# Patent

## Title
Fluid-assisted medical devices and methods

## Abstract

A bipolar electrosurgical scraper device is provided comprising a handle, a blade having a thickness and a beveled distal end with the beveled distal end terminating distally in a scraping edge. The beveled distal end includes a first electrode and a second electrode with the first electrode and the second electrode provided along a width of the blade and spaced apart with respect to the thickness of the blade. The device also comprises a fluid passage at least one fluid outlet in fluid communication with the fluid passage.

## Background
This application is a divisional of U.S. application Ser. No. 11/051,090 filed Feb. 4, 2005, now U.S. Pat. No. 7,727,232, which application claims priority to U.S. provisional application Ser. No. 60/541,997, filed Feb. 4, 2004, the entire disclosure of which is incorporated herein by reference.


FIELD
This invention relates generally to the field of medical devices and methods for use upon a body during surgery. More particularly, the invention relates to electrosurgical devices, systems and methods for use upon tissues of a human body during surgery, particularly open surgery.
BACKGROUND
The human spinal column is composed of bone vertebrae which support the upper body. Around and attached to the vertebrae are, among other things, various muscles which act on the vertebrae to affect movement of the upper body. While a vast majority of the population has a normally shaped spinal column, a portion of the population suffers from an abnormal curvature of the spinal column known as scoliosis.
Scoliosis is treated by fusing various vertebrae together along the curvature to straighten the spine column. During a fusion procedure, the surgeon first retracts the soft tissue connected to the vertebrae to be fused, and thereafter removes certain of the processes (bone projections) from the vertebrae. The vertebrae are then aligned to straighten the spinal column, and stabilized relative to one another by a steel rod which is attached to the vertebrae by numerous fastening techniques. The surgeon then places bone graphs across the exposed surfaces of adjoining vertebrae and restores the location of the soft tissue to cover the bone graphs and vertebrae. The graphs regenerate, grow into bone and fuse the vertebrae together, with the rod functioning as a temporary splint which stabilizes the spinal column while the bone fuses together over a period of months.
Fusion procedures to treat scoliosis generally take many hours. In some cases, the entire length of the spinal column is substantially exposed and the surgical procedure may take eight hours or more. Consequently, blood loss during the procedure can be significant. A great amount of this blood loss occurs when the soft tissue is removed from the vertebrae, generally with a device that scrapes along the hard vertebrae surface and simultaneously strips the soft tissue from the vertebrae. Generally the soft tissue is first removed from the vertebrae with a first handheld non-powered instrument, and then the separated tissue is treated to reduce blood loss with a second instrument, typically an electrosurgical monopolar (Bovie) pencil. What is needed is a single surgical instrument which reduces the need to switch between different instruments, and offers the surgeon the ability to treat tissue against blood loss simultaneously with the separation of soft tissue from bone, resulting in reduced surgical time.
SUMMARY OF THE INVENTION
According to one aspect of the present invention, a bipolar electrosurgical scraper device is provided comprising a handle, a blade having a thickness and a beveled distal end with the beveled distal end terminating distally in a scraping edge. The beveled distal end includes a first electrode and a second electrode with the first electrode and the second electrode provided along a width of the blade and spaced apart with respect to the thickness of the blade. The device also comprises a fluid passage and at least one fluid outlet in fluid communication with the fluid passage.
According to another aspect of the present invention, a bipolar electrosurgical scraper device is provided comprising a handle, a blade having a thickness and a beveled distal end with the beveled distal end terminating distally in a scraping edge. The beveled distal end includes a first electrode and a second electrode with the first electrode and the second electrode comprising two strips along a width of the blade and spaced apart with respect to the thickness of the blade. The device also comprises a fluid passage and at least one fluid outlet in fluid communication with the fluid passage.
According to one aspect of the invention, the scraping edge of the device may be straight or curved, and in particular semi-circular.
According to another aspect of the invention, the first electrode and the second electrode may be provided along a center portion of the width of the blade, along a substantial portion of the width of the blade or along the complete width of the blade.
According to another aspect of the invention, the beveled distal end is at a bevel angle with respect to a longitudinal axis of the device, and the bevel angle may be in the range between and including about 20 degrees to 70 degrees, in the range between and including about 30 degrees to 60 degrees or 30 degrees.
According to another aspect of the invention, the blade further comprises a front side and a back side, the beveled distal end is at a bevel angle with respect to a longitudinal axis of the device and the bevel angle is uniform from the front side to the back side of the blade.
According to another aspect of the invention, the beveled distal end is at a bevel angle with respect to a longitudinal axis of the device; and the bevel angle is uniform along the thickness of the blade.
According to another aspect of the invention, the beveled distal end comprises an electrical insulator with the electrical insulator located between the first electrode and the second electrode.
According to another aspect of the invention, the blade comprises a layered structure with respect to the thickness of the blade, the layered structure comprising an intermediate insulating member disposed between a first metal member and a second metal member, with the first metal member serving as the first electrode, the second metal member serving as the second electrode and one of the first metal member and second metal member providing the scraping edge.



BRIEF DESCRIPTION OF THE DRAWINGS
To better understand and appreciate the invention, reference is made to the following detailed description in connection with the accompanying drawings, hand and/or computer generated:
FIG. 1 is a perspective view of an electrosurgical device according to the present invention;
FIG. 2 is front view of the device of FIG. 1;
FIG. 3 is a rear view of the device of FIG. 1;
FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. 2;
FIG. 5 is a close-up of the tip portion within the circle of FIG. 4;
FIG. 6 is an alternative embodiment of the tip portion;
FIG. 7 is an exploded close-up perspective view of the tip portion;
FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. 2;
FIG. 9 is a side view of the tip portion;
FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. 9;
FIG. 11 is a block diagram of an electrosurgical system used with device of FIG. 1; and
FIG. 12 is a close-up cross-sectional view of the tip portion in the presence of tissue; and
FIG. 13 is a side view of the tip portion being used to remove tissue from a human vertebrae.



DETAILED DESCRIPTION
Throughout the present description, like reference numerals and letters indicate corresponding structure throughout the several views, and such corresponding structure need not be separately discussed. Furthermore, any particular feature(s) of a particular exemplary embodiment may be equally applied to any other exemplary embodiment(s) of this specification as suitable. In other words, features between the various exemplary embodiments described herein are interchangeable as suitable, and not exclusive.
Reference will now be made to the preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the preferred embodiments of the invention describe medical devices and methods of use, it should be understood that their combination is for purposes of illustration only. In other words, it should be understood that the use of the medical devices of the present invention is not limited to any methods disclosed herein. Conversely, it should be equally understood that the methods of the present invention can potentially be used with a wide variety of medical devices.
An exemplary electrosurgical device of the present invention is shown at reference character 10 throughout the figures. As shown in FIG. 1, electrosurgical device 10 more specifically comprises a fluid-assisted bipolar electrosurgical device. With a bipolar device, in the presence of alternating current, an electrical circuit is created with the electrodes of the device, which alternate in polarity between positive and negative charges with the current flow from the positive to the negative charge.
As shown in FIGS. 2 and 3, electrosurgical device 10 has a working tip portion 12 and a handle 16 for grasping device 10 and manipulating tip portion 12. As shown in FIG. 4, handle 16 preferably includes a cylindrical hand grip member 18 which has an electrically insulative material, such as a synthetic polymer, overlying a support (reinforcement) arm 14. Support arm 14 preferably comprises a hollow metal cylinder provided, for example, by stainless steel tubing having a substantially uniform diameter along its length. Support arm 14 and hand grip member 18 are interconnected by having at least a portion of support arm 14 inserted into a bore 22 in hand grip member 18. In the embodiment shown, hand grip member 18 completely covers arm 14, but in other embodiments only a portion of arm 14 may be covered, such as only a proximal portion. Also, in other embodiments, support arm 14 may be deleted.
As best seen in FIGS. 2 and 4, tip portion 12 is blade shaped and comprises a front-side 28 and a rear-side 30, and flanking (lateral) left-side 32 and right-side 34. As best seen in FIG. 5, front-side 28 has a front-side planar surface 36 which is parallel with rear-side planar surface 38. At the distal end of device 10, the transition between front-side surface 36 and rear-side surface 38 includes a bevel surface 40, which forms a bevel angle A with rear-side surface 38.
Preferably, bevel angle A should be in the range between and including about 10 degrees to 80 degrees, and more preferably in the range between and including about 20 degrees to 70 degrees. Even more preferably, bevel angle A should be in the range between and including about 30 degrees to 60 degrees. As shown in this embodiment, bevel angle A is 30 degrees.
Also best shown in FIG. 5, rear-side surface 38 and bevel surface 40 extend distally to a distal leading sharp scraping/cutting edge 42. Referring back to FIG. 3, leading edge 42 is preferably curved (e.g., semi-circular) outwardly along the width W of tip portion 12 with respect to the length L of device 10. In other embodiments, as shown in FIG. 6, leading edge 42 may be straight as opposed to curved.
Tip portion 12 has a width W preferably in the range of 0.125 inch (3 mm) to 1 inch (25 mm), with the preferred width W depending notably on the size of the treatment site and the ability to successfully navigate within the treatment site. Device 10 may be provided as part of a kit including devices 10 having varying widths, either based on a metric units (e.g. 3 mm, 4 mm, 5 mm, . . . 25 mm) or standard (English) units (e.g. 1⁄8 inch, 1⁄4 inch, 1⁄2 inch, 5⁄8 inch, 3⁄4 inch, 1 inch).
As best shown in FIG. 7, tip portion 12 comprises an electrode support member 44, which comprises an electrically insulative material, preferably a polymer and more preferably a fluorinated polymer such as polytetrafluoroethylene (PTFE). In addition to functioning as a electrical insulator, polytetrafluoroethylene is preferred because it is hydrophobic and thus inhibits fluids present during surgery from settling thereon, provides good arc resistance, and provides a low coefficient of friction for reduced tissue sticking.
As shown in FIG. 7, support member 44 provides an intermediate support pedestal 46 positioned in a sandwich type layered structure between two metal blade shaped electrodes 48a, 48b which are electrically coupled to an energy source such as a generator. Electrodes 48a, 48b provide a portion of front-side surface 36 and rear-side surface 38, respectively. Also as shown, the distal end surfaces 50a, 50b of electrodes 48a, 48b and the distal end surface 52 of support member 44 all provide a portion of bevel surface 40.
Continuing with FIG. 7, the distal end surfaces 50a, 50b of electrodes 48a, 48b and the distal end surface 52 of support member 44 are preferably all provided such that bevel surface 40 is substantially planar along its length from rear-side surface 38 to front-side surface 36. As best shown in FIG. 5, electrodes 48a, 48b and support member 44 all preferably individually have a bevel angles which are each equal to bevel angle A, thus maintaining a uniform bevel angle through the thickness T of tip portion 12 from rear-side surface 38 to front-side surface 36.
As shown in FIG. 8, preferably electrodes 48a, 48b are assembled to support member 44 by means of an interlocking joint which provides mechanical engagement between the pieces and restricts their separation, and also assists positioning the pieces relative to one another. As shown, preferably each electrode 48a, 48b is formed with a pair of elongated, parallel, longitudinally oriented flared tenons 54a, 54b which slide in proximally and cooperate with a pair of elongated, parallel undercut mortises 56a, 56b formed in support member 44 which results in a dovetail joint when assembled. With this configuration, a mechanical engagement which restricts the layers from planar separation is created between the flared portion 58a, 58b of tenons 54a, 54b and undercut portions 60a, 60b of mortises 56a, 56b. 
As best shown in FIG. 7, the flared tenons 54a, 54b of each electrode 48a, 48b are configured to slide proximally into the undercut mortises 56a, 56b formed in support member 44 until a center span portion 62a, 62b of each electrode 48a, 48b makes contact with a shoulder 64a, 64b. After electrodes 48a, 48b have been assembled to support member 44, a proximal portion 66 of the working tip assembly 68 is inserted into rectangular receptacle 70 of tip assembly housing 72.
As shown in FIGS. 9 and 10, proximal portion 66 of tip assembly 68 extends into receptacle 70 provided by a portion of cavity 73 such that the proximal end 74 of tip assembly 68 is positioned against shoulder 76 of housing 72. In order to inhibit the separation of tip assembly 68 from housing 72, preferably the proximal portion 66 of tip assembly 68 is press (interference) fit into receptacle 70.
As best shown in FIGS. 5, support arm 14 is preferably assembled to tip assembly housing 72 by inserting a distal portion 78 of support arm 14 into circular receptacle 80. As shown, distal portion 78 of arm 14 extends into receptacle 80 such that the distal end 82 of arm 14 is positioned against shoulder 84 of housing 72. In order to inhibit the separation of arm 14 from housing 72, preferably the distal portion 78 of arm 14 is press (interference) fit into receptacle 80.
As shown in FIG. 11, electrosurgical device 10 is preferably used as part of a system 110 comprising a fluid source 112 and an electrical energy source 114. As shown, electrosurgical device 10 is preferably coupled to energy source 114 via insulated wire conductors 86a, 86b. With respect to the fluid coupling, fluid 116 from the fluid source 112 is preferably communicated from fluid source 112 to electrosurgical device 10 through a flexible, polyvinylchloride (PVC) fluid line 88 having a fluid passage (lumen) 90.
Energy source 114 preferably comprises a generator, and more preferably a radio frequency alternating current generator which may provide radio frequency power therefrom at selected increments. Fluid source 112 preferably comprises an intravenous bag containing electrically conductive fluid, which more preferably comprises saline. More preferably, the saline comprises sterile, and even more preferably, normal saline. Although the description herein will specifically describe the use of saline as the fluid, other electrically conductive fluids, as well as non-conductive fluids, can be used in accordance with the invention.
For example, in addition to the conductive fluid comprising physiologic saline (also known as “normal” saline, isotonic saline or 0.9% sodium chloride (NaCl) solution), the conductive fluid may comprise hypertonic saline solution, hypotonic saline solution, Ringers solution (a physiologic solution of distilled water containing specified amounts of sodium chloride, calcium chloride, and potassium chloride), lactated Ringer's solution (a crystalloid electrolyte sterile solution of distilled water containing specified amounts of calcium chloride, potassium chloride, sodium chloride, and sodium lactate), Locke-Ringer's solution (a buffered isotonic solution of distilled water containing specified amounts of sodium chloride, potassium chloride, calcium chloride, sodium bicarbonate, magnesium chloride, and dextrose), or any other electrolyte solution. In other words, a solution that conducts electricity via an electrolyte, a substance (salt, acid or base) that dissociates into electrically charged ions when dissolved in a solvent, such as water, resulting solution comprising an ionic conductor.
As best shown in FIG. 5, a distal portion 89 of fluid line 88 is preferably interference fit over the outside diameter of a proximal portion 91 of a hollow coupling tube 92 to provide a press fit seal there between. A distal portion 93 of coupling tube 92 is inserted and interference fit in a distally extending bore 94 within support member 44. Fluid 116 from fluid passage 90 of fluid line 88 flows therefrom into fluid passage 96 of coupling tube 92 and thereafter into fluid passage 98 provided by bore 94 where is finally expelled from fluid outlet opening 100 in top side 28.
As shown in FIG. 11, radio frequency energy for electrodes 48a, 48b is provided from electrical energy source 114 through insulated wire conductors 86a, 86b. Preferably, wire conductors 86a, 86b reach electrodes 48a, 48b by traveling through bore 20 of arm 14 and thereafter through cavity 73 of housing 72. As shown in FIG. 7, wire conductors 86a, 86b are electrically coupled (e.g. welded) to electrodes 48a, 48b, and connectable to energy source 114 via two connectors 102a, 102b (such as banana (male) plug connectors) as shown in FIG. 1.
As best shown in FIG. 12, when device 10 is in use as a sealer to inhibit bleeding, electrodes 48a, 48b are preferably positioned adjacent tissue surface 118 of tissue 120. As shown, the electrodes 48a, 48b are fluidly coupled to the surface 118 of tissue 120 by a fluid coupling 122 which provides a film of fluid 116 between surface 118 of tissue 120 and bevel surface 40 of device 10. When the user of electrosurgical device 10 places electrodes 48a, 48b at a tissue treatment site and moves electrodes 48a, 48b across surface 118 of tissue 120, fluid 116 is being expelled from outlet opening 100 and at the same time, radio frequency electrical energy (current), as shown by electrical field lines 124, is provided to tissue 120 at tissue surface 118 and below tissue surface 118 into tissue 120 through the fluid coupling 122.
In addition to fluid 116 providing an electrical coupling between the electrosurgical device 10 and tissue 120, fluid 116 lubricates surface 118 of tissue 120 and facilitates the movement of electrodes 48a, 48b across surface 118 of tissue 120. During movement of electrodes 48a, 48b, electrodes 48a, 48b typically slide across the surface 118 of tissue 120. Typically the user of electrosurgical device 10 slides electrodes 48a, 48b across surface 118 of tissue 120 by moving device 10 with repetitive strokes, while using fluid 116 as, among other things, a lubricating coating. Preferably the thickness of the fluid 116 between the electrodes 48a, 48b and surface 118 of tissue 120 is in the range between and including about 0.05 mm to 1.5 mm, and more preferably in the range between and including about 0.1 mm to 0.3 mm. In certain embodiments, the electrodes 48a, 48b may contact surface 118 of tissue 120 without any fluid 116 in between.
With use of electrosurgical device 10, the heating of the tissue 120 is generated due to the electrical resistance of the tissue 120. In other words, increasing the temperature of the tissue 120 as a result of electric current flow through the tissue 120, with the electrical energy being absorbed from the voltage and transformed into thermal energy (i.e. heat) via accelerated movement of ions as a function of the tissue's electrical resistance.
Device 10 is particularly useful to a surgeon as a tissue coagulator and sealer which seals tissue from the flow of bodily fluids (e.g. blood) by shrinking the tissue. As known in the art, when exposed to heat, the collagen of the blood vessels will shrink, thus decreasing the diameter and associated lumen of the vessel. With use of device 10, certain vessels, depending on size and proximity to surface of tissue will become completely occluded, while other vessels, such as deep or particularly large vessels, may become only partially occluded initially, and need additional treatment with device 10 to become completely occluded as the device 10 is used to coag and cut deeper into the tissue. During use, device 10 can be moved over a raw (untreated), oozing surface of tissue to seal the tissue against bleeding, or focused on individual large vessels, such as to seal a bleeding vessel which has been cut, or to occlude a vessel prior to being cut.
With its wedge/chisel shape, device 10 is also particularly useful as a tissue cutter and separator to separate tissue adjacent bone (e.g. connective tissue such as muscle, tendons, ligaments and periosteum) with a wedge technique, and seal the tissue which has been separated from the bone. In a spine procedure, for example, such as a device 10 may be used to separate soft tissue from the vertebrae of the spine. More specifically, device 10 may be used to separate soft tissue from the various portions of the vertebrae, such as the vertebral arch, vertebral body, various processes (e.g. spinous process, transverse process, annular process, inferior articular process, superior articular process) and various facets (superior articular facet, inferior articular facet).
As shown in FIG. 13, as part of an osteotomy of the spine to correct a spinal deformity resulting from, for example, scoliosis, device 10 separates erector spinae muscle 126 from the spinous process 128 of the vertebrae 130 by cutting the periosteum 132 and wedging device 10 between the erector spinae muscle 126 and the spinous process 128 while simultaneously using device 10 as a retractor against erector spinae muscle 126 and sealing the severed periosteum 132 against blood loss.
In other embodiments, electrosurgical device 10 may comprise a single electrode 48 and be a monopolar device. With use of a monopolar device, the first electrode, often referred to as the active electrode, comprises electrode 48 of the electrosurgical device 10 while a second electrode, often referred to as the indifferent or return electrode, comprises a ground pad dispersive electrode located on the patient and coupled to energy source 114, typically on the back or other suitable anatomical location. An electrical circuit is formed between electrode 48 and ground pad dispersive electrode with electrical current flowing from electrode 48 through the patient to ground pad dispersive electrode in a manner known in the art.
While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications can be made therein without departing from the spirit of the invention and the scope of the appended claims. The scope of the invention should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims along with their full scope of equivalents.
Furthermore, it should be understood that the appended claims do not necessarily comprise the broadest scope of the invention which the Applicant is entitled to claim, or the only manner(s) in which the invention may be claimed, or that all recited features are necessary.
All publications and patent documents cited in this application are incorporated by reference in their entirety for all purposes, to the extent they are consistent.

## Claims

1. A bipolar electrosurgical scraper device comprising:
a handle;
a blade distal to the handle, the blade having a front side, a rear side, a thickness and a beveled distal end, the beveled distal end terminating distally in a curved scraping edge at a rear side of the blade;
the beveled distal end including a first electrode and a second electrode, the first electrode and the second electrode provided along a width of the blade and spaced apart with respect to the thickness of the blade, wherein the beveled distal end is at a bevel angle with respect to a longitudinal axis of the device, and wherein the bevel angle is uniform along the thickness of the blade;
a fluid passage extending distally with the handle; and
at least one fluid outlet in fluid communication with the fluid passage.

2. The device of claim 1 wherein:
the scraping edge is semi-circular.

3. The device of claim 1 wherein:
the first electrode and the second electrode are provided along a center portion of the width of the blade.

4. The device of claim 1 wherein:
the first electrode and the second electrode are provided along a substantial portion of the width of the blade.

5. The device of claim 1 wherein:
at least one of the first electrode and the second electrode are provided along a complete width of the blade.

6. The device of claim 1 wherein:
the bevel angle in the range between and including about 20 degrees to 70 degrees.

7. The device of claim 1 wherein:
the bevel angle in the range between and including about 30 degrees to 60 degrees.

8. The device of claim 1 wherein:
the bevel angle is uniform from the front side to the rear side of the blade.

9. The device of claim 1 wherein:
the beveled distal end further comprises an electrical insulator, the electrical insulator located between the first electrode and the second electrode.

10. The device of claim 9 wherein:
the electrical insulator comprises a polymer.

11. The device of claim 1 wherein:
the blade further comprises a layered structure with respect to the thickness of the blade, the layered structure comprising an intermediate insulating member disposed between the first electrode and the second electrode.

12. The device of claim 11 wherein:
one of the first electrode and second electrode provides the scraping edge.

13. The device of claim 11 wherein:
the layered structure is restricted from separation by a dovetail joint.

14. A bipolar electrosurgical scraper device comprising:
a handle;
a blade distal to the handle, the blade having a front side, a rear side, a thickness and a beveled distal end, the beveled distal end terminating distally in a scraping edge at a rear side of the blade;
the beveled distal end including a first electrode and a second electrode, the first electrode and the second electrode provided along a width of the blade and spaced apart with respect to the thickness of the blade, wherein the beveled distal end is at a bevel angle with respect to a longitudinal axis of the device, and wherein the bevel angle is uniform along the thickness of the blade, and wherein at least one of the first electrode and the second electrode is provided along a complete width of the blade;
a fluid passage extending distally with the handle; and
at least one fluid outlet in fluid communication with the fluid passage.

15. The device of claim 14 wherein:
the scraping edge is curved.

16. The device of claim 14 wherein:
the scraping edge is semi-circular.

17. The device of claim 14 wherein:
the bevel angle in the range between and including about 20 degrees to 70 degrees.

18. The device of claim 14 wherein:
the bevel angle in the range between and including about 30 degrees to 60 degrees.

19. The device of claim 14 wherein:
the bevel angle is uniform from the front side to the rear side of the blade.

20. The device of claim 14 wherein:
the beveled distal end further comprises an electrical insulator, the electrical insulator located between the first electrode and the second electrode.

21. The device of claim 14 wherein:
the blade further comprises a layered structure with respect to the thickness of the blade, the layered structure comprising an intermediate insulating member disposed between the first electrode and the second electrode.

22. The device of claim 14 wherein:
one of the first electrode and second electrode provides the scraping edge.

23. The device of claim 21 wherein:
the layered structure is restricted from separation by a dovetail joint.