer ring and thinner wire may provide a less stiff ring. In any event, the wire may make two complete loops around the conduit 320 which may include a wall of approximately 0.008″ in thickness. Further, the lumens may be have an inner diameter of approximately 0.090″ and may be approximately ⅝″ to approximately ¾″ long to cover the ring once formed in the conduit 320. In a working test, ring inner diameters in the range of about 2⅛″ to about 2¾″ were made and used in prototypes. A benchtop test showed that the 2⅛″ and 2⅝″ rings have relative pull through forces of 9 and 16 lbs respectively. Accordingly, as the ring should be able to completely pass through a vagotomy to be placed inside a patient's body cavity, a shorter ring may have an advantage.
In at least one embodiment, referring now to
Notably, the port assembly 310 and the flexible conduit 320 may be configured to receive a surgical tool therethrough. Specifically, regarding positioning the transorifice device 300 at least partially within a patient, in at least one embodiment and referring to
Thus, in at least one embodiment, and as noted above, referring to
After a surgical procedure is completed, the transorifice device may be removed by pulling the port assembly 310 away from the patient, thereby forcing the pliable ring 323 to bend and fit through incision 14. Alternatively, the suture 324 may continue in a proximal direction at least to the port assembly such that a user may pull on the suture to collapse or buckle the pliable ring 323 to fit it through the incision prior to pulling on the port assembly 310. Further, a tie off structure such as a protrusion may be part of the port assembly 310 to hold the suture 324 at that position until needed.
Focusing now on the support member 330, in various embodiments, the support member 330 may be configured to provide support for the port assembly 310 and/or the flexible conduit 320 after the transorifice device 300 is positioned at least partially within a speculum, such as speculum 100, see
Still referring to
Further, in at least one embodiment and as seen in
In at least one embodiment, the expandable bladder 332 may be connected to the port assembly 310 and the flexible conduit may pass through the expandable bladder 332. Alternatively, the bladder 332 may be discontinuous with the port assembly 310; however, the flexible conduit 320 may still pass through the expandable bladder. In such embodiments, the bladder 332 may also be movable with respect to the flexible conduit 320. Further, in at least one embodiment, the flexible conduit may be integrally formed with the bladder 332.
Further, referring to
The transorifice device 300 may be further configured to provide additional protection to tissue and/or organs within a patient's body during a surgical procedure. For example, in at least one embodiment, the transorifice device 300 may further comprise a first extendable sleeve 340 extending from at least one port, such as first port 311. The extendable sleeve 340 may be further located at least partially within the flexible conduit 320. Further, in another embodiment, the transorifice device 300 may further comprise a second extendable sleeve 350 extending from the second port 312. The second extendable sleeve 350 may further be located at least partially within the flexible conduit 320. As shown in
In at least one embodiment, referring to
In various embodiments, one or more of the extendable sleeves 340, 350 may include features to facilitate their extension. For example, referring to
In at least one embodiment, the extendable sleeves 340, 350, may be extended as follows. Initially, the extendable sleeves 340, 350 may be received by a user in a retracted configuration, see
In at least one embodiment, an extendable sleeve may extend from each of the ports 311, 312, 313. Alternatively, and as illustrated in
By way of overview and with reference above as needed, and/or helpful, in various embodiments, referring to
Referring to
Next, referring to
Referring to
Further, in various embodiments, the body cavity 20 may be insufflated prior to, during, and/or after the insertion of surgical delivery device 200 into cavity 20. For example, referring to
Next, referring to
Referring to
Ultimately, a surgical procedure, such as an oophorectomy, cholecystectomy, and/or hepatectomy, for example, may be performed through the transorifice device 300. For example, an endoscope 500 may be inserted into a steerable flexible trocar 400 to provide additional control and stability to the endoscope 500. The endoscope 500 and steerable flexible trocar 400 may then be inserted into a port, port 313 for example, which may not have an extendable sleeve associated therewith. A sheath 460 of the flexible trocar 400, the endoscope's tube-like portion 502, and/or the endoscope's distal end 503 may then be at least partially advanced distally, through the flexible conduit 320 and into the body cavity 20. The flexible trocar's sheath 460 may be steered or otherwise articulated via a control handle 461 coupled to the sheath 460 by at least one control wire contained within control cable 463. Adjusting the handle 461 may move the control wires to articulate the sheath 460 and thereby position the endoscope's distal end 503 within the cavity 20. The surgical procedure may thus be visualized through the endoscope 500. Further, in at least one embodiment, the endoscope 500 may have working channels (not shown) for passing endoscopic tools therethrough.
Still referring to
After completing the surgical procedure, various components of the system may be removed from the patient as described above. Then, the incision 14 may be closed using one or more sutures and/or biocompatible adhesives or sealants as is known in the field.
In various embodiments, additional speculums and speculum features are envisioned which may, among other things, provide similar advantages to that described above with respect to speculum 100 and may also be substituted for speculum 100 in a surgical system, kit, and/or method such as that shown and portrayed in one or more of
Additionally, referring to
Additionally, while it may be desirable to attach different blade tip attachments to a speculum, it is also possible for each blade to have an integral blade tip portion that includes a shape which protrudes away from the other blade(s) without requiring a separate attachment as shown in
In any event, regardless of whether one or more blades have an integral blade tip portion or a blade tip attachment, each blade may vary in width length, thickness, contour, and distal shape to address anatomical variation between patients, to provide enhanced position holding or retention of the speculum at a desired location in the vagina, or to address exposure preferences when opening the speculum. By way of example and in at least one embodiment, referring to
Referring back to
Additionally, referring to
Continuing, referring to both
Referring to
Moving now to
In at least one embodiment, referring to
In various embodiments, a speculum may include additional and/or different locking assemblies to those described herein, e.g., the ratchet assemblies. By way of example, a locking assembly may comprise a latch or catch that may work in conjunction with a hinge to allow the speculum blades to move relative to one another and subsequently be locked into an open position. In particular,
Further, referring to
As noted above, referring to
Further, referring to
Further, one or both of speculum blades 3120, 3130 may respectively include a distal portion 3123, 3133 including a shape which is partially parabolic. In other words, the distal portions 3123, 3133 of blades 3120, 3130 may curve towards each other to ease insertion into a natural orifice, such as vagina 10, seen in
After closing the speculum 3100, as shown in
Also, as noted above, speculum 3100 may serve as a support structure for at least one other surgical device. Thus, the proximal surfaces 3112a, 3112b of the base portions 3110a, 3110b may collectively serve as support or contact surfaces for at least one additional surgical device of a surgical system, for example, for a transorifice device 300 (see
The hinged speculum 3100 shown in
Referring now to
However, when the blades 4120, 4130 of speculum 4100 are opened to the locked position shown in
Briefly, the speculum 4100 may be used as follows. The speculum 4100 may first be fully closed such that the blades 4120, 4130 mirror each other. Second, the speculum 4100 may then be inserted into a patient's vagina. Third, the speculum 4100 may be opened and the first and second blades 4120, 4130 locked via latch 4150 into the position shown in
After the surgical procedure is completed, the ratchet assembly 4160 may be unlocked by manipulating button 4161 and then the third blade 4140 may be moved away from the ratchet assembly, towards a closed position. Then, the ratchet assembly 4160 and blade 4140 can be detached from the base 4110 in reverse fashion to that with which they were attached thereto. Next, the finger tabs 4151a, 4151b may be pressed apart to release latch 4150 and unlock the speculum 4100 such that the first blade 4120 and the second blade 4140 may move towards each other into a closed position. Finally, the closed speculum 4100 may be removed from the patient.
Additionally, the blades 4120, 4130 of speculum may each comprise a distal portion 4123, 4133, respectively, which has an enlarged semi-spherical shape to assist with both insertion and gripping of the vaginal walls. Alternatively, as described above, the blades 4120, 4130 may have different shapes, including those disclosed herein. Further, while not shown, speculum blades according to various embodiments may include a roughened or textured surface to enhance gripping of the vaginal walls.
As noted above,
As discussed above, a speculum according to various embodiments may include additional and/or different locking assemblies to those described herein. By way of another example, a locking assembly may comprise a linkage or set of linkages to allow the speculum blades to move relative to one another and subsequently be locked into an open position. In particular, referring to
The attachment of the blades 5120, 5130 to the base 5110 may be described as follows. Note,
Additionally, the blades 5120, 5130 may also be movable with respect to each other to move between a closed position, as seen in
As with the other exemplary speculums described herein, the speculum 5100 may include one or more locking assemblies, such as first and second linkage assemblies 5150, 5160, that are configured to releasably hold the first blade 5120 and the second blade 5130 relative to each other in at least one locked position. Referring to
Further, still referring to
Moving now to the other side of speculum 5100, second linkage assembly 5160 may be similar to and/or mirror the first linkage assembly 5150 about base 5110. Accordingly, the second linkage assembly 5160 may comprise a second locking lever 5161 pivotally coupled to the first blade via support bar 5122 and a second link 5162 pivotally coupled to the second blade 5130 via support bar 5132. The second locking lever 5161 may also be pivotally coupled to the first link 5152. In more detail, and as with first linkage assembly 5150, the locking lever 5161 may include a finger operable portion 5161a that is configured to be pushed and/or pulled by a user to move the linkage assembly 5160, and, subsequently, to also move the second blade 5130 relative to the first blade 5120. Also, the locking lever 5161 may include a link portion 5161b integrally formed with or fixedly attached to the finger operable portion 5161a. The link portion 5161b may pivotally connect to both the first support bar 5122 and the second link 5162 at or near the ends of link portion 5161b. Likewise, the second link 5162 may be pivotally connected to both the link portion 5161b and the second support bar 5132 at or near the ends of second link 5162.
The first and second linkage assemblies 5150, 5160 and the first and second blades 5120, 5130, thus form a six-bar linkage, that, when the locking levers 5151, 5161, are pulled out, away from base 5110 via finger operable portions 5151a, 5151b, will move the blades 5120, 5130 toward each other, see, e.g.,
The first and second linkage assemblies 5150, 5160 may be operated independently or in unison to move second blade 5130 relative to first blade 5120. It will be readily appreciated that, due to the linkage assemblies 5150, 5160, the second blade 5130 may be moved directly away or towards the first blade 5120 by operating both levers 5151, 5161 at the same time, see, e.g.,
Additionally, speculum 5100 may provide various additional advantages. For example, when the blades 5120, 5130 are in a locked position, the shortest distance between the first distal end 5121 and a plane defined by the proximal surface 5112 may be substantially equal to the shortest distance between the second distal end 5131 and the plane defined by the proximal surface 5112. Accordingly, the working distance from the proximal surface 5112, which, again, may serve as a support surface for another surgical instrument, to an otomy site located between the blades 5120, 5130 may be known, thereby helping remove anatomical variation between patients as a significant surgical factor.
As will be appreciated from the disclosure above,
In more detail, and similar to other speculums described herein, such as speculum 5100, speculum 6100 can comprise base 6110 defining an opening 6111 therethrough, e.g., inner wall 6113 of base 6110 may define the opening 6111, and the base 6110 can also comprise a proximal surface 6112 which, similar to that discussed above at least with respect to speculum 100, may serve as a support surface for another surgical device. Further, speculum 6100 may comprise first blade 6120 attached to the base 6110 and blade 6120 may include a first distal end 6121. Speculum 6100 may additionally comprise a second blade 6130 attached to the base 6110 and blade 6130 may also comprise a second distal end 6131. As described above, the blades 6120, 6130, may comprise distal portions 6123, 6133, respectively that have a shape that is at least partially parabolic.
The blades 6120, 6130 may be attached to the base 6110 as follows. Each blade 6120, 6130 may extend from a support bar 6122, 6132 fixedly attached thereto or formed therewith. Further, the support bars 6122, 6132 may be configured to fit, slide, and/or be received within a groove 6115 defined within base 6110. The support bars 6122, 6132 may cooperate with linkage assemblies 6150, 6160, portions of which may also be received within groove 6115, to attach blades 5120, 5130 to base 5110.
As with the other exemplary speculums described herein, such as speculum 5100, for example, the speculum 6100 may include one or more locking assemblies, such as first and second linkage assemblies 6150, 6160, that are configured to releasably hold the first blade 6120 and the second blade 6130 relative to each other in at least one locked position. Referring to
Further, still referring to
Moving now to the other side of speculum 6100, second linkage assembly 6160 may be similar to the first linkage assembly 6150. Accordingly, the second linkage assembly 6160 may comprise a third link 6161 pivotally coupled to the first blade 6120 via support bar 6122 and a fourth link 6162 pivotally coupled to the second blade 6130 via support bar 6132. The third link 6161 may also be pivotally coupled to the fourth link 6162. In more detail, the third link 6161 may pivotally connect to both the first support bar 6122 and the fourth link 6162 at or near the ends of link 6161. Likewise, the fourth link 6162 may be pivotally connected to both the third link 6161 and the second support bar 6132 at or near the ends of link 6162. Additionally, similar to that described with respect to first linkage assembly 6150, to maintain a central positioning of blades 6120, 6130 in relation to opening 6111 and to provide a pair of fulcrum points against which the second linkage assembly 6160 may be leveraged, the linkage assembly 6160 may further comprise a pair of pins 6165a, 6165b. Pin 6165a may be disposed in an arced channel 6163 formed in link 6161 and pin 6165b may be disposed in an arced channel 6164 formed in link 6162. The pins 6165a and 6165b may be further sized and configured to slide in at least one slot 6116 formed in base 6110 within groove 6115. Accordingly, movement of either or both of links 6161, 6162 is controlled such that a portion of each arced channel 6163, 6164 remains within groove 6115 of base 6110.
Similar to that described above with respect to speculum 5100, the first and second linkage assemblies 6150, 6160 and the first and second blades 6120, 6130 of speculum 6100, thus form a six-bar linkage, that, when the one or both sets of links 6151, 6152 and 6161, 6162 are pulled or pushed out, away from base 6110, will move the blades 6120, 6130 toward each other, see, e.g.,
Similar to that described above with respect to link speculum 5100, the first and second linkage assemblies 6150, 6160 of speculum 6100 may be operated independently or in unison to move the first and/or second blade 5130 relative each other. It will be readily appreciated that, due to the linkage assemblies 6150, 6160, the second blades 6120, 6130 may be moved directly away or towards each other by operating both linkage assemblies 6150, 6160 at the same time, see, e.g.,
Additionally, speculum 6100 may provide various additional advantages. For example, when the blades 6120, 6130 are in a locked position, the shortest distance between the first distal end 6121 and a plane defined by the proximal surface 6112 may be substantially equal to the shortest distance between the second distal end 6131 and the plane defined by the proximal surface 6112. Accordingly, the working distance from the proximal surface 6112, which, again, may serve as a support surface for another surgical instrument, to an otomy site located between the blades 6120, 6130 may be known, thereby helping remove anatomical variation between patients as a significant surgical factor.
As noted above, the features illustrated or described in connection with one embodiment may be combined with the features of other embodiments. By way of non-limiting example, and referring now to
The various speculum embodiments described herein may include various materials for the speculum components. For example, the various parts of the speculum may be made from a clear plastic to allow visualization of the patient's tissues. Further, the materials may be made of any color to help indicate various portions which are to be operated by a user. Additionally, the materials may be disposable after use. Such disposable materials may include polycarbonate. However, the materials may be re-sterilized after use. Such re-sterilizable materials may include polysulfone. Further, the materials may also be one or more metals, such as stainless steel, aluminum, magnesium, and titanium, for example. Various combinations of materials, such as those outlined above, are also possible. For example, the base may be made from a plastic, while the blades are made from a metal.
Further, additional modifications and/or uses of the speculums described herein are encompassed by various embodiments. By way of a first, non-limiting example, a light port may be added to at least one of the speculum blades to disperse light. In such embodiments, the light dispersing blade(s) may be made from a clear polycarbonate and an independent light source may be coupled to the blade(s) to cause light to travel through the blade and radiate light or glow, thereby providing enhanced lighting of the vagina and/or the otomy site therein, for example. Alternatively, a light tube, e.g., a fiber optic cable, may be added to one or more of the speculum blades to enable light to be fed to a distal portion of the blade. Light of any frequency may be provided. In at least one embodiment, the light frequency may be tuned or chosen to provide enhanced viewing of the tissue, e.g., the vaginal walls. Further, to better enable a user to see through a distal portion of at least one of the blades, one or more blades may include a video camera lens which may provide a signal to an external monitor, for example.
By way of a second, non-limiting example, a suction, a pressure, and/or an irrigation port may be added to one or more of the speculum blades. Such a port may be incorporated into the blade shape itself or independent tubing may run through the blade. Further, the port may be a carbon dioxide port which may assist with insufflation.
By way of a third, non-limiting example; a speculum may be configured for use through a body wall, such as the abdominal wall, and not through a natural orifice. In such embodiments, the speculum may function to help dilate an incision to increase the working area therethrough. In at least one embodiment, one or more of the distal ends of the speculum blades may form a sharp point. Further, all of the distal ends of the speculum blades may forma sharp point, that, when the speculum is in a closed configuration, cooperate together to form an incising point. The incising point may be applied to a patient's body wall, e.g., the abdominal wall, to incise the wall and pass the blades therethrough. Then, the speculum blades may be opened, thereby dilating the incision. In at least one embodiment, the speculum base and/or locking assembly/assemblies may be advanced until at least one of them contacts the exterior of the patient. Thereafter, a plug, such as the transorifice device described above, may be added to permit a sealed, port-based surgical procedure to be completed utilizing endoscopic, including laparoscopic, tools, for example. In such embodiments, a port, such as the suction, pressure, and/or irrigation port mentioned above, may be used to perform additional functions through the speculum (e.g., insufflation) without requiring additional incisions beyond that needed to introduce the speculum through the body wall.
By way of a fourth, non-limiting example, one or more speculum blades may include a conduit that forms a channel other delivery mechanism for providing various energy or signals to and/or from the blades. For instance, the blades may include an energy delivery mechanism for producing radio frequency energy, for example, to assist with coagulation. Additionally, ultrasound and/or laser energy may also be produced from a portion, e.g., a distal portion, of the speculum blade(s). Further, imaging modalities, such as static pictures, or dynamic videos may be recorded at or through the blades and passed to an external recording media. In any event, such energy and/or signal transmission may be passed through wires embedded in or pass along a surface of one or more of the speculum blades.
By way of a fifth, non-limiting example, in embodiments including a port or other conduit, such as those described above, a manifold may be incorporated into the speculum, near the base, for example, to allow multiple inputs and/or outputs. The outputs may be connected to an extension, either rigid or flexible, that allows one to continue to perform the functions of the manifold, such as irrigation, suction, and/or energy deliver, for example.
By way of a sixth, non-limiting example, one or more sensors may be incorporated into one or more of the speculum blades. Such sensors may provide various types of feedback, including, but not limited to, their position relative to one another or their depth in a patient's body, temperature, moisture, heart rate, blood pressure, and the like. Any such sensor(s) may also provide anatomical and/or calibration reference indicators for a user.
By way of a seventh, non-limiting example, one or more of the speculum blades may be configured to deliver a drug. In such embodiments, the blade(s) may provide a port or conduit through which a needle, or extendable needle, may pass through to allow direct injection into a patient's body, through the speculum blade(s).
In various embodiments, additional surgical delivery devices and related surgical delivery device features are envisioned which may, among other things, provide similar advantages to that described above with respect to surgical delivery device 200 and may also be substituted for surgical delivery device 200 in a surgical system, kit, and/or method such as that shown and portrayed in one or more of
In more detail regarding the curved shape of a surgical delivery device, in various embodiments, referring now to
Focusing now on tip 1220 and
As explained above with respect to delivery device 200, the tip 1220 may be mounted to the distal end 1213 of the body 1210 in various ways. For example, referring to
Also as noted above with respect to surgical delivery device 200, referring now to
Further, also similar to that described with respect to surgical delivery device 200, the tip 1220 of delivery device 1200 may be configured to incise tissue. For example, referring to
Again, similar to that discussed above with respect to surgical delivery device 200, the surgical delivery device 1200 may be configured to dilate an incision by expanding a balloon 1230 that surrounds at least part of the body 1210 and that may be located adjacent the distal end 1212 of the body 1210. The balloon 1230 is shown in an unexpanded and/or deflated configuration in
Similar to balloon 230 described above with respect to surgical delivery device 200, as illustrated in FIGS. 21 and 22B-22C, the balloon 1230, when expanded, may have a shape with outward sides that are linear, as viewed from the side. In other words, the balloon 1230 may have a uniform, straight shape in a proximal-to-distal (or vice-versa) direction. However, as explained above, various configurations are possible for the balloon 1230 to expand and dilate tissue at an incision or other opening into a patient's body and/or body cavity.
In various embodiments, as with surgical delivery device 200, the surgical delivery device 1200 may also serve to assist in the proper placement and/or sealing of a transorifice device, such as transorifice device 1300 within a body cavity. For example and referring to
In various embodiments, additional transorifice devices and related transorifice device features are envisioned which may, among other things, accomplish similar advantages to that described above with respect to transorifice device 300 and may also be substituted for transorifice device 300 in a surgical system, kit, and/or method such as that shown and portrayed in one or more of
Transorifice device 1300 may be similar to transorifice device 300. For instance, referring to
Referring briefly to
Notably, in at least one embodiment and referring to
Similar to that described above with respect to transorifice device 300, referring to
Further, similar to transorifice device 300, the flexible conduit 1320 may also comprise a flexible, resilient, or pliable ring 1323 located at the distal portion 1322 of the conduit 1320. Additionally, the flexible conduit 1320 may also comprise a suture 1324 connected to the pliable ring 1323 and/or to the distal portion 1322 of the conduit 1320. The pliable ring 1323 may be configured such that when it is not under external force, the ring 1323 assumes the shape shown in
However, in at least one embodiment referring now to
Focusing now on the support member 1330, in various embodiments, the support member 1330 may be configured to provide support for the port assembly 1310 and/or the flexible conduit 1320 after the transorifice device 1300 is positioned at least partially within a speculum, such as speculum 2100, see
Referring to
Further, similar to transorifice device 300, in at least one embodiment and as seen in
Further, referring still to
In at least one embodiment, referring to
The transorifice device 1300 may be further configured to provide additional protection to tissue and/or organs within a patient's body during a surgical procedure. For example, in at least one embodiment, the transorifice device 1300 may further comprise a first extendable sleeve 1340 extending from first port 1311. The extendable sleeve 1340 may be further located at least partially within the flexible conduit 1320, when the port portion 1310a is connected to the conduit portion 1310b. Further, in another embodiment, the transorifice device 1300 may further comprise a second extendable sleeve 1350 extending from the second port 1312. The second extendable sleeve 1350 may further be located at least partially within the flexible conduit 1320, when the port assembly portions 1310a, 1310b are connected to each other. As shown in
Further, in at least one embodiment, referring to
Similar to transorifice device 300, described above, in various embodiments, one or more of the extendable sleeves 1340, 1350 may include features to facilitate their extension. For example, referring to
Varying options are discussed above to allow a user to extend the extendable sleeves of a transorifice device. However, additional options are possible to achieve the same or similar result. For example, in at least one embodiment and referring to
Another exemplary embodiment of a transorifice device 4300 including a sleeve 4340 is shown in
Further, referring still to
Additionally, the seal assembly 4345 may further comprise at least one seal. In at least one embodiment, the seal assembly 4345 may further comprise a first seal 4346a and a second seal 4346b. The first seal 4346a may be a duckbill seal and the second seal 4346b may be a lip seal, or vice versa. A duckbill seal may help maintain pressure for insufflation, while the lip seal may accommodate varying sizes of surgical tools while keeping an edge of the seal flush with a surface of a surgical tool for sterility maintenance, for example.
The seal or seals mentioned herein in respect to any of the surgical system components, such as a transorifice device, may be substituted for various other seals known in the field. For example, each seal may include one or more of the following: a duckbill seal; a lip seal, an S-shaped seal, a foam seal, a gel seal, and a pierceable membrane. Alternatively, the seal(s) may be omitted entirely from the devices described herein.
Various embodiments are also envisioned for a support member associated with a transorifice device. For example, a support member may comprise an expandable bladder 332 or 1332, as describe above with respect to transorifice devices 300 and 1300, respectively. The expandable bladder may provide various advantages, such as assisting in taking up slack left in a flexible conduit 320, 1320, after the conduit has been at least partially inserted through an incision 14 and/or a pliable ring 323, 1323 has been positioned distal to the incision 14 (see
Similar to transorifice device 300, the port assembly 5310 may include a proximal side 5314 and a distal side 5315. Further, the flexible conduit 5320 may extend from the port assembly's distal side 5314 and the conduit 5320 may include a distal portion 5322. Additionally, the transorifice device 5300 may comprise at least one support member 5330 movable with respect to the distal portion 5322 of the flexible conduit and extendable to the port assembly's distal side 5315.
However, transorifice device 5300 may differ from transorifice device 300 in that the support member 5330 may comprise a rotatable push member 5331. Referring briefly to
In more detail, referring to
Moving back to the push member 5331, the push member's insertable portion 5334 may include at least one threaded side 5332 and at least one non-threaded side (not shown). The threaded side(s) 5332 may be the sides to the left and/or right of the insertable portion 5334 as illustrated in
Further, the locking hole 5318 may include threads 5319 on sides of the hole 5318 that correlate with the threaded sides 5332 of the insertable portion 5334. Further, the sides of the hole that are parallel to the plane of
Additionally, in various embodiments, the push member 5331 may be configured to be operable by a user while resisting freely falling out of the locking hole 5318. Accordingly, in at least one embodiment and referring to
While the above has discussed one push member 5331, it is contemplated that more than one push member 5331 may be associated with port assembly 5310 and/or flexible conduit 5320. Accordingly, in at least one embodiment and referring to
Further, as shown in
Additionally, although not shown, a support member may comprise a spring between the port portion and the conduit portion of a port assembly. Alternatively, or additionally, a spring may extend distally beyond the port assembly to engage a speculum, for example, thereby providing the port assembly with the ability to deflect during a surgical procedure, if desired.
Another embodiment of an exemplary transorifice device, transorifice device 2300, is illustrated in
Notably different from transorifice device 300, in at least one embodiment, transorifice device 2300 may not include a support member that may be positioned between the port assembly 2310 and a speculum, when the transorifice device 2300 is inserted at least partially through a speculum. However, in various alternative embodiments, a support member or members, as described herein, may be added to the transorifice device 2300, if desired.
In any event, similar to transorifice device 300, the transorifice device 2300, once properly positioned within a patient (discussed below), may be configured to provide a sealed passageway, through flexible conduit 2320, from outside a patient's body to body cavity. The pliable ring 2323, which may be positioned distal to an incision during a surgical procedure, may also prevent inadvertent removal or dislodgment of the distal portion 2322 from a patient's body, thereby retaining the transorifice device 2300 within the patient during a surgical procedure.
Moving now to
Further, in various embodiments, the delivery device's tip 2220 may be mounted to the distal end 2272 of the shaft 2270 such that movement of the shaft's proximal end 2271 effectuates movement of the tip 2220 relative to the foundation 2210. The tip 2220 may include a distal side 2221 and a proximal side 2222, wherein the proximal side 2222 defines an opening 2223 sized and configured to receive at least a portion of a surgical tool. For example, in at least one embodiment and as discussed in more detail below, the opening 2223 may be sized and configured to receive the pliable ring 2323 of transorifice device 2300, see
In at least one embodiment, referring back to
In various embodiments, the rigid body 2211 may also define at least one curve corresponding to the shaft. For instance, the rigid body 2211 may include a straight, linear portion 2212a located adjacent to the foundation 2210 and a curved, non-linear portion 2212b located distal to straight portion 2212 and/or adjacent to the tip 2220. Referring now to
Additionally, the surgical delivery device 2200, in at least one embodiment, may further comprise a handle 2280 attached to the proximal end 2271 of the shaft 2270. For example, the handle 2280 may be formed on or otherwise fixedly connected to the shaft's proximal end 2280. The handle 2280 may be configured for a user to grasp the handle 2280 and thereby move the shaft 2270 and, subsequently, the tip 2220 in a proximal or distal direction. For example, referring to
Further, in at least one embodiment, the handle 2280, the body 2211, and the shaft 2270 may cooperate to enable the tip 2220 to be moved a limited distance. In such embodiments, the body 2211 may also comprise a proximal end 2213 adjacent to the foundation 2210 and a distal end 2214. Also, the distance between the handle and the tip may be greater than the distance between the foundation and the distal end of the rigid body. Thus, referring still to
Additionally, the body 2211 may limit how far the tip 2220 may move in a proximal direction. In at least one embodiment, moving the handle 2280 in a proximal direction, e.g., toward the bottom of
In various embodiments, and as illustrated in
As mentioned above, the surgical delivery device 2200 may be configured to deliver a portion of a surgical device to a patient's body cavity. In various embodiments, the surgical delivery device 2200 may be configured to deliver a transorifice device, such as transorifice device 2300. In more detail, referring now to
As shown in
Next, the coupled transorifice device 2300 and surgical delivery device 2200 may be at least partially inserted into a patient as described above with respect to transorifice device 300 and delivery device 200, see
After inserting the tip 2220 into body cavity 20, the handle 2280 may be advanced in a distal direction to a distal position, such as that shown in
Next, the surgical delivery device 2200 may be removed from the patient. First, the foundation 2210 may be detached from the port assembly 2310. Then, the delivery device 2200 may be pulled in a proximal direction such that the tip 2220 is pulled through the flexible conduit 2320 and out port assembly 2310. In such embodiments, the outer diameter of the tip 2220 may thereby be smaller than the inner diameter of the flexible conduit 2320 and/or a port defined within port assembly 2310.
After removing the surgical delivery device 2200 from the transorifice device 2300, a surgical procedure may be performed through the transorifice device, as described above with respect to transorifice device 300 and
As noted above, the transorifice device's tip 2220 may be blunt. Alternatively, in various embodiments, the tip 2220 may be at least partially sharp and/or otherwise configured to make an incision in a patient's tissue, such as at otomy site 13, see
Additionally, the shaft 3270 may be similar to shaft 2270 described above. However, shaft 3270 may extend through the tip's curved portion 3220a to the incising portion 3220b. A lumen or tool receiving passageway 3211 may be defined by the inner surfaces of shaft 3270. The shaft 3270 and/or passageway 3211 may extend proximally past a foundation (not shown), similar to foundation 2210 shown in
The tip 3220 may function as a part of a surgical delivery device to deliver a surgical device to a body cavity, as described above with respect to delivery device 2200. Additionally, tip 3220 may cooperate with other features in a surgical delivery device to assist with delivering a surgical tool (e.g., as transorifice device 2300, see
In various embodiments, the devices may be made from various materials. By way of example, a surgical delivery device may be made from medical grade plastics and/or stainless steel. Further, a surgical delivery device may be disposable or reusable. Additionally, referring to a transorifice device, the flexible conduit and/or the extendable sleeves may be made from any biocompatible material or combination of materials such as, but not limited to, silicone, a polymer such as polyurethane, thermal plastic rubber (TPR), and/or a biocompatible metal such as stainless steel. Also, any other component of the devices described herein may also be made from one or more of the above materials. Further, surface treatments of the various device surfaces are possible. Such surface treatments may include altering the surface texture or adding a biocompatible coating such as silicone and/or a water-soluble personal lubricant, such as K-Y® jelly, to increase lubricity for easy passage of instruments, for example.
Further, while various embodiments disclosed herein contemplate using various components together as part of a surgical system, kit, and/or method, the individual components may be used independently as well. For example, a speculum, transorifice device, and/or surgical delivery device, according to any of the various embodiments, may be used independent of the other devices disclosed herein. Also, any or all of the instruments may be used in a non-NOTES procedure. For example, the various devices may be used through an incision made in the abdominal wall.
While the embodiments have been described, it should be apparent, however, that various modifications, alterations and adaptations to the embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the various embodiments. For example, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope and spirit of the appended claims.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device can utilize a variety of different techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
The devices described herein may be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. Alternatively a sterilizing gas or other sterilizing procedure may be used. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
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