# Patent

## Title
Nasal coagulation suction device and methods

## Abstract

A coagulation suction device that includes a hollow suction tube, at least first and second bipolar wires, and an insulation cover. The hollow suction tube includes a closed distal tip, a proximal open end, and at least one suction opening positioned proximal of the closed distal tip. A position of the closed distal tip is adjustable relative to remaining portions of the hollow suction tube. The at least first and second bipolar wires extend along the hollow suction tube to the closed distal tip. The at least first and second bipolar wires each having an exposed distal end. The insulation cover encapsulates the at least first and second bipolar wires along a length of the first and second bipolar wires and terminates proximal of the exposed distal ends of the at least first and second bipolar wires.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of the filing date of U.S. Provisional Application No. 62/138,579, filed Mar. 26, 2015, and entitled NASAL COAGULATION SUCTION DEVICE AND METHODS, the disclosure of which is incorporated herein, in its entirety, by this reference.


TECHNICAL FIELD
The present disclosure relates generally to medical devices and more particularly to nasal surgical devices and method for coagulation (and/or electrocautery) and suctioning during nasal surgery.
BACKGROUND
Sinus bleeding is one of the greatest obstacles faced by physicians practicing in the area of sinus/nasal surgery. Sinus bleeding is difficult to approach, often creates delays in surgeries, and can lead to costly complications.
Coagulation tools (also referred to as electrocauterization tools) utilize electrical energy to treat patient tissue such as bleeding sinus tissue. Coagulation procedures may be used to seal blood vessels during surgery to prevent blood flow. Ablation is utilized to vaporize or remove tissue using electrical energy. Coagulation probes may provide coagulation and ablation. Monopolar coagulation tools direct electric current from an active electrode of the tool through the patient's body and to a return electrode. The return electrode is usually defined by a grounding pad attached to the patient. Bipolar tools incorporate both an active and a return electrode into the tool.
A conductive irrigant such as saline is often used during surgical procedures utilizing bipolar tools. The saline solution provides a conduction path between the active and return electrodes of the tool. A high-frequency current delivered between the active and return electrodes effectively modifies tissue.
Some coagulation tools incorporate a suction feature to clear the surgical site of debris and other visual obstructions. The suction feature may be configured to permit a vacuum to be drawn through the tool from the distal end to a proximal point outside of the patient.
There has been an ongoing effort to reduce the size of surgical instruments whenever possible in order to reduce trauma to the patient. A number of challenges exist in creating a compact surgical instrument that includes both a suction tube as well as a coagulation feature. A further challenge related to coagulation tools having suction capability is clogging. When the treating portion or face of the coagulation electrode is in complete contact with tissue, suction through the opening into the suction tube can be temporarily stopped. This flow stoppage may result in the ablated tissue or other debris at the surgical location becoming lodges across the suction openings.
In view of these and other shortcomings related to existing coagulation suction devices, opportunities exist for improvements.
SUMMARY
One aspect of the present disclosure relates to a coagulation suction device (also referred to as an electrocauterization suction device) that includes a hollow suction tube, at least first and second bipolar wires, and an insulation cover. The hollow suction tube includes a closed distal tip, a proximal open end, and at least one suction opening positioned proximal of the closed distal tip. A position of the closed distal tip is adjustable relative to remaining portions of the hollow suction tube. The first and second bipolar wires extend along the hollow suction tube to the closed distal tip. The first and second bipolar wires each having an exposed distal end. The insulation cover encapsulates the first and second bipolar wires along a length of the first and second bipolar wires and terminates proximal of the exposed distal ends of the first and second bipolar wires.
The insulation cover may terminate proximal of the at least one suction opening. The at least one suction opening may include at least first and second suction openings. The at least first and second suction openings may be arranged opposite each other around a circumference of the hollow suction tube. The at least one suction opening may include an oblong shape. The first and second bipolar wires may be positioned on opposite sides of each other around a circumference of the hollow suction tube. The coagulation suction device may also include a suction control device positioned at a proximal end portion of the hollow suction tube. The suction control device may include a thumb actuated suction opening in flow communication with an interior of the hollow suction tube. The coagulation suction device may include a suction tubing attachment device positioned at the proximal open end of the hollow suction tube. The coagulation suction device may include a bipolar plug positioned at a proximal end of the first and second bipolar wires. The distal ends of the first and second bipolar wires may be exposed along a distal end surface of the closed distal tip of the hollow suction tube. The hollow suction tube may include a malleable material to provide adjustability of the closed distal tip relative to remaining portions of the hollow suction tube. The hollow suction tube and the insulation cover may comprise polymer materials. The insulation cover ma encapsulate the hollow suction tube proximally along at least a portion of a length of the hollow suction tube from a location proximal of the at least one suction opening.
Another aspect of the present disclosure relates to a coagulation suction device that includes a hollow suction tube, a plurality of bipolar wires, at least one suction opening, and an insulation cover. The hollow suction tube includes a closed distal tip located at a distal end portion thereof. The hollow suction tube includes a malleable portion to provide self-adjustment of an orientation of the closed distal tip internal a body cavity. An orientation of the closed distal tip may be adjustable from external the patient while the closed distal tip is located within a body cavity of the patient. The plurality of bipolar wires are each exposed along and terminate at the closed distal tip of the hollow suction tube. The at least one suction opening is formed in the hollow suction tube at the distal end portion at a location proximal of the closed distal tip. The insulation cover encapsulates the plurality of bipolar wires and hollow suction tube.
The coagulation suction device may include a suction control member positioned at a proximal end portion of the hollow suction tube and operable to control suction forces available at the at least one suction opening. The at least one suction opening may include a plurality of suction openings. The insulation cover may terminate proximal of the at least one suction opening. The closed distal tip of the hollow suction tube may define a hemispherical shape distal end surface of the hollow suction tube.
A further aspect of the present disclosure is directed to a method of manufacturing an coagulation suction device. The method includes providing a hollow suction tube, plurality of bipolar wires, and an insulation cover. The method also includes closing a distal tip of the hollow suction tube, forming at least one suction opening in a distal end portion of the hollow suction tube at a location proximal of the closed distal tip, arranging the plurality of bipolar wires along a least a portion of a length of the hollow suction tube with distal ends of the plurality of bipolar wires terminating at the closed distal tip, and encapsulating the plurality of bipolar wires with the insulation cover. The insulation cover is arranged so that the distal ends of the plurality of bipolar wires, the closed distal tip of the hollow suction tube, and the at least one suction opening are exposed.
The method may further include providing the hollow suction tube with an adjustable portion that provides adjustment of an orientation of the closed distal tip relative to other portions of the hollow suction tube. The method may include mounting a suction control device to a proximal end portion of the hollow suction tube, wherein the suction control device provides adjustment of a suction force available at the at least one suction opening. Forming at least one suction opening may include forming a plurality of suction openings in the distal end portion of the hollow suction tube.
Another embodiment is directed to a method of manufacturing a coagulation suction device. The method includes providing a catheter having at least one suction lumen, and a plurality of bipolar wires extending within the catheter along at least a portion of a length of the catheter, closing a distal tip of the catheter, forming at least one suction opening in a side surface of the catheter at a distal end portion of the catheter at a location proximal of the closed distal tip, and arranging distal ends of the plurality of bipolar wires between the closed distal tip and the at least one suction opening.
The method may also include providing a tip adjustable portion operable from a location outside of a patient to adjust an orientation of the closed distal tip. The method may include providing at least two pairs of bipolar wires. Forming at least one suction opening may include forming a plurality of suction openings in the distal end portion of the hollow suction tube. The method may include providing the catheter with a separate wire lumen to receive each of the plurality of bipolar wires. The method may include encapsulating portions of each of the plurality of bipolar wires in the catheter.
Additional advantages and novel features of the invention will be set forth in the description which follows or may be learned by those skilled in the art through reading these materials or practicing the examples disclosed herein.



BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings illustrate various embodiments of the present invention and are a part of the specification. The illustrated embodiments are merely examples and do not limit the scope of the present disclosure.
FIG. 1 is a side view of an example surgical device in accordance with the present disclosure.
FIG. 2 is an end view of the surgical device shown in FIG. 1.
FIG. 3 is a cross-sectional view of the surgical device shown in FIG. 1 taken along cross-section indicators 3-3.
FIG. 4 is a cross-sectional view of a wire extension portion of the surgical device shown in FIG. 1 taken along cross-section indicators 4-4.
FIG. 5 is a close-up side view of an end portion of the surgical device shown in FIG. 1.
FIG. 6 is a close-up top view of the end portion of the surgical device shown in FIG. 1.
FIG. 7 is a cross-sectional view of the surgical device shown in FIG. 5 taken along cross-section indicators 7-7.
FIG. 8 is a side view of another example surgical device in accordance with the present disclosure.
FIG. 9 is an end view of the surgical device shown in FIG. 8.
FIG. 10 is a cross-sectional view of the surgical device shown in FIG. 8 taken along cross-section indicators 10-10.
FIG. 11 is a cross-sectional view of a suction control portion of the surgical device shown in FIG. 8 taken along cross-section indicators 11-11.
FIG. 12 is a close-up side view of an end portion of the surgical device shown in FIG. 8.
FIG. 13 is a close-up top view of the end portion of the surgical device shown in FIG. 8.
FIG. 14 is a cross-sectional view of another example surgical device having four internal lumens in accordance with the present disclosure.
FIG. 15 is a cross-sectional view of another example surgical device having five internal lumens in accordance with the present disclosure.
FIG. 16 is a side view of an end portion of another example surgical device in accordance with the present disclosure.
FIG. 17 is a top view of the end portion shown in FIG. 16.
FIG. 18 is an end view of the end portion shown in FIG. 16.



Throughout the drawings, identical reference numbers designate similar, but not necessarily identical, elements.
DETAILED DESCRIPTION
The present disclosure is directed primarily to surgical devices for use in nasal and sinus cavities. However, the principles disclosed herein may be generally applicable for use in treating other parts of the body. Generally, the surgical devices disclosed herein may be classified as coagulation devices and/or electrocauterization devices. The inclusion of suction capability with the surgical devices disclosed herein may classify the devices as coagulation suction devices. In at least some examples, the devices and/or methods disclosed herein may relate to nasal coagulation suction devices and related methods of treatment.
A number of challenges exist when working in the nasal and sinus cavities. For example, the sinuses are delicate and often difficult to work in because of their limited space and obscure location relative to an exterior of a patient. Operations in the sinuses pose the potential of damaging the optic nerve, frontal lobe, or other organs and/or vessels in the head. Bleeding in the sinuses and during sinus operations typically makes it difficult to observe the surgical site, thereby potentially decreasing accuracy and safety during surgery. Current methods of treating bleeding vessels in the sinuses are often too lengthy, complex, or ineffective. Cautery is often too aggressive and may cause excess damage to surrounding tissue. The nature of the sinuses is such that it may be difficult to navigate with currently known devices. Current methods and devices may introduce potential for additional errors, particularly when surgical technicians are carrying out the procedure. Additionally, current suction cautery devices and related methods locate cautery functions around the suction openings, which may cause clotting that blocks the suction opening.
The surgical devices of the present disclosure may include a bipolar cautery configuration which may provide improved cauterization as compared to a monopolar arrangement. The surgical devices may include a malleable and/or steerable tip that provides improved ease in navigating within the nasal and sinus cavities and may provide lower risk of damaging tissue while navigating to and from a surgical site. The malleable tip and/or features positioned thereon may be controllable without removing the device from the cavity. The malleable features may provide a self-orienting feature for the surgical device. In some embodiments, the surgical device may include a tip steering mechanism that provide a change in orientation and/or direction of the distal end portion of the surgical device from a location outside of the patient while the distal end portion is positioned in a body cavity of the patient. The surgical device may include suction which helps remove blood and debris at a surgical site. The suction openings may be positioned on one or more side surfaces of a suction tube of the surgical device. The suction openings may be spaced proximal of a distal tip of the surgical device, and may be positioned proximal of the bipolar cautery wires (i.e., tips of the bipolar cautery wires). The surgical device may have a relatively small profile in the range of about, for example, 3 F to about 10 F, and more preferably in the range of about 6 F to about 8 F. The distal tip of the surgical device may include a nonstick coating that limits collection of tissue, debris, and the like. In at least one example, the nonstick coating includes Teflon®.
The present description provides examples, and is not limiting of the scope, applicability, or configuration set forth in the claims. Thus, it will be understood that changes may be made in the function and arrangement of elements discussed without departing from the spirit and scope of the disclosure, and various embodiments may omit, substitute, or add other procedures or components as appropriate. For instance, the methods described may be performed in an order different from that described, and various steps may be added, omitted, or combined. Also, features described with respect to certain embodiments may be combined in other embodiments.
Referring first to FIGS. 1-7, and particularly FIG. 1, a surgical device 10 is shown and described. The surgical device 10 may be a coagulation suction device. The surgical device 10 may be particularly useful within the nasal and sinus cavities of a patient, although it may be used in other applications, such as for treatment of a patient at other locations within the body. Certain features of the surgical device 10 may be modified for use in treating other aspects of a patient. For example, an insertion length of the surgical device 10 may be increased when the surgical device is to be used to treat the esophagus or stomach of a patient, or may be reduced in length when the surgical device is used to treat cavities closer to an exterior surface of the patient.
Surgical device 10 may include a suction tube 12, a pair of bipolar wires 14, 16, an insulation cover 18, a suction control member 20, a suction tubing attachment 22, a wire extension 24, and a wire plug 26, as shown in FIG. 1. The surgical device 10 may include an insertion portion having a length L1. The surgical device 10 may have a profile at a location along its length L1 having a width W and a thickness T, as shown in FIG. 2. The width W and thickness T may be substantially the same in some embodiments, whereas in other embodiments, such as the one shown in FIG. 2, the width W is greater than the thickness T. In at least some embodiments, the maximum dimension of a cross-section of the surgical device 10 (e.g., the width W in the embodiment shown in FIG. 2) is in the range of about 3 F to about 10 F, and more particularly in the range of about 6 F to about 7 F. Other maximum cross-sectional dimensions may be possible including dimensions greater than 10 F (e.g., in the range of about 10 F to about 20 F). Further, smaller sizes may be possible as improvements are made in materials, manufacturing, and the like to provide sizes less than 3 F (e.g., in the range of about 1 F to about 3 F).
The suction tube 12 may include a tip 30, a pair of suction ports 32, 34 positioned opposite each other around a circumference of the suction tube 12, and an exposed portion 36 that is arranged distal of a distal most point of the insulation cover 18. Further, suction tube 12 may include a suction lumen 38 (see FIG. 3). The suction ports 32, 34 may be in flow communication with suction lumen 38 as well as the suction control member 20 and the suction tubing attachment 22. An operator may control the amount of suction force available at the suction ports 32, 34 by operating the suction control member 20. Suction control member 20 may include an opening 42 that the operator covers or partially covers with a thumb, finger or other object to control the suction force applied at suction ports 32, 34. Opening 42 may be in flow communication with the suction lumen 38 of suction tube 12.
The suction ports 32, 34 may be spaced proximal of the distal tip 30 a distance X1 (see FIG. 5). The distance X1 may be in the range of about 1 mm to about 20 mm, and more particularly in the range of about 2 mm to about 5 mm. The suction ports 32, 34 may have a diameter (e.g., maximum dimension) in the range of about 0.1 mm to about 10 mm, and more particularly in the range of about 1 mm to about 7 mm.
The suction ports 32, 34 may also be positioned proximal of distal ends 40 of bipolar wires 14, 16 (see FIG. 6). The arrangement of suction ports 32, 34 at a location proximal of the tip 30 and distal ends 40 of the bipolar wires 14, 16 may limit potential problems of clogging the suction ports 32, 34 with coagulated blood, cauterized tissue, or other debris or objects located in the area of a surgical site. The suction ports 32, 34 are shown having a generally circular shape as shown in at least FIG. 6. Other shapes and sizes are possible for the suction ports 32, 34 including, for example, oval shaped profiles.
The suction ports 32, 34 are located on opposite side surfaces of suction tube 12 (see FIG. 5). The suction port 32 may be positioned along a top side of the surgical device 10 and be referred to as a superior suction port 32. The suction port 34 may be positioned along a bottom side of the surgical device 10 and be referred to as an inferior suction port 34. The suction ports 32, 34 are located at a common longitudinal point along the length of suction tube 12. Other arrangements are possible in which the suction ports 32, 34 are offset longitudinally relative to each other, positioned at other circumferential locations relative to each other besides at direct opposite positions, and may be positioned at various circumferential and longitudinal positions relative to the distal ends 40 of bipolar wires 14, 16 and tip 30. In some arrangements, distal ends 40 of the bipolar wires 14, 16 are positioned offset longitudinally relative to each other, and the suction ports 32, 34 are offset longitudinally relative to each other and/or relative to the distal ends 40 of bipolar wires 14, 16.
Other embodiments are possible in which more than two suction ports 32, 34 are included on a single suction tube 12. For example, three or more suction ports may be positioned at a common longitudinal position along the length of suction tube 12 and offset equally around a circumference of suction tube 12. In still further examples, a single suction port is included on suction tube 12. For example, FIGS. 12 and 13 show a surgical device 200 that includes a single suction port 232 formed in suction tube 212. The single suction port 232 is positioned proximal of distal ends 240 of bipolar wires 214, 216, and proximal of the distal tip 230 of suction tube 212. Suction port 232 is positioned distal of a distal most end of insulation cover 218. Further, suction port 232 is shown including a circular profile (see FIG. 13), but may include other shapes, sizes and orientations in other embodiments.
Referring again to FIGS. 1-7, the suction tube 12 includes an exposed portion 36 that extends distally beyond a distal most point of insulation cover 18. Exposed portion 36 has a length LE as shown in FIG. 1. The length LE may vary depending on a variety of factors including, for example, the size and shape of suction ports 32, 34, the size and shape of distal tip 30, the size, shape and orientation of bipolar wires 14, 16 and their distal ends 40, and the like. In one example, the length LE is in the range of about 1 mm to about 20 mm, and more particularly in the range of about 2 to about 10 mm.
The distal ends 40 of bipolar wires 14, 16 are typically spaced proximal of a distal most end of tip 30. FIG. 5 shows distal ends 40 spaced a distance X2 from the distal most tip 30. The distance X2 may be in the range of about 0.5 mm to about 2 mm, and more particularly about 0.1 mm to about 1 mm. The distal ends 40 may include and/or be formed as a bulbous portion and/or have a spherical shaped portion. Distal ends 40 may be specifically sized, arranged and/or configured to provide improved cauterization of tissue. The distal ends 40 may be positioned at tip 30 or may extend distally beyond tip 30. The bipolar wires 14, 16 may be adjustable axially to position distal ends 40 at various positions relative to tip 30 during delivery and/or operation of surgical device 10.
In some embodiments, the suction tube 12 comprises a metallic material or other electrically conductive material (e.g., stainless steel). In other embodiments, the suction tube 12 comprises a polymer material such as Pebax®, polyurethane or polypropylene. The suction tube 12 may comprise the same material as the insulation cover 18. In some embodiments, the suction tube 12 is a continuous, integrally formed structure with the insulation cover 18 (e.g., formed by co-extrusion, co-molding, heat forming, or the like). The suction tube 12, or at least the tip 30 positioned adjacent to distal ends 40, may provide a conducting surface between the distal ends 40 of the bipolar wires 14, 16. In at least some examples, the bipolar wires 14, 16 comprise a conductive metallic material such as, for example, copper. Other suitable materials for bipolar wires 14, 16 include Aluminum.
Operation of bipolar wires 14, 16 to provide coagulation and/or cauterization may be controlled from a remote location. The bipolar wires 14, 16 may extend within insulation cover 18 along the insertion length L1 along the length of suction tube 12. At some point proximal of the insertion length L1, the bipolar wires 14, 16 may detach from suction tube 12 as wire extension 24. Wire extension 24 may connect with a control member via wire plug 26. The control member may include, for example, a foot-actuated pedal or other control device. The actuator may control the amount of power supplied to the distal ends 40 for purposes of cauterizing or otherwise treating tissue (e.g., a vessel) at a surgical site.
The surgical device 10 is shown including a single pair of bipolar wires 14, 16. Other embodiments may include more than two bipolar wires 14, 16, such as two or more pairs of bipolar wires 14, 16. The pairs of bipolar wires 14, 16 may terminate at different distal locations along the length of suction tube 12. For example, one pair of bipolar wires 14, 16 may terminate at distal tip 30, while other pairs of bipolar wires 14, 16 may terminate at locations spaced between distal tip 30 and suction ports 32, 34, or at locations proximal of suction ports 32, 34.
The insulation cover 18 may encapsulate the bipolar wires 14, 16 except in the area of distal ends 40 where the bipolar wires 14, 16 are exposed for the purpose of cauterizing or otherwise treating tissue. Insulation cover 18 may comprise a polymer material such as, for example, polypropylene, polyurethane, FEP (fluorinated ethylene propylene), or Pebax® thermoplastic elastomer material. In at least some examples, bipolar wires 14, 16 and suction tube 12 are co-molded together within insulation cover 18. Insulation cover 18 may be referred to as a catheter or a catheter member. Typically, insulation cover 18 comprises an electrically nonconductive material. Insulation cover 18 provides an insulation layer between the suction tube 12 and the bipolar wires 14, 16 along at least the insertion portion having length The bipolar wires 14, 16 may be referred to as lateral and medial bipolar wires 14, 16, respectively, or may be referred to as opposed bipolar wires 14, 16 (e.g., arranged on opposite sides of tip 30). FIG. 3 shows a cross-sectional view of the insertion portion of surgical device 10 and at least a portion of the insulation cover 18 interposed between the suction tube 12 outer surface and the bipolar wires 14, 16. FIG. 4 shows the insulation cover 18 providing an insulating layer between bipolar wires 14, 16 along at least the wire extension 24.
The surgical device 10 may include a malleable distal portion 28 (see FIG. 1). The distal portion 28 may be malleable in the sense that it can be shaped, altered in orientation, and/or comprise flexibility properties. The malleable nature of distal portion 28 may provide for improved navigation around corners and through otherwise tortuous paths in the body, such as through nasal and sinus cavities. Distal portion 28 may include materials that provide at least some malleability for the surgical device 10. Distal portion 28 may include shapes and sizes that also provide malleability properties for surgical device 10. For example, tip 30 may include a bulbous construction as shown in FIGS. 2, 5 and 6. The bulbous construction of tip 30 may provide less friction and/or obstructions at the distal end of surgical device 10 that provides improved navigation through bodily cavities within which surgical device 10 is used. Tip 30 may be defined as having a hemispherical or spherical shaped construction. Malleable distal portion 28 may have a length LM. Surgical device 10 may include structural features such as, for example, reduced material thicknesses, different material compositions, and the like that provide improved malleability of distal portion 28 as compared to other portions of surgical device 10 that are located proximal of distal portion 28.
In some embodiments, malleable distal portion 28 may include a coating along at least portions thereof. The coating may comprise a nonstick or low friction property. In one example, the coating comprises Teflon® or other low surface friction material. Other example coating materials include Pebax, Peek (polyetheretherketone), PEG (polyethylene glycol), and other medical coatings available from, for example, Hydromer® of Branchburg, N.J. Another suitable coating material includes a stimulus-responsive polymer such as N-isopropyl acrylamide (NIPAAm) or other thermally or electro-responsive polymer to provide a low friction surface.
In at least some examples, the tip 30 of suction tube 12 comprises a different material than the remaining portions of suction tube 12. For example, the hemispherical shaped tip 30 may comprise a material having a lower density, softer feel, lower friction, or other property. For example, tip 30 may comprise a polymer material (or a first polymer material) while the remaining portions of suction tube 12 comprise a metal material or second polymer material, wherein the material of the remaining portions of the suction tube 12 provides the desired properties for suction and for operation of the bipolar electrodes to create coagulation and/or hemostasis at a surgical site.
Generally, the materials, shape, size and other characteristics of tip 30 and/or distal portion 28 generally, provide reduced tissue adhesion during coagulation. In some embodiments, the tip 30 may have a relatively rigid construction to assist in navigating passages and cavities of the body.
The length LM of the distal portion 28 is typically in the range of about 0.5 cm to about 5 cm, and more preferably in the range of about 1 cm to about 4 cm. The distal portion 28 may have malleable properties to provide improved self-adjustment of an orientation and/or shape of the distal portion 28 while navigating passages and cavities of the body. The distal portion 28 may be steerable or include steerable properties. An orientation of distal portion 28 may be adjustable from a location outside of the patient while the distal portion 28 is positioned within a body cavity. In some embodiments, the distal portion 28 may be adjusted into a certain shape or orientation while positioned outside of the patient and maintain that shape or orientation when inserted into a body cavity. This may be referred to as a shape memory property. In yet other embodiments, the distal portion 28 may include a shape memory material that takes on a different shape or orientation when inserted into a body cavity. The shape memory material may take on a different shape and/or orientation when exposed to a certain temperate (e.g., a temperature activated material that changes shape when heated to body temperature), or when exposed to an electrical stimulus (e.g., an electrical activated material that changes shape when stimulated with an electrical charge).
Referring now to FIGS. 8-11, another example surgical device 100 is shown and described. Surgical device 100 may include many of the same or similar features as described above with reference to surgical device 10. For example, surgical device 100 includes a suction tube 112, a pair of bipolar wires 114, 116, an insulation cover 118, a suction control member 120, a suction tubing attachment 122, a wire extension 124, and a wire plug 126. The surgical device 100 may include a malleable distal portion 128.
The suction tube 112 may include a tip 130, first and second suction ports 132, 134, and a suction lumen 138 (see FIG. 10). In some embodiments, the suction tube 112 is formed integral as a single piece with the insulation cover 118. The bipolar wires 114, 116 may each include a distal end 140.
The insulation cover 118 may be configured as a catheter type structure with a plurality of lumens 150, 152, 154 (see FIGS. 10 and 11). The lumen 150 is sized for insertion of suction tube 112. In some embodiments, lumen 150 takes the place of suction tube 112, wherein a suction force is applied directly within lumen 150. Insulation cover 118 may be referred to as a multi-lumen catheter. In some embodiments, insulation cover 118 may have a modified shape at its distal end in which lumens 152, 154 are eliminated (e.g., to exposed distal end portions of bipolar wires 114, 116), and the suction ports 132, 134 are formed in side surfaces of insulation cover 118 to provide access into lumen 150 where a suction force is applied.
Lumens 152, 154 are sized to receive the bipolar wires 114, 116. In at least some examples, the suction tube 112 and bipolar wires 114, 116 may be able to advance and retract longitudinally relative to the lumens 150, 152, 154 of insulation cover 118. Insulation cover 118 may be referred to as a tri-lumen device and/or catheter. The surgical device 100 may be assembled by inserting the suction tube 112 and bipolar wires 114, 116 into insulation cover 118 (e.g., as compared to co-molding, bonding, or other forming methods that may be possible).
The lumens 150, 152, 154 are shown in at least FIGS. 10 and 11 arranged side-by-side across a width of the insulation cover 118. Other arrangements are possible for positioning of the lumens 150, 152, 154 relative to each other. Further, the size and shape of the lumens 150, 152, 154 may be modified as desired to accommodate different sizes, cross-sectional shapes, materials, and the like for any of the suction tube 112, bipolar wires 114, 116 and other devices inserted therein.
Any of the lumens 150, 152, 154 may be provided with a greater diameter or other internal dimension as compared to the diameter or other outer dimension of the device inserted therein. A space or cavity may be interposed between the inner surface of the lumens and the respective component inserted therein. This cavity or space may be used to deliver other objects or materials to a surgical site. In at least one example, a cavity provided between an outer surface of suction tube 112 and an inner surface of lumen 150 may provide a delivery passage for saline or other fluid to be delivered to a surgical site. In another example, another device may be inserted over an exterior of any one of suction tube 112 and bipolar wires 114, 166 and within a respective lumen 150, 152, 154. In a still further example, a device may be inserted within the internal suction lumen 138 of suction tube 112 for delivery to a surgical site. Such a device may travel through suction lumen 138 and out of suction ports 132, 134. In still further examples, a fluid may be delivered to the surgical site via the suction lumen 138 of suction tube 112, for example, prior to applying a suction force within suction lumen 138. In other embodiments, a fluid may be delivered through any of the lumens 150, 152, 154 of insulation cover 118.
FIG. 8 shows another example suction control member 120 that is positioned over both the insulation cover 118 as well as the suction tube 112. FIG. 11 shows a cross-sectional view of surgical device 100 in which the opening 142 is shown in flow communication with the suction lumen 138 to provide manual control of an amount of suction force applied at suction ports 132, 134. Other control mechanisms and/or features may be possible in place of or in combination with manually controlled opening 142. In some embodiments, suction control member 120 may provide a structure for separating the bipolar wires 114, 116 and associated insulation cover 118 from the suction tube 112. FIG. 8 shows the wire extension 124 separating from the insulation cover 118 at a location adjacent to suction tubing attachment 122. Many other embodiments and configurations are possible for separating the wire extension 124 from suction tube 112 and insulation cover 118. In some examples, the bipolar wires 114, 116 are encapsulated within wire extension 124, whereas in other embodiments the wire extension 124 includes separate lumens within which the bipolar wires 114, 116 are positioned. The wire extension 124 may be considered a multi-lumen catheter that carries the bipolar wires 114, 116.
FIGS. 14 and 15 illustrate further example surgical devices 300, 400 that include additional lumens. FIG. 14 shows a surgical device 300 having four lumens 350, 352, 354, 356 formed in an insulation cover 318. The lumen 350 carries a suction tube 312. The lumens 352, 354 carry bipolar wires 314, 316. The lumen 356 may be used for various purposes including, for example, delivery of a fluid to a surgical site at a distal end portion of the surgical device 300. Lumen 356 may be used to deliver another device and/or component such as, for example, a light fixture, a camera, a gripping or grasping member, a guidewire, a gauze member, medications, pressurized air, a needle, a cutting device, or the like. Various instruments or other materials may be inserted into and removed from lumen 356 prior to, during, and/or after treatment of tissue at a surgical site using surgical device 300.
FIG. 15 shows a surgical device 400 having an insulation cover 418 with five lumens 450, 452, 454, 456, 458. Lumen 450 may receive suction tube 412. Lumens 452, 454 may receive bipolar wires 414, 416. Lumen 456 and 458 may receive or deliver various materials, components, instruments, and the like to or from a surgical site. FIG. 15 shows the lumen 456 empty, although lumen 456 may be filled with a fluid such as a medication, saline solution, pressurized gas, or the like. Lumen 458 is shown including a device 460 and a wire 462. In one example, the device 460 comprises a light or camera. The wire 462 may provide power to the light or camera. In another example, the device 460 and/or wire 462 may be part of a tip control mechanism used to control an orientation of the distal tip of the suction tube 412 and or distal end portion of the surgical device 400 generally. The tip control mechanism may be operable from outside of the patient while the surgical device 400 is positioned within a body cavity of a patient.
Either one of the lumens 456, 458 may be used to deliver instruments, fluids, drugs, or other components needed to carry out a procedure. In some examples, the lumens 456, 458 may be receptive of additional bipolar wires whose distal tips are exposed at a distal end portion of the surgical device 400 (e.g., at distal tip of suction tube 412 or at a location spaced between the distal tip of suction tube 412 and the suction ports of the suction tube 412). For example, wire 462 may be a bipolar wire that is used for coagulation and/or electrocauterization. In other embodiments, a plurality of bipolar wires may extend through any one of or a multiple ones of the lumens 450, 452, 454, 456, 458. The bipolar wires may each include a separate insulation cover to provide electrical insulation from other bipolar wires positioned within a common lumen of the catheter 418. Each bipolar wire or pair of bipolar wire may be separately controlled to provide an operator with many options for treating tissue at an operation site (e.g., increasing or decreasing a cauterizing field).
FIG. 14 shows the surgical device 300 having a generally elliptical shaped cross-section while surgical device 400 shown in FIG. 15 has a circular shaped cross-section. The cross-sectional shape of any of the surgical devices disclosed herein may be modified to provide a minimum, lowest profile shape and size possible while still providing the desired number, shape and size of lumens and/or an amount of insulating material needed for purposes of carrying out a coagulation suction procedure using the surgical device. One potential advantage of the surgical devices disclosed herein is the reduced profile and the use of a single, compact device for insertion through the nasal and sinus cavities to the surgical site. Even when an insulating cover and/or catheter having a plurality of lumens is used, all of the lumens and the related devices carried in the lumens are consolidated within a single instrument that is inserted into the patient. This use of a single instrument may reduce the complexity of the procedure and provide other advantages such as, for example, reduced damage to tissue when entering and exiting the nasal and sinus cavities, being able to insert and/or operate the surgical device with a single hand or by a single person, and easier navigation to a surgical site.
FIGS. 16-18 show an end portion of another example surgical device 500. The surgical device includes two pairs of bipolar wires 514a, 516a and 514b, 516b, a multi-lumen catheter 518 (also referred to as an insulation cover 518), and steering mechanisms 570, 572.
The bipolar wires 514a, 516a and 514b, 516b may be positioned spaced apart around a circumference of catheter 518 at distal portion 528. Each pair of bipolar wires 514a, 516a and 514b, 516b may be positioned opposite each other along an exterior of the catheter 518. The bipolar wires 514a, 516a and 514b, 516b may terminate at different distal locations relative to a tip 530 of catheter 518. For example, bipolar wires 514a, 516a may terminate closer to suction ports 532, 534 of catheter 518, while bipolar wires 514b, 516b may terminate closer to tip 530. In other examples, the bipolar wires 514a, 516a and 514b, 516b all terminate at approximately the same longitudinal position along the length of the surgical device 500 (e.g. position relative to tip 530). The bipolar wires 514a, 516a and 514b, 516b may all terminate at locations between tip 530 and suction ports 532, 534. In other embodiments, one or more of the bipolar wires 514a, 516a and 514b, 516b may terminate at a location spaced distal of tip 530 or at a location spaced proximal of one or more of suction ports 532, 534.
The bipolar wires 514a, 516a and 514b, 516b may be individually controllable to provide cauterization and/or coagulation at a treatment site. In one example, the pair of bipolar wires 514b, 516b may be operable for a first period of time, and when the operator additionally operates the pair of bipolar wires 514a, 516a when he would like to increase a magnitude of cauterization. The operator may turn off either pair of bipolar wires 514a, 516a and 514b, 516b when he would like to reduce the magnitude of cauterization. When the bipolar wires 514a, 516a and 514b, 516b terminate at different locations relative to tip 530, the operator may operate different one of the bipolar wires 514a, 516a and 514b, 516b to cauterize at specification locations without having to adjust an axial position of surgical device 500. When the bipolar wires 514a, 516a and 514b, 516b all terminate at a common axial position, the operator may operate certain ones of the bipolar wires 514a, 516a and 514b, 516b to provide cauterization at specification circumferential locations at the treatment site. In some embodiments, additional pairs of bipolar wires may be used at any desired location, orientation, and the like to optimize or customize the cauterization/coagulation options available to the operator.
The catheter 518 may include steering lumens 562, 564 that receive steering mechanisms 570, 572, respectively. The catheter 518 may also include a suction lumen (not shown) that is in flow communication with the suction ports 532, 534. The suction lumen may be an example of the suction lumen 38 shown in FIG. 1 or the tube lumen 150 shown in FIG. 10. The catheter 518 may be provided as a single piece that is either bonded or connected together as a single piece (e.g., co-molded, heat bonded, or the like), or extruded as a single piece.
The steering mechanisms 570, 572 may be connected to catheter 518 at a distal connection point 574. The steering mechanisms 570, 572 may extend to a proximal end of the surgical device 500 where the steering mechanisms 570, 572 are operable at a location outside of the patient. In at least one example, applying an axial force at a proximal end portion of steering mechanisms 570, 572 may cause the tip 530 to change shape (e.g., change from a straight shape to a bent or curved shape) or change direction or orientation (e.g., point to one side or another). Many other types of steering mechanisms, systems, devices and the like may be used with any of the surgical devices disclosed herein. For example, a handheld mechanical or electronically operated trigger member may be used to actuate the steering mechanisms 570, 572. The steering mechanism are typically operable from outside of a body cavity to remotely reposition a distal end portion of the surgical device, or change a shape thereof, to help navigate the surgical device through body passages and cavities.
The distal end portion 528, or portions thereof, of surgical device 500 may include malleable materials or have malleable properties. The malleable properties of distal end portion 528 may provide at least some automatic or self-initiated change of orientation or shape of the surgical device while navigating through the body. The surgical device 500 may include a distal end portion 528 that is both malleable and steerable.
Advantageously, the surgical devices disclosed herein are able to provide suction without the suction openings being obstructed, as well as cauterization using a desirable bipolar cautery system in a single device. The surgical devices disclosed herein provide a generally lower cost option for treating sinus bleeds in difficult to reach areas. The relatively low cost of the surgical devices disclosed herein may make it possible for the surgical devices to be disposable after a single use. The surgical devices disclosed herein are generally easier to manipulate and operate as part of performing a cauterization procedure within the sinuses and other difficult to reach areas of the body. The surgical devices disclosed herein may provide additional precision in treating tissue at a treatment site. The added precision may address concerns related to potential unnecessary damage that may occur when treating enflamed, bleeding, infected and other sensitive tissue and/or conditions at a treatment site. The precision and/or accuracy may be associated with the construction of the distal end portion of the surgical device, which may include malleable and steerable properties and the potential ability to customize the cauterization zone and/or intensity provided by the plurality of bipolar wires.
The preceding description has been presented only to illustrate and describe exemplary embodiments of invention. It is not intended to be exhaustive or to limit the invention to any precise form disclosed. Many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention be defined by the following claims.

## Claims

1. A coagulation suction device, comprising:
a hollow suction tube, comprising:
a closed distal tip having a radius of curvature;
a proximal open end;
at least one suction opening positioned proximal of the closed distal tip;
wherein a position of the closed distal tip is adjustable relative to remaining portions of the hollow suction tube;

at least first and second bipolar wires extending along the hollow suction tube to the closed distal tip, the at least first and second bipolar wires each having an exposed distal end, the first and second bipolar wires extending distally no further than a distal-most surface of the closed distal tip, and the exposed distal ends of the first and second bipolar wires bend toward each other at the closed distal tip and follow the radius of curvature of the closed distal tip;
an insulation cover encapsulating the at least first and second bipolar wires along a length of the at least first and second bipolar wires and terminating proximal of the exposed distal ends of the first and second bipolar wires.

2. The coagulation suction device of claim 1, wherein the insulation cover terminates proximal of the at least one suction opening.

3. The coagulation suction device of claim 1, wherein the at least one suction opening comprises at least first and second suction openings.

4. The coagulation suction device of claim 3, wherein the at least first and second suction openings are arranged opposite each other around a circumference of the hollow suction tube.

5. The coagulation suction device of claim 1, wherein the at least one suction opening includes an oblong shape.

6. The coagulation suction device of claim 1, wherein the at least first and second bipolar wires are positioned on opposite sides of each other around a circumference of the hollow suction tube.

7. The coagulation suction device of claim 1, further comprising a suction control device positioned at a proximal end portion of the hollow suction tube.

8. The coagulation suction device of claim 7, wherein the suction control device includes a thumb actuated suction opening in flow communication with an interior of the hollow suction tube.

9. The coagulation suction device of claim 1, further comprising a suction tubing attachment device positioned at the proximal open end of the hollow suction tube.

10. The coagulation suction device of claim 1, further comprising a bipolar plug positioned at a proximal end of the at least first and second bipolar wires.

11. The coagulation suction device of claim 1, wherein the distal ends of the at least first and second bipolar wires are exposed along a distal end surface of the closed distal tip of the hollow suction tube.

12. The coagulation suction device of claim 1, wherein the hollow suction tube comprises a malleable material to provide adjustability of the closed distal tip relative to remaining portions of the hollow suction tube.

13. The coagulation suction device of claim 1, wherein the hollow suction tube and the insulation cover comprise polymer materials.

14. The coagulation suction device of claim 1, wherein the insulation cover encapsulates the hollow suction tube proximally along at least a portion of a length of the hollow suction tube from a location proximal of the at least one suction opening.

15. A coagulation suction device, comprising:
a hollow suction tube, comprising:
a closed distal tip located at a distal end portion of the hollow suction tube and having a radius of curvature;
a malleable portion to provide self-adjustment of an orientation of the closed distal tip internal a body cavity;

a plurality of bipolar wires extending distally no further than the closed distal tip of the hollow suction tube, the plurality of bipolar wires extending toward each other at the closed distal tip and following the radius of curvature of the closed distal tip;
at least one suction opening formed in the hollow suction tube at the distal end portion at a location proximal of the closed distal tip;
an insulation cover encapsulating the plurality of bipolar wires and hollow suction tube to a location proximal of the at least one suction opening.

16. The coagulation suction device of claim 15, further comprising a suction control member positioned at a proximal end portion of the hollow suction tube and operable to control suction forces available at the at least one suction opening.

17. The coagulation suction device of claim 15, wherein the at least one suction opening includes a plurality of suction openings.

18. The coagulation suction device of claim 15, wherein the closed distal tip of the hollow suction tube defines a hemispherical shape distal end surface of the hollow suction tube.

19. The coagulation suction device of claim 15, further comprising a tip control mechanism operable to control an orientation of the closed distal tip from external the patient while the closed distal tip is located within the body cavity of the patient.

20. A method of manufacturing a coagulation suction device, comprising:
providing a hollow suction tube, a plurality of bipolar wires, and an insulation cover;
closing a distal tip of the hollow suction tube;
forming at least one suction opening in a distal end portion of the hollow suction tube at a location proximal of the closed distal tip;
arranging the plurality of bipolar wires directly adjacent to and extending along a length of the hollow suction tube to the closed distal tip;
encapsulating portions of the plurality of bipolar wires with the insulation cover, the insulation cover being arranged so that the distal ends of the plurality of bipolar wires, the closed distal tip of the hollow suction tube, and the at least one suction opening are exposed distal of the insulation cover, the plurality of bipolar wires extending distally no further than a distal-most surface of the closed distal tip, and the distal ends of the plurality of bipolar wires bend toward each other at the closed distal tip and follow a radius of curvature of the closed distal tip.