The present invention relates generally to the field of surgical instruments, and more particularly relates to surgical instruments providing a passageway (lumen) through which fluids or other instrument components may be passed that is reinforced to prevent passageway collapse under bending forces. The instrument of some embodiments is a component of an electrosurgical wand in an electrosurgical system.
Surgical instruments with passageways, such as a shaft and internal lumen of an electrosurgical device, need to be bent during the performance of some surgical procedures, including but not limited to adenoidectomy. Such devices typically incorporate a suction or supply lumen for fluid and tissue passage through the shaft, which is being bent. Because the lumen may be made of a polymer and be operated under negative pressure and elevated temperature, the lumen may be prone to kinking when bent to a tight radius or bend angle. Similarly, the outer shaft around the lumen may be made from a metal that is a relatively soft annealed metal shaft. This metal shaft may be prone to kinking when bent to typical operating conditions. Such bending and kinking may restrict or even stop flow through the lumen.
Some manufacturers address flow restriction through lumen restriction by publishing bending guidelines in product Instructions For Use, recommending maximum bend angles to users. A reusable handheld bending guide to encourage a safe bend radius may also be provided. This solution may not allow a user to bend the device as much as desired for unique patient anatomies, and the bending guide is subject to being misplaced. Another prior art approach is to use more rigid, and expensive, Polyether ether ketone (PEEK) tubing and/or thicker tube walls to help increase the bending and collapse resistance of the lumen. These measures only address the problem in part. In addition to increased cost and geometric constraints within the device itself, where assembly and design clearances are often limited, these measures are unable to address the alternative failure mode in which the outer shaft kinks and crushes the lumen. It is also known in the prior art (especially with cardiovascular catheter instruments) to use flexible lumens that are reinforced by over-molding braided ribbons or very thin wires to provide structure within the tube walls. This is a relatively expensive solution that provides only limited support to the lumen in a configuration required for performing electrosurgical procedures. Such reinforced extrusions are effective at providing lumen support for torsion and axial resistance required for insertion of a catheter into tortuous cardiovascular anatomies, but ineffective at protecting a lumen from external crushing forces. Some manufacturers, such as is illustrated with Covidien's monopolar suction cautery device, have addressed the challenge by providing a polymer mandrel, such as a PTFE rod or filament, to be inserted through a shaft that serves as the suction passageway. Shaft integrity is enhanced by use of an aluminum shaft to prevent kinking. The polymer mandrel provides internal support for the lumen during bending and is removed to reveal the passageway that may be used while the device is bent. This approach incorporates an additional component and increases total cost. This approach also requires additional steps by an end user who, in addition to inserting and removing the mandrel each time a bend is desired, must also ensure that the mandrel remains readily accessible and sterile throughout the procedure.
It would be advantageous to provide surgical instruments that provide for adequate bending angles of the shaft and lumen to meet surgical needs while preventing restriction of passageways during bending. It may be further advantageous if instrument embodiments would provide enough bending resistance to prevent the instrument embodiments from being damaged when being subjected to typical use forces. It would be a cost advantage if components of the surgical instruments could be fabricated from off-the-shelf components more readily than prior art solutions that require over-molding and other relatively expensive manufacturing procedures.
An embodiment of the invention is a lumen that includes at least an inner tubular member with an inside diameter and an outside diameter along its length and a support coil. Embodiments of the support coil have an inside diameter and an outside diameter along its length, the support coil comprising a helically formed wire with a wire diameter, the wire extending helically along the length of the support coil to produce walls of the support coil. The walls of the support coil may be defined by extents of the wire at the inside diameter of the support coil and the outside diameter of the support coil. Substantially all of each revolution of the wire about the length of the support coil of some embodiments occurs within a respective distance along the length of the support coil of three wire diameters.
Another embodiment of the invention is an electrosurgical wand with a wand body having a proximal end and a distal end, wherein the distal end includes at least a portion that is flexible, a fluid supply port coupled near the proximal end of the wand body and communicating through the wand body to facilitate the provision of fluid at or near the distal end of the wand body, a suction port coupled near the proximal end of the wand body and communicating through the wand body to facilitate the provision of negative pressure at or near the distal end of the wand body, a lumen, and an electrosurgical conductor passing through at least a portion of the wand body to supply tissue affecting energy at or near the distal end of the wand body. Embodiments of the lumen are located within at least a part of the portion of the distal end that is flexible and provide a passageway. Lumen embodiments may include an inner tubular member with an inside diameter and an outside diameter along its length and a support coil. Embodiments of the support coil have an inside diameter and an outside diameter along its length, the support coil comprising a helically formed wire with a wire diameter, the wire extending helically along the length of the support coil to produce walls of the support coil. The walls of the support coil may be defined by extents of the wire at the inside diameter of the support coil and the outside diameter of the support coil. Substantially all of each revolution of the wire about the length of the support coil of some embodiments occurs within a respective distance along the length of the support coil of three wire diameters.
Yet another embodiment of the invention is an electrosurgical system that includes at least a controller, a fluid control unit electrically coupled to the controller, the fluid control unit configured to provide fluids at a rate coordinated with operation of the controller, and an electrosurgical wand electrically coupled to the controller and fluidly coupled to the fluid control unit. The electrosurgical wand may include a wand body with a proximal end and a distal end, wherein the distal end includes at least a portion that is flexible, a fluid supply port coupled between the fluid control unit and near the proximal end of the wand body and communicating through the wand body to facilitate the provision of fluid at or near the distal end of the wand body, a suction port coupled near the proximal end of the wand body and communicating through the wand body to facilitate the provision of negative pressure at or near the distal end of the wand body, and a lumen. The lumen may be located within at least a part of the portion of the distal end that is flexible, the lumen providing a passageway. The lumen may include at least an inner tubular member with an inside diameter and an outside diameter along its length, and a support coil with an inside diameter and an outside diameter along its length, the support coil comprising a helically formed wire with a wire diameter, the wire extending helically along the length of the support coil to produce walls of the support coil. The walls of the support coil may be defined by extents of the wire at the inside diameter of the support coil and the outside diameter of the support coil. Substantially all of each revolution of the wire about the length of the support coil may occur within a respective distance along the length of the support coil of three wire diameters. The electrosurgical wand may also include an electrosurgical conductor electrically coupled to the controller and passing through at least a portion of the wand body to supply tissue affecting energy at or near the distal end of the wand body.
Still another embodiment of the invention is a method of manufacturing a medical device that may include at least expanding a support coil with an inside diameter and an outside diameter along its length, the support coil comprising a helically formed wire with a wire diameter, the wire extending helically along the length of the support coil to produce walls of the support coil, inserting an inner tubular member with an inside diameter and an outside diameter along its length into the support coil inside diameter while the support coil is expanded, and causing the support coil to constrict around the inner tubular member such that the inside diameter of the support coil closely conforms to the outside diameter of the inner tubular member when the support coil is substantially straight along substantially all of its length.
Components of an embodiment of an electrosurgical system 1 are illustrated in
The fluid control unit 200 is configured to provide fluids at a rate coordinated with operation of the controller 100. For example, when tissue removal is switched on at the controller 100, or at external devices such as the external switching devices 150, fluid may be released from the fluid control unit 200. By way of non-limiting example, fluid may be a saline solution that works in conjunction with the electrosurgical wand 300 to accomplish cold ablation of tissue. The fluid control unit 200 may also include or be connected with a fluid reservoir such as an IV bag and may include a power switch 210 and a dial 220 or other control to designate a flow rate from the device.
In addition to electrical coupling to the controller 100 by the cable 301, the electrosurgical wand 300 may be fluidly coupled to the fluid control unit 200 by an irrigant tube 375. The electrosurgical wand 300 may also include a suction port 380 through which a negative pressure may be applied to the electrosurgical wand 300. A suction tube 385 may couple to the suction port 380 and be connected to an operating room suction system having, by way of non-limiting example, a suction pressure in the range of 250-350 mm Hg. In alternative embodiments, suction portion may be connected to a fluid control unit configured to control a negative pressure or rate of fluid removal from the tissue treatment site.
An embodiment of the electrosurgical wand 300 and its components are illustrated in more detail in
A fluid supply port 370 coupled between the fluid control unit 200 and near the proximal end 312 of the wand body 310 and communicating through the wand body 310 to facilitate the provision of fluid at or near the distal end 314 of the wand body 310 is shown in
The electrosurgical wand 300 embodiment illustrated includes a lumen 320 within at least a part of the portion of the distal end 314 of the wand body 310 that is flexible, as illustrated at least in
The inner tubular member 322 may in whole or in part be made from polyetheretherketone. In some embodiments, the inner tubular member 322 is substantially round and has an outside diameter of about 2.1 mm and a wall thickness of about 0.13 mm. This material and size selection enables some flexibility of the inner tubular member 322 while also providing some stiffness and some resistance to being crushed or collapsed under normal use. Additionally an inner tubular member that is electrically insulative may be preferable, to limit the current path between electrodes of the electrosurgical wand. An electrically conductive material may allow electrical currents to bridge to other unintended portions of the wand as the electrically conductive fluid travels there-along.
The electrosurgical wand 300 embodiment illustrated also includes a support coil 327 with an inside diameter and an outside diameter along its length. In some embodiments, the support coil 327 is substantially round and has an outside diameter of about 2.9 mm and a wall thickness of about 0.33 mm. The support coil 327 depicted has a helically formed metal wire with a wire diameter “D” (
As particularly illustrated in
As shown in
In addition to the passageway 325, a transfer space 319 may exist between the wand body 310 the lumen 320, as illustrated in
Electrosurgical system embodiments may also include an electrosurgical conductor electrically coupled to the controller 100 and passing through at least a portion of the wand body 310 to supply tissue affecting energy at or near the distal end of the wand body. The electrosurgical conductor may pass through, between, or among any combination or singular component of the electrosurgical wand 300 including but not limited to the wand body 310, the lumen 320, the inner tubular member 322, the support coil 327, the passageway 325, and the transfer space 319. One or more electrosurgical conductors may implement monopolar or bipolar tissue ablation, tissue cauterizing, or any other effective electrosurgical procedure or technique. In embodiments where the support coil 327, or a similar support component, is a conductor between the controller 100 and a distal electrode or other electrically operable component of the electrosurgical wand 300, a wire of such a support coil may be insulated.
A side elevation view of an embodiment of the electrosurgical wand 300 of the electrosurgical system 1 with a distal portion of the electrosurgical wand 300 in a bent state is illustrated in
In addition, a method of use may begin with placing a distal end of the wand near a target tissue, the wand distal end being oriented at a first angular orientation relative to a proximal end of the wand. This first orientation may be substantially straight or coaxial with the wand proximal end. Fluid may then be transferred along an inner tubular member of the wand, the inner tubular member having a support coil wrapped round the inner tubular member, as disclosed herein. The method may also include treating a target tissue electrosurgically and transferring treated tissue along the inner tubular member. The method further comprises plastically deforming a portion of the wand, such that the wand distal end is disposed at a second angular orientation relative to a proximal end of the wand, the wand configured to hold this second angular orientation. This second orientation is different from the first orientation. Fluid may then be transferred along the inner tubular member of the wand, the support coil wrapped round the inner tubular member as disclosed herein to support the inner tubular member and inhibit the inner tubular member from kinking. The method may further comprise plastically deforming a portion of the wand, such that the wand distal end is now oriented at a third angular orientation relative to a proximal end of the wand. This third orientation is different from at least one of the first or second orientation. Fluid may then be transferred along the inner tubular member of the wand, the support coil configured to inhibit the inner tubular member from kinking or deforming and thereby inhibit fluid flow. For example, the support coils assists in maintaining an opening along the inner tubular member to allow sufficient fluid to flow therethrough. In some embodiments, the steps of transferring fluid further comprises flowing treated tissue fragments therethough, and the support coil is configured to limit deformation of the inner tubular member to maintain a sufficient inner tubular member opening to allow passage of the tissue fragments therethrough.
Another embodiment of the invention is a method of manufacturing a medical device. The medical device may be, by way of non-limiting example, a lumen or an electrosurgical device that includes a lumen. Such method embodiments may include expanding a support coil, such as the support coil 327, with an inside diameter and an outside diameter along its length. The support coil 327 illustrated includes a helically formed wire with a wire diameter. The example wire illustrated extends helically along the length of the support coil 327 to produce walls of the support coil 327. The particular support coil 327 disclosed may be a standard medical grade spring such as an off-the-shelf extension spring. This type of spring is potentially much less expensive than a specially manufactured support coil, and even a greater savings compared to a support coil or other strand that has to be over-molded by another material to form the manufactured medical device.
The act of expanding the support coil 327 in some embodiments includes holding the support coil 327 at proximal and distal locations and applying a rotational force to the support coil 327 about an axis along the length of the support coil 327 in a direction opposite to the direction of winding of the helically formed wire that makes up the support coil 327. In other embodiments, expanding the support coil 327 may include applying a wedging force inside the support coil 327. For example, a wedged shaped mechanism such as a tapered mandrel may be forced inside the support coil 327 from one or both ends. In still other embodiments, expanding the support coil 327 may include placing an expandable mechanism in the support coil 327 and applying a force to increase the size of the expandable mechanism to a size that is large enough to expand the support coil 327.
The manufacturing method may also include inserting an inner tubular member, such as the inner tubular member 322 with an inside diameter and an outside diameter along its length into the support coil 327 inside diameter while the support coil 327 is expanded. Insertion of the inner tubular member 322 may occur while the support coil 327 is expanded to a size significantly larger than the outside diameter of the inner tubular member 322, or the fit may be tighter such that a lengthwise force is required to force the inner tubular member 322 into the support coil 327.
The manufacturing method may additionally include causing the support coil, such as the support coil 327, to constrict around the inner tubular member 322 such that the inside diameter of the support coil 327 closely conforms to the outside diameter of the inner tubular member 322 when the support coil 327 is substantially straight along substantially all of its length. An example straight support coil 327 conforming closely to the outside diameter of the inner tubular member 322 is shown in
In some embodiments, causing the support coil 327 to constrict includes waiting a period of time. For example, if the support coil 327 is made from a shape memory material, some period of time may need to be waited before an expanded support coil 327 will constrict around the inner tubular member 322. The period of time waited may also be merely the period of time after an inner tubular member 322 is moved into a support coil until the force used to move the components together is ended. Some acts causing the support coil 327 to constrict may also include changing the temperature of the support coil 327. In some embodiments, causing the support coil, such as support coil 327, to constrict includes applying a constricting force around the support coil 327. Causing the support coil 327 to constrict around the inner tubular member 322 may cause the distance between the inside diameter of the support coil 327 and the outside diameter of the inner tubular member 322 to be about 0.13 mm on average. In other embodiments, causing the support coil 327 to constrict around the inner tubular member causes the support coil 327 and the inner tubular member 322 to be in contact along substantially the entire length of the support coil 327.
Other embodiments of the method may include coupling a lumen, such as the lumen 320, inside an electrosurgical wand, such as the electrosurgical wand 300, to provide a flexible and collapse-resistant passageway through the electrosurgical wand 300. The lumen 320 may be offered as a separate medical device or device component, or may be incorporated into the electrosurgical wand 300 and sold as part of the electrosurgical wand 300. One or both of the lumen 320 and the electrosurgical wand 300 may also be offered as part of the electrosurgical system 1.
Various embodiments of a system wholly or its components individually may be made from any biocompatible material. For example and without limitation, biocompatible materials may include in whole or in part: non-reinforced polymers, reinforced polymers, metals, ceramics, adhesives, reinforced adhesives, and combinations of these materials. Reinforcing of polymers may be accomplished with carbon, metal, or glass or any other effective material. Examples of biocompatible polymer materials include polyamide base resins, polyethylene, Ultra High Molecular Weight (UHMW) polyethylene, low density polyethylene, polymethylmethacrylate (PMMA), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), a polymeric hydroxyethylmethacrylate (PHEMA), and polyurethane, any of which may be reinforced. Polymers used as bearing surfaces in particular may in whole or in part include one or more of cross-linked and highly cross-linked polyethylene. Example biocompatible metals include stainless steel and other steel alloys, cobalt chrome alloys, zirconium, oxidized zirconium, tantalum, titanium, titanium alloys, titanium-nickel alloys such as Nitinol and other superelastic or shape-memory metal alloys.
Terms such as proximal, distal, near, and the like have been used relatively herein. However, such terms are not limited to specific coordinate orientations, distances, or sizes, but are used to describe relative positions referencing particular embodiments. Such terms are not generally limiting to the scope of the claims made herein. Any embodiment or feature of any section, portion, or any other component shown or particularly described in relation to various embodiments of similar sections, portions, or components herein may be interchangeably applied to any other similar embodiment or feature shown or described herein.
While embodiments of the invention have been illustrated and described in detail in the disclosure, the disclosure is to be considered as illustrative and not restrictive in character. All changes and modifications that come within the spirit of the invention are to be considered within the scope of the disclosure.
This application is a U.S. National Phase Entry of PCT Application Serial No. PCT/US19/032240 filed May 14, 2019 and titled “LUMEN REINFORCEMENT DEVICE AND SYSTEM”, which claims the benefit of U.S. Provisional Application No. 62/674,207 filed May 21, 2018 entitled “LUMEN REINFORCEMENT DEVICE AND SYSTEM”, the entirety of which is incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US19/32240 | 5/14/2019 | WO | 00 |
Number | Date | Country | |
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62674207 | May 2018 | US |