US20150327919A1

US20150327919A1 - Apparatus and Method for Treating Disorders of the Ear, Nose and Throat

Info

Publication number: US20150327919A1
Application number: US14/699,169
Authority: US
Inventors: Mathew D. Clopp; Randy J. Kesten; Howard L. Levine
Original assignee: Acclarent Inc
Current assignee: Acclarent Inc
Priority date: 2014-05-13
Filing date: 2015-04-29
Publication date: 2015-11-19
Also published as: WO2015175176A1; WO2015175177A2; EP3142575A1; US20150327880A1; US10179002B2; WO2015175177A3

Abstract

Apparatus for use in surgeries to treat disorders of the ear, nose, and throat including a hand-held device and rotating blade assembly. The apparatus may be connected to a vacuum source. A method of use is also disclosed.

Description

Cross-reference is made to co-pending U.S. Patent App. Ser. No. 61/992,596, entitled “APPARATUS AND METHOD FOR TREATING DISORDERS OF THE EAR, NOSE, AND THROAT,” which was filed on May 13, 2014 and is expressly incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates generally to surgical instruments and methods and, more particularly, to surgical instruments for use in surgeries to treat disorders of the ear, nose, and throat.

BACKGROUND

Functional endoscopic sinus surgery (FESS) is a common type of surgery used to treat chronic sinusitis, as well as remove tumors, polyps and other aberrant growths from the nose. In a typical FESS procedure, an endoscope is inserted into the nostril along with one or more surgical instruments. The endoscope typically provides the surgeon with a direct line-of-sight view to permit the surgeon to visualize a number of relevant anatomical structures within the surgical field. Under visualization through the endoscope, the surgeon may remove diseased or hypertrophic tissue or bone and/or enlarge the ostia of the sinuses to restore normal drainage of the sinuses. A number of surgical instruments may be used to cut and remove tissue and/or bone, cauterize, suction, etc. during a FESS procedure.
Nasal polyp surgery is one type of FESS procedure that is typically performed in an operating room with the patient under general anesthesia. It typically involves a powered fixed piece of capital equipment that includes a console and a hand piece. This equipment usually requires electrical, vacuum, and saline hookups. This surgical method is highly invasive and requires substantial recovery time for the patient
Nasal polyps can also be removed in the physician's office with simple tools such as forceps. The patient is typically awake during the procedure. The physician is limited by what he can comfortably reach and remove without creating too much discomfort to the patient. This procedure is relatively limited in the ability to remove substantial nasal polyps.
Another removal tool is a microdebrider, which is a rotary cutting tool that may be used to shave tissue and/or bone. Microdebriders may be connected to a vacuum source, which may be used to create suction that remove excess blood and tissue from the surgical field.

SUMMARY

According to one aspect of the disclosure, a surgical instrument is disclosed. The instrument includes an electrical power source configured to generate an alternating current, a hand piece configured to be coupled to the electrical power source, an outer shaft extending distally from the hand piece, a first inner shaft positioned in the outer shaft, and a second inner shaft positioned in the outer shaft. The outer shaft has a slot defined in a distal end. The first inner shaft is configured to rotate relative to the slot in a first direction. The second inner shaft is configured to rotate relative to the slot in a second direction opposite the first direction. The first inner shaft is electrically connected to the electrical power source, the second inner shaft is electrically conductive, and the first inner shaft is electrically isolated from the second inner shaft.
In some embodiments, the first inner shaft may include a first plurality of splines that are aligned axially with the slot, and the second inner shaft may include a second plurality of splines that are interdigitated with the first plurality of splines of the first inner shaft.
In some embodiments, the outer shaft may have a passageway defined therein. The passageway may be configured to be fluidly coupled to a negative pressure source.
In some embodiments, the distal end of the outer shaft may be formed from a non-conductive material. In some embodiments, the outer shaft may include a first plurality of cutting teeth that partially define the slot at the distal end.
Additionally, in some embodiments, the first inner shaft may include a second plurality of cutting teeth aligned axially with the first plurality of cutting teeth.
In some embodiments, the first inner shaft may include a passageway, and the first plurality of cutting teeth and the second plurality of cutting teeth may be configured to cooperate to cut tissue advanced into the passageway through the slot. Additionally, in some embodiments, the outer shaft may include a third plurality of cutting teeth that partially define a second slot in the distal end, and the second inner shaft may include a fourth plurality of cutting teeth that are aligned axially with the third plurality of cutting teeth.
In some embodiments, the second inner shaft may include a second passageway, and the third plurality of cutting teeth and the fourth plurality of cutting teeth may be configured to cooperate to cut tissue advanced into the second passageway through the slot.
In some embodiments, the hand piece may include a negative pressure source connector configured to be coupled to a negative pressure source to fluidly connect the outer shaft to the negative pressure source.
The surgical instrument may also include a drive mechanism configured to rotate the first inner shaft and the second inner shaft relative to the outer shaft. In some embodiments, the drive mechanism may include an electric motor positioned in the hand piece.
In some embodiments, the electrical power source may be configured to generate a radio frequency electric current. In some embodiments, the outer shaft may have a rounded, convex distal surface. In some embodiments, the second inner shaft may be electrically connected to the electrical power source. In some embodiments, the distal end of the outer shaft is formed from an electrically-conductive material.
According to another aspect, a method of performing a surgical procedure is disclosed. The method includes advancing a distal end of a surgical instrument into a cavity of a patient, activating the surgical instrument to rotate a first inner shaft in a first direction within an outer shaft and rotate a second inner shaft in a second direction opposite the first direction within the outer shaft, and advancing the first inner shaft and the second inner shaft into contact with a portion of the patient's tissue in the cavity such that the patient's tissue contacting the first inner shaft and the second inner shaft completes an electrical circuit and electrical current flows through the portion of the patient's tissue. In some embodiments, activating the surgical instrument may include generating negative pressure to draw the portion of the patient's tissue into a passageway defined in the surgical instrument.
In some embodiments, advancing the first inner shaft and the second inner shaft into contact with the portion of the patient's tissue may include pinching the portion of the patient's tissue between a plurality of splines.
In some embodiments, advancing the first inner shaft and the second inner shaft into contact with the portion of the patient's tissue may include engaging a first plurality of cutting teeth of the first inner shaft with the portion of the patient's tissue, and engaging a second plurality of cutting teeth of the second inner shaft with the portion of the patient's tissue.
In some embodiments, advancing the first inner shaft and the second inner shaft into contact with the portion of the patient's tissue may further include engaging a set of cutting teeth of the outer shaft with the portion of the patient's tissue.
In some embodiments, the electrical circuit may include the outer shaft.
In some embodiments, the first inner shaft may be isolated electrically from the second inner shaft until advanced into contact with the patient's tissue.
According to another aspect, the surgical instrument includes a hand piece, an outer shaft coupled to the hand piece that extends to a distal end, and a hub including a barb that extends outwardly from a depressible outer wall. The depressible outer wall is movable between a first position in which the barb is engaged with the hand piece to secure the outer shaft to the hand piece and a second position in which the barb is disengaged from the hand piece to permit the outer shaft to be detached from the hand piece. The instrument also includes an inner shaft positioned in the outer shaft. The outer shaft has a first plurality of cutting teeth defined at the distal end, and the inner shaft has a passageway and a second plurality of cutting teeth.
The surgical instrument includes a cutting slot that is partially defined by the first plurality of cutting teeth, and the inner shaft is configured to rotate relative to the outer shaft such that the first plurality of cutting teeth and the second plurality of cutting teeth cooperate to cut tissue advanced into the passageway through the cutting slot.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the following figures, in which:

FIG. 1 is an exploded perspective view of one embodiment of a surgical instrument for use in surgeries to treat disorders of the ear, nose, and throat;

FIG. 2 is a cross-sectional elevation diagrammatic view of the surgical instrument of FIG. 1;

FIG. 3 is a perspective view of another embodiment of a surgical instrument for use in surgeries to treat disorders of the ear, nose, and throat;

FIG. 4 is a partial cutaway perspective view of the distal end of the surgical instrument of FIG. 3;

FIG. 5 is a cross sectional elevation view of the surgical instrument taken along the line 5-5 in FIG. 4;

FIG. 6 is cross sectional elevation view similar to FIG. 5 showing the surgical instrument of FIG. 3 in operation;

FIG. 7 is a perspective view of a distal end of another embodiment of a surgical instrument for use in surgeries to treat disorders of the ear, nose, and throat;

FIG. 8 is a top plan diagrammatic view of the surgical instrument of FIG. 7;

FIG. 9 is a cross sectional elevation view of the surgical instrument taken along the line 9-9 in FIG. 8;

FIG. 10 is a view similar to FIG. 9 with the inner shafts of the surgical instrument rotated to another position;

FIG. 11 is a perspective view of another embodiment of a surgical instrument for use in surgeries to treat disorders of the ear, nose, and throat;

FIG. 12 is an exploded perspective view of the surgical instrument of FIG. 11;

FIG. 13 is a perspective view of another embodiment of a surgical instrument for use in surgeries to treat disorders of the ear, nose, and throat;

FIG. 14 is a perspective view of another embodiment of a surgical instrument for use in surgeries to treat disorders of the ear, nose, and throat;

FIG. 15 is a perspective view of another embodiment of a surgical instrument for use in surgeries to treat disorders of the ear, nose, and throat;

FIG. 16 is a perspective view of yet another embodiment of a surgical instrument for use in surgeries to treat disorders of the ear, nose, and throat;

FIG. 17 is a rear elevation view of the surgical instrument of FIG. 16;

FIG. 18 is a side elevation view of the surgical instrument of FIG. 16;

FIG. 19 is a plan view of one embodiment of a drive cable for the surgical instrument of FIG. 16;

FIG. 20 is a plan view of another embodiment of a drive cable for the surgical instrument of FIG. 16;

FIG. 21 is a cross section side elevation view of the drive cable of FIG. 19 taken along the line 21-21; and

FIG. 22 is a cross section side elevation view of the drive cable of FIG. 20 taken along the line 22-22.

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
Referring now to FIG. 1, a surgical instrument 10 for use in surgeries to treat disorders of the ear, nose, and throat including, for example, nasal polyp surgery is shown. The instrument 10 includes a hand piece 12 and a blade assembly 14 configured to be coupled to the hand piece 12. The blade assembly 14 includes a cutting slot 16 that is positioned at its distal end 18. In the illustrative embodiment, the surgical instrument 10 also includes a locking mechanism 20 to facilitate coupling and decoupling the blade assembly 14 to the hand piece 12, as described in greater detail below.
The hand piece 12 of the surgical instrument 10 includes an elongated body 22 and a grip 24 formed on the body 22. The grip 24 is configured to be grasped by a user during operation of the surgical instrument 10. In other embodiments, the hand piece may include a handle or may include one or more ergonomic features to facilitate use of the instrument 10. The elongated body 22 and the grip 24 may be formed from the same material such as, for example, a plastic, rigid polymer, or other rigid materials suitable for autoclaving. The grip 24 may also be formed from a soft or padded material such as neoprene. In some embodiments, the hand piece 12 may be wholly or partially covered by a disposable outer skin or wrap during surgery such that the hand piece 12 does require re-sterilization or autoclaving between surgeries. In other embodiments, the hand piece 12 may be configured to be disposable after a single-use.
The hand piece 12 includes an aperture 30 defined in a longitudinal end 32 of the elongated body 22. As shown in FIG. 1, the aperture 30 is sized to receive a proximal end 34 of the blade assembly 14. The hand piece 12 also includes a connector 36 and a connector cable 38 positioned at the opposite longitudinal end 40 of the body 22. The connector 36 and the cable 38 are configured to be coupled with corresponding connectors 42, 44 of a negative pressure source and an electrical cable 52, respectively.
The connector 42 extends from a hose 46 that is connected to a source of negative pressure such as, for example, vacuum pump 48. The connector 36 of the hand piece 12 is configured to engage the hose connector 42 such that the hand piece 12 (and hence the blade assembly 14) may be connected to the vacuum pump 48. It should be appreciated that in other embodiments the negative pressure source may take the form of an air compressor, or other suction device.
In the illustrative embodiment, the electrical cable 52 includes the connector 44, which is coupled to a power source 50 such as, for example, a standard domestic power outlet. The power source 50 is configured to supply electrical power to the hand piece 12. The cable 38 of the hand piece 12 includes a connector (not shown) that is configured to engage the connector 44. In that way, electrical power may be supplied from the source 50 to the electrically-operated components (see FIG. 2) of the hand piece 12.
As shown in FIG. 1, the hand piece 12 also includes a control panel 60 positioned on the elongated body 22. In the illustrative embodiment, the control panel 60 includes a single control button 62, which may be toggled to operate the surgical instrument 10. In other embodiments, the hand piece 12 may include additional controls such as toggles, levers, or other buttons to individually activate the electrically-operated components of the instrument 10 and/or the vacuum pump 48. It should also be appreciated that in other embodiments the control panel 60 may be omitted from the hand piece 12, and the instrument 10 and/or the vacuum pump 48 may be activated using a foot pedal or other control device.
In still other embodiments, the negative pressure source may be integrated into a portable console. Similarly, the power source may be included in a surgical console. The hand piece 12 may be configured to be plugged into a wall electrical socket via a plug or adaptor. The hand piece 12 may also be configured to be battery-powered similar to the embodiment shown in FIGS. 11-12 and described below.
The hand piece 12 includes a drive mechanism 66 that is positioned in the elongated body 22. In the illustrative embodiment, the drive mechanism 66 includes an electric motor powered by direct current (DC) and a gear assembly operable to transmit the output of the motor to the blade assembly 14. In other embodiments, the drive mechanism 66 may be powered by alternating current (AC). When the button 62 is toggled or pressed by the user, an electrical contact switch is configured to generate an electrical output, which is relayed to the pump 48 and the power source 50 via the cable 52, thereby activating the pump 48 and energizing the drive mechanism 66.
As described above, the hand piece 12 is configured to receive the blade assembly 14. In the illustrative embodiment, the hand piece 12 of the surgical instrument 10 includes a mounting collar 72, which receives the proximal end 34 of the blade assembly 14. As shown in FIG. 1, the mounting collar 72 is positioned in the aperture 30 of the hand piece 12. The mounting collar 72 illustratively includes a splined surface 74 that defines a passageway 78. When the proximal end 34 of the blade assembly 14 is seated in the aperture 30, the blade assembly 14 extends through the passageway 78 and a set of splines 76 defined on the blade assembly 14 engage the splined surface 74.
As described above, the blade assembly 14, which is the cutting tool of the surgical instrument 10, includes the inner blade shaft 90. The blade shaft 90 is positioned within an outer blade shaft 92. The cutting slot 16 is defined in the outer blade shaft 92, and the inner blade shaft 90 includes a longitudinal passageway 94 that opens into the cutting slot 16. The inner blade shaft 90 and the outer blade shaft 92 also include cutting edges 96, 98 that are axially aligned with the cutting slot 16. The edges 96, 98 are configured to cut or shaft tissue placed in the cutting slot 16 when the inner blade shaft 90 is rotated about its longitudinal axis 100. Exemplary inner blade shaft and outer blade shaft configurations are further shown and described in U.S. Patent App. Ser. No. 61/992,596, entitled “APPARATUS AND METHOD FOR TREATING DISORDERS OF THE EAR, NOSE, AND THROAT,” which was filed on May 13, 2014 and is expressly incorporated herein by reference.
As shown in FIGS. 1-2, the blade shafts 90, 92 are attached to an inner hub 110 and an outer hub 112, respectively. In the illustrative embodiment, the hubs 110, 112 are each formed from rigid material such as, for example, a metallic material, plastic, or rigid polymer. A number of gaskets or seals 114 are attached to the hubs 110, 112 to create an air-tight barrier and allow for vacuum suction.
The inner hub 110 is positioned at the proximal end 34 of the blade assembly 14 and has a longitudinal bore 116 defined therein. As shown in FIG. 2, the inner shaft 90 extends through the longitudinal bore 116. The inner hub 110 is also configured to be coupled to the drive mechanism of the hand piece 12. In that way, the inner hub 110 (and hence the inner blade shaft 90) may be rotated by the drive mechanism 66.
The outer hub 112 of the blade assembly 14 is positioned distal of the inner hub 110. The hub 112, like the inner hub 110, has a longitudinal bore 118 defined therein. As shown in FIG. 2, the outer shaft 92 extends through the longitudinal bore 118. The hub 112 also includes a cylindrical outer surface 120 and the plurality of splines 76 extend outwardly from the surface 120. As described above, the splines 76 are configured to engage the splined surface 74 of the mounting collar 72 of the hand piece 12 when the blade assembly 14 is secured thereto. In that way, the outer hub 112 is fixed relative to the hand piece 12 and hence is not rotated by the drive mechanism 66.
As described above, the surgical instrument 10 also includes a locking mechanism 20 to facilitate coupling and decoupling the blade assembly 14 to the hand piece 12. In the illustrative embodiment, the locking mechanism 20 includes a plurality of retention barbs 130 formed on the outer hub 112 and corresponding annular ring 132 formed in the mounting collar 72 of the hand piece 12. As shown in FIG. 2, the annular ring 132 is positioned distal of the splined surface 74 and extends into the aperture 30 of the hand piece 12. A recess 134, which is sized to receive the retention barbs 130, is defined between the ring 132 and the splined surface 74.
As shown in FIG. 2, the barbs 130 extend outwardly from the cylindrical outer surface 120 of the outer hub 112. Each barb 130 includes a distal surface 136 that is configured to catch or engage the annular ring 132 to secure the blade assembly 14 to the hand piece 12. Each barb 130 also includes a tapered proximal surface 138 to facilitate insertion of the blade assembly 14 into the hand piece 12, as described in greater detail below.
The outer hub 112 also includes a cylindrical grip 140 that extends outwardly from the cylindrical outer surface 120. The grip 140 is spaced apart from the barbs 130, and a channel 142 is defined between the grip 140 and the barbs 130. The channel 142 is sized to receiver the annular ring 132, as shown in FIG. 2. The grip 140 also includes a pair of knurled surfaces 144, 146 that may be gripped by the user.
As shown in FIGS. 1-2, the outer hub 112 has a pair of longitudinal slots 150, 152 that are defined in the cylindrical outer surface 120. The slots 150, 152 are spaced radially outward from the longitudinal bore 118 and are defined between a pair of planar surfaces 154. The outer hub 112 includes a pair of deflectable outer walls 156, 158, which are positioned above the slots 150, 152, respectively. As shown in FIG. 2, the barbs 130 are positioned on the outer walls 156, 158.
Each of the outer walls 156, 158 is configured to move from the undeflected position shown in FIG. 2 to a deflected position (shown by imaginary lines 160) in which the barbs 130 are moved radially inward. Each of the outer walls 156, 158 is biased in the undeflected position. The outer walls 156, 158 further possess spring-like properties that permit the walls 156, 158 to be deflected when sufficient force is applied and return to their undeflected shapes when the force is removed. It should be appreciated that in other embodiments the outer hub may include a spring or other biasing element to bias the outer walls 156, 158 in the undeflected position.
In use, the proximal end 34 of the blade assembly 14 is aligned with the aperture 30 defined in the distal end 32 of the hand piece 12. The blade assembly 14 is then advanced into the aperture 30. As the blade assembly 14 is moved along the aperture 30, the inner hub 110 is moved through the passageway 78 defined in the mounting collar 72. The blade assembly 14 may be rotated to align the splines 88 of the inner hub 110 with the slots defined in the splined surface of the hand piece 12.
As the blade assembly 14 is advanced further into the aperture 30, the tapered proximal surfaces 138 of the retention barbs 130 are advanced into contact with the annular ring 132. The engagement between the barbs 130 and the ring 132 applies a force to the outer walls 156, 158 of the outer hub 112 in the direction indicated by arrows 170. When the force is high enough to overcome the spring bias of the outer walls 156, 158, the outer walls 156, 158 deflect, thereby drawing the barbs 130 radially inward and permitting further insertion of the blade assembly 14. It should also be appreciated that a user may apply sufficient force to the knurled surfaces 144, 146 of the grip 140 to deflect the outer walls 156, 158.
The blade assembly 14 may be advanced further into the aperture to engage the splines 88 with the drive mechanism 66, thereby connecting the hub 110 with the drive mechanism 66. As the blade assembly 14 is advanced further into the aperture 30, the splines 76 of the outer hub 112 engage the splined surface 74 of the mounting collar 72, thereby fixing the outer hub 112 (and hence the outer blade shaft 92) in position relative to the hand piece 12. When the barbs 130 are advanced beyond the annular ring 132, the outer walls 156, 158 are urged outward so that the annular ring 132 is positioned in the channel 142 defined between the grip 140 and the barbs 130. In that way, the blade assembly 14 is secured to the hand piece 12 by the engagement between the barbs 130 and the annular ring 132. With the blade assembly 14 attached, a user may proceed with a surgical procedure.
To detach the blade assembly 14, a user may apply sufficient force to the knurled surfaces 144, 146 of the grip 140 to overcome the spring bias of the outer walls 156, 158. When the outer walls 156, 158 are deflected, the barbs 130 are drawn radially inward, thereby permitting removal of the blade assembly 14.
Referring now to FIGS. 3-6, another embodiment of a surgical instrument (hereinafter surgical instrument 210) is disclosed. Some of the features of the embodiment of FIGS. 3-6 are similar to the embodiment described above. For such features, the references numbers from the embodiment described above will be used to identify those features in FIGS. 3-6. As shown in FIG. 3, the instrument 210 includes a hand piece 212 and a cutting tool assembly 214 that extends outwardly from the hand piece 212 to a distal end 218. A cutting slot 216 is positioned at the closed distal end 218 of the cutting tool assembly 214. In the illustrative embodiment, the cutting tool assembly 214 is secured to the hand piece 212 and is not configured to be detached.
The instrument 210 is configured to be coupled to a power source 50 via a cable 52, which is configured to supply alternating current to the instrument 210. The instrument 210 is also configured to be coupled to a negative pressure source such as a vacuum pump 48 to evacuate the severed tissue from the instrument 210. As described above in regard to the instrument 10, the instrument 210 may include any connectors, cables, converters, or the like necessary to provide the connections between the pump 48, the power source 50, and the instrument 210.
The instrument 210 is also configured to be coupled to a radio frequency (RF) generator 220. In the illustrative embodiment, the radio frequency generator 220 may be a separate power source configured to supply alternating electrical current (AC) at radio frequencies to the cutting tool assembly 214, as described in greater detail below. In other embodiments, the RF generator may be a frequency generator that generates a low power RF signal that is combined by the instrument 210 with the electrical current generated by the power source 50 and supplied to the cutting tool assembly 214. The instrument 210 may include any connectors, cables, converters, or the like necessary to provide the connection between the instrument 210 and the radio frequency generator 220.
The hand piece 212 of the surgical instrument 210 includes an elongated body 222. The body 222 is configured to be grasped by a user during operation of the surgical instrument 210. The elongated body 222 may be formed from a plastic, rigid polymer, or other rigid materials. The hand piece 212 also includes a drive mechanism 224. In the illustrative embodiment, the drive mechanism 224 includes an electric motor powered by alternating current and a gear assembly operable to transmit the output of the motor to the cutting tool assembly 214. In other embodiments, the drive mechanism 224 may be powered by direct current.
A button 226 positioned on the body 22 may be toggled or pressed by the user to activate the pump 48 and the power source 50 and energize the drive mechanism 224. A separate button 228 positioned on the body 222 may be toggled or pressed by the user to activate the radio frequency generator 220. In other embodiments, the pump 48, the power source 50, and the generator 220 may be controlled by a single button or control located on the hand piece 212 or located external to the instrument 210 on, for example, a foot pedal.
The cutting tool assembly 214 includes a pair of inner shafts 240, 242 and an outer shaft 244 that is secured to the hand piece 212. In the illustrative embodiment, a proximal end 246 of the outer shaft 244 is press fit into a collar 248 secured to the elongated body 222 of the hand piece 212. A longitudinal passageway 250 extends from the proximal end 246 of the outer shaft 244 to cutting slot 216 at the closed distal end 218. The passageway 250 is connected to the vacuum pump 48 such that negative pressure may be created through the longitudinal passageway 250 to draw severed tissue from the distal end 218 of the cutting tool assembly 214, through the hand piece 212, and out of the instrument 210.
Referring now to FIG. 4, the cutting slot 216 includes a rectangular opening 252 that is defined in the cylindrical outer surface 254 of the outer shaft 244. The inner shaft 240 has a distal end 260 that is attached to the distal end 218 of the outer shaft 244 via a cylindrical pin 262. The pin 262 is received in a bore 264 defined in the outer shaft 244 such that the inner shaft 240 may be rotated about its longitudinal axis 266 relative to the outer shaft 244. The proximal end (not shown) of the inner shaft 240 is connected to the drive mechanism 224. As such, when the drive mechanism 224 is energized, the inner shaft 240 is rotated about its axis 266.
The other inner shaft 242 also has a distal end 270 that is attached to the distal end 218 of the outer shaft 244 via a cylindrical pin 272. The pin 272 is received in a bore 274 defined in the outer shaft 244 such that the inner shaft 242 may be rotated about its longitudinal axis 276 relative to the outer shaft 244. The proximal end (not shown) of the inner shaft 242 is connected to the drive mechanism 224. As such, when the drive mechanism 224 is energized, the inner shaft 242 is rotated about its axis 276.
As shown in FIG. 4, each of the shafts 240, 242 is electrically connected to the RF generator 220. In other embodiments, one of the shafts 240, 242 may be connected to directly ground. The shafts 240, 242 are positioned such that they are electrically-isolated from each other. In the illustrative embodiment, each of the shafts 240, 242 is formed from a conductive metallic material such as, for example, stainless steel. Each of the shafts 240, 242 may be formed as a single monolithic metallic component. In other embodiments, the shafts 240, 242 may be formed from one or more sections that are welded, press fit, or swaged together. The shafts may also be formed from bio-compatible surgical steels such as, for example high carbon steel or nickel alloy. The outer shaft 244 is formed from a non-conductive material such as plastic.
As shown in FIG. 4, the shafts 240, 242 include a plurality of cutting teeth 280, 282, respectively, that are axially aligned with the cutting slot 216. In the illustrative embodiment, some of the teeth 280, 282 protrude from the cutting slot 216. In other embodiments, the teeth 280, 282 may be positioned below the opening 252 in the outer shaft 244. The teeth 280, 282 also include blunt tips 284 in the illustrative embodiment. It should be appreciated that in other embodiments each tip 284 may include a sharpened cutting edge.
As shown in FIGS. 4-5, each tooth 280 of the shaft 240 is interdigitated with a corresponding tooth 282 of the other shaft 242. When the drive mechanism 224 is energized, the shaft 240 is configured to rotate in a direction opposite the direction of rotation of the shaft 242, as indicated by arrows 290, 292. The rotation of the shafts 240, 242 is synchronized such that the teeth 280, 282, like the rest of the shafts 240, 242, remain spaced apart and electrically isolated from one another during rotation.
In other words, the shafts 240, 242 and the RF generator 220 form a circuit 294 that is incomplete or open unless a conductor is added to electrically connect the shafts 240, 242. In the illustrative embodiment, the circuit 294 is configured to be completed or closed by the tissue to be removed from the patient. As shown in FIG. 6, when the shafts 240, 242 are advanced into contact with the target tissue 296 with the RF generator 220 energized, the target tissue 296 is placed in contact with both shafts 240, 242 such that the tissue 296 acts as the conductor to complete or close the circuit 294. With the circuit 294 closed, alternating electrical current flows through the tissue 296 and the shafts 240, 242 at radio frequencies, thereby cauterizing the tissue 296 without causing pain to the patient.
Additionally, the synchronized rotation of the shafts 240, 242 pinches the cauterized tissue 296 and draws the cauterized tissue 296 into the cutting slot 216. The suction provided by the vacuum pump 48 facilitates the passage of the tissue through the shafts 240, 242. As shown in FIG. 6, the tissue is minced or morcellated by the cutting teeth 280, 282 to reduce the size of the tissue particles 298 being drawn down the passageway 250, thereby reducing the possibility of clogging. The drive mechanism 224 is operable to vary the rotation speed of the shafts 240, 242 to change the rate of morcellation.
Referring now to FIGS. 7-9, a distal end 318 of another cutting tool or blade assembly 314 is shown. A pair of cutting slots 316, 320 are defined at the distal end 318 of the assembly 314, as described in greater detail below. Similar to the cutting tool 214, the cutting assembly 314 includes a pair of inner shafts 340, 342 and an outer shaft 344 that is secured to, for example, the hand piece 212. It should be appreciated that the cutting tool 314 may be modular in a manner similar to the cutting tool 14 or configured to be permanently fixed to the hand piece. In the illustrative embodiment, the proximal ends (not shown) of the inner shafts 340, 342 are connected to a drive mechanism of the hand piece such that the inner shafts 340, 342, like the inner shafts 240, 242, may be rotated about their respective longitudinal axes 346, 348.
As shown in FIG. 8, the inner shaft 340 has an elongated tube 350 that extends from a distal end 352. A passageway 354 is defined therein. In the illustrative embodiment, the tube 350 and the passageway 354 have a constant diameter along the length of the shaft 340. In other embodiments, the tube 350 and/or passageway 354 may be stepped or tapered along their lengths to facilitate suction and reduce the possibility of clogging in certain applications. The elongated tube 350 also includes an opening 356 that is axially aligned with the cutting slot 316. The passageway 354 and hence opening 356 are connected to a vacuum pump or other vacuum source.
The inner shaft 340 also includes a cutting edge 358 that defines one side of the opening 356. The cutting edge 358 is illustratively serrated and includes a number of cutting teeth 360. In other embodiments, the inner shaft may include additional cutting edges and the cutting edges may include additional cutting teeth. In still other embodiments, one or both of the edges may include a single, continuous sharp edge.
The other inner shaft 342 has an elongated tube 370 that extends from a distal end 372. A passageway 374 is defined therein. In the illustrative embodiment, the tube 370 and the passageway 374 have a constant diameter along the length of the shaft 342. In other embodiments, the tube 370 and/or passageway 374 may be stepped or tapered along their lengths to facilitate suction and reduce the possibility of clogging in certain applications. The elongated tube 370 also includes an opening 376 that is axially aligned with the cutting slot 320 of the outer shaft 344. The passageway 374 and hence opening 376 are connected to a vacuum pump or other vacuum source.
The inner shaft 342 also includes a cutting edge 378 that defines one side of the opening 376. The cutting edge 378 is illustratively serrated and includes a number of cutting teeth 380. In other embodiments, the inner shaft may include additional cutting edges and the cutting edges may include additional cutting teeth. In still other embodiments, one or both of the edges may include a single, continuous sharp edge.
As shown in FIG. 8, the outer shaft 344 also includes an elongated tube 390 that has a rounded, convex surface 392 at the distal end 318. A pair of passageways 394, 396 are defined therein. In the illustrative embodiment, the tube 390 and the passageways 394, 396 have a constant diameter along the length of the shaft 344. In other embodiments, the tube 390 and/or passageway 394, 396 may be stepped or tapered along their lengths to facilitate suction and reduce the possibility of clogging in certain applications. In the illustrative embodiment, the shaft 340 is positioned in the passageway 394 and the other shaft 342 is positioned in the other passageway 396. In that way, the shafts 340, 342 are isolated from each other. In other embodiments, the shaft 344 may include only a single passageway.
The inner shaft 344 also includes a pair of cutting edges 398, 400 that define the sides of the cutting slots 316, 320, respectively. The cutting edges 398, 400 are illustratively serrated and include a number of cutting teeth 402, 404. In other embodiments, the outer shaft may include additional cutting edges and the cutting edges may include additional cutting teeth. In still other embodiments, one or both of the edges may include a single, continuous sharp edge.
As shown in FIG. 8, each of the shafts 340, 342 is electrically connected to the RF generator 220. In other embodiments, one of the shafts 340, 342 may be connected to directly ground. As described above, the shafts 340, 342 are positioned such that they are electrically-isolated from each other. In the illustrative embodiment, each of the shafts 340, 342 is formed from a conductive metallic material such as, for example, stainless steel. Each of the shafts 340, 342 may be formed as a single monolithic metallic component. In other embodiments, the shafts 340, 342 may be formed from one or more sections that are welded, press fit, or swaged together. The shafts may also be formed from bio-compatible surgical steels such as, for example high carbon steel or nickel alloy. The outer shaft 344 is formed from a non-conductive material such as plastic. It should be appreciated that in other embodiments the outer shaft may be formed from a conductive material.
When the drive mechanism is energized, the shaft 340 is configured to rotate in a direction opposite the direction of rotation of the shaft 342, as indicated by arrows 406, 408 in FIGS. 7 and 8. The rotation of the shafts 340, 342 is synchronized. Like the circuit 294, the shafts 340, 342 and the RF generator 220 form a circuit 410 that is incomplete or open unless a conductor is added to electrically connect the shafts 340, 342. In the illustrative embodiment, the circuit 410 is configured to be completed or closed by the tissue to be removed from the patient.
In use, the surgeon may toggle or press a control on a hand piece to energize the drive mechanism and cause the shafts 340, 342 to rotate. The surgeon may also separately activate the vacuum pump 48 and the RF generator 220. It should be appreciated that the drive mechanism may operate a single, continuous speed or at a variable speed.
To remove tissue, the distal end 318 of the blade assembly 314 is advanced into contact with the target tissue 412 as shown in FIG. 9. As the inner shafts 340, 342 are rotated about their respective axes 346, 348, the cutting edges 358, 378, 398, and 400 may be advanced into contact with the target tissue 412. When the shafts 340, 342 are advanced into contact with the target tissue 412 with the RF generator 220 energized, the target tissue 412 is placed in contact with both shafts 340, 342 such that the tissue 412 acts as the conductor to complete or close the circuit 294. With the circuit 410 closed, alternating electrical current flows through the tissue 412 and the shafts 340, 342 at radio frequencies, thereby cauterizing the tissue 412 without causing pain to the patient.
The movement of the inner shaft 340 in the direction indicated by arrow 406 presses the tissue 412 into engagement with the cutting edges 358, 398, and the edges 358, 398 cooperate to slice the target tissue 412. Similarly, movement of the inner shaft 342 in the direction indicated by arrow 408 presses the tissue 412 into engagement with the cutting edges 378, 400, which cooperate to slice the target tissue 412. As shown in FIG. 10, the severed portions 414 of the tissue are drawn into the passageways 354, 374. When the vacuum pump is activated, a suction air flow is created to draw the severed portions 414 and other debris out of the passageways 354, 374 and the surgical instrument.
In other embodiments, the outer shaft 344 may be formed from a conductive material like the inner shafts 340, 342. In such embodiments, the shaft 344 may also be electrically coupled to the RF generator or to ground. Both shafts 340, 342 may carry a charge of one polarity and the shaft 344 may carry the other charge. In such embodiments, insulating elements may be included to isolate the shafts 340, 342, 344 from each other.
Referring now to FIGS. 11 and 12, another surgical instrument (hereinafter surgical instrument 510) is disclosed. Some of the features of the embodiment of FIGS. 11-12 are similar to the embodiment described above. For such features, the references numbers from the embodiment described above will be used to identify those features in FIGS. 11-12. As shown in FIG. 11, the instrument 510 includes a tool body 512 and a cutting tool assembly 14 that extends outwardly from the tool body 512 to a distal end 18. A cutting slot 16 is positioned at the closed distal end 18 of the cutting tool assembly 14. As described above in regard to FIGS. 1-2, the cutting tool assembly 14 is modular and configured to be attached and detached from the tool body 512, as shown in FIG. 12.
In the illustrative embodiment, the instrument 510 includes a handle 514 that is attached to tool body 512. The handle 514 includes a power supply 516 such as, for example, a rechargeable electric battery. As shown in FIG. 12, the handle 514 is also modular and may be attached and detached from the body 512. A pair of terminals 518, which extend outwardly from the handle 514, are configured to engage a corresponding pair of terminals (not shown) in the tool body 512 such that power may be supplied from the power supply 516 to a drive mechanism 66 positioned in the tool body 512.
In use, the handle 514 is attached to the tool body 512 as shown in FIG. 11. A user may depress button 520 on the handle to operate the drive mechanism 66 as described above to operate the cutting tool assembly 14. The modular configuration of the handle permits the user to select a handle including a fully-charged power supply 516. The user may also detach a handle 514 including a spent power supply 516 and use an external charging station to recharge the battery.
The tool body 512, handle 514, and cutting tool assembly 14 may be formed from materials suitable for autoclaving. In other embodiments, each component may be configured for only a single use.
Referring now to FIGS. 13-22, other embodiments of surgical instruments (hereinafter surgical instruments 610, 710, 810, 910) are disclosed. Some of the features of the embodiments of FIGS. 13-22 are similar to the embodiments described above. For such features, the references numbers from the embodiments described above will be used to identify those features in FIGS. 13-22. As shown in FIG. 13, a distal wire tip 612 is attached to another cutting tool or blade assembly 614. The blade assembly 614, similar to the blade assembly 14, includes an inner blade shaft 90, which is positioned within an outer blade shaft 92. The inner blade shaft 90 is configured to be rotated about its longitudinal axis 100 by an electric motor or other mechanism. As described above, the drive mechanism may be positioned in a hand piece (not shown) that is similar to the hand piece 12 described above. In other embodiments, the drive mechanism may take the form of a cable drive mechanism similar to that described in U.S. Patent App. Ser. No. 61/992,596, entitled “APPARATUS AND METHOD FOR TREATING DISORDERS OF THE EAR, NOSE, AND THROAT,” which is expressly incorporated by reference.
As shown in FIG. 13, a cutting slot 16 is defined in the outer blade shaft 92, and the inner blade shaft 90 includes a longitudinal passageway 94 that opens into the cutting slot 16. The longitudinal passageway 94 is connected to a vacuum pump 48 through a connector (not shown) similar to the connector 42 described above in regard to FIGS. 1 and 2. The inner blade shaft 90 and the outer blade shaft 92 also include cutting edges 96, 98, respectively, that are axially aligned with the cutting slot 16. The edges 96, 98 are configured to cut or shaft tissue placed in the cutting slot 16 when the inner blade shaft 90 is rotated about its longitudinal axis 100.
The surgical instrument 610 also includes a cauterizing mechanism 616 to enable cautery while dissecting and resecting tissue. In the illustrative embodiment, the cauterizing mechanism 616 includes the distal wire tip 612, which is powered electrically by a power source 618 that is configured to provide a low voltage direct current (DC). In that way, electrical current is prevented from being transmitted to the patient. In other embodiments, the power source may be a high frequency AC current generator.
As shown in FIG. 13, the cauterizing mechanism 616 includes a pair of wires 620, 622 that extend the length of the blade assembly 614. Each of the wires 620, 622 is configured to provide power from the power source 618 to the distal wire tip 612. Each of the wires 620, 622 is electrically insulated and isolated such that electrical power and heat are not transmitted to the patient. On the other hand, the distal wire tip 612 is exposed and may be placed in contact with a patient's tissue to cauterize the tissue.
In the illustrative embodiments, the wires 620, 622 and the wire tip 612 are formed from a single piece of wire having a cross sectional diameter of between about 0.010 inches and about 0.020 inches that is attached to the blade assembly 614. The blade assembly 614 has a cross sectional diameter at its distal end of between about 2 millimeters and about 4 millimeters. The wire is sized to ensure the distal wire tip 612 is heated to a temperature hot enough to cauterize tissue by high resistance electrical current. For example, the heated temperature of the wire may be above 50 degrees Celsius. The wire is illustratively made from a high resistance, high strength metal that can heat up instantaneously to cauterize the tissue and also cool down quickly when power is removed. It should be appreciated that in other embodiments the wire diameter may be changed depending on the diameter of the distal end of the blade assembly 614.
In the illustrative embodiment, the power source 618 is separate from the power source (not shown) that energizes the drive mechanism of the surgical instrument 610. In that way, the distal wire tip 612 may be supplied with power and operated independently of the blade assembly 614. In other embodiments, a single, common power source may be used.
In use, the distal wire tip 612 and the blade assembly 614 may be advanced unpowered with an endoscope into the nasal passage of a patient to provide a view of the surgical area. The surgeon may toggle or press a control button (not shown) to supply power to the distal wire tip 612. As electrical current flows through the tip 612, the tip 612 is rapidly heated. The surgeon may then advance the distal wire tip 612 into contact with a patient's tissue, thereby cauterizing the tissue or a tissue plane. With the distal wire tip 612 powered or unpowered, the surgeon may then advance the distal end of the blade assembly 614 into contact with the cauterized tissue. While doing so, the surgeon may activate the drive mechanism to cause the inner shaft 90 to rotate relative to the outer shaft 92. The surgeon may also separately activate the vacuum pump 48. To remove tissue, the target area is positioned in the cutting slot 16. As the inner blade shaft 90 is rotated about its axis 100, the cutting edge 96, for example, is advanced into engagement with the tissue. The rotation of the blade shaft 90 moves the tissue into contact with the cutting edge 98 of the blade shaft 92. The cutting edges 96, 98 cooperate to slice and resect the tissue, which is advanced into the passageway 94 and evacuated by the vacuum pump 48.
Referring now to FIG. 14, another cutting tool or blade assembly 714 of a surgical instrument 710 is shown. In the illustrative embodiment, the surgical instrument 710 includes a light source 712 that is attached to the blade assembly 714 to provide additional visualization of the distal end 18 of the blade assembly 714 during a procedure. The light source 712 is illustratively a white light emitting diode (LED) that is less than 1.0 millimeter in diameter and is powered by an external power source (not shown). In other embodiments, the light source 712 may be fiber optic light. In still other embodiments, various color sources may be used as well. It should also be appreciated that more than one light source may be used at one or more positions along the blade assembly 714 to indicate depth or length along the blade assembly 714.
While the blade assembly 714 is similar to the blade assembly 14 described above, it should be appreciated that the light source 712 may be used with any of the blade assemblies described above. A similar light source may also be used with any of the shaft configurations shown and described in U.S. Patent App. Ser. No. 61/992,596, entitled “APPARATUS AND METHOD FOR TREATING DISORDERS OF THE EAR, NOSE, AND THROAT.”
In use, the light source 712 and the distal end 18 of the blade assembly 714 may be advanced into the nasal passage of a patient to provide a view of the surgical area. The light source 712 projects light to illuminate the submucosal pocket during resection. The resection may be performed with the naked eye or with an endoscope. In addition to illuminating the submucosal pocket, the light source 712 creates a glow on the external tissue surface, thereby indicating to the surgeon the location of the light surface 712 and hence the distal end 18 of the blade assembly 714.
Referring now to FIG. 15, another surgical instrument 810 is shown. Similar to the surgical instrument 10 described above, the surgical instrument 810 includes a hand piece 12 and a blade assembly 14 configured to be coupled to the hand piece 12. The blade assembly 14 includes a cutting slot 16 that is positioned at its distal end 18.
The hand piece 12 includes a body 22 and a connector 36 attached to the longitudinal end 40 of the body 22. The connector 36 is configured to be coupled with corresponding connector 42 of a vacuum pump (not shown). The hand piece 12 also includes a connector 812 that is attached to the longitudinal end 40 of the body 22. The connector 812 is configured to mate with a corresponding connector 814 of an electrical cable 816 such that power may be supplied to the electrically-operated components (e.g., motor 66) of the hand piece 12, as described in greater detail below.
The hand piece 12 also includes a control panel 60 positioned on the elongated body 22. In the illustrative embodiment, the control panel 60 includes a single control button 62, which may be toggled to operate the surgical instrument 810. In other embodiments, the hand piece 12 may include additional controls such as toggles, levers, or other buttons to individually activate the electrically-operated components of the instrument 810 and/or the vacuum pump.
As shown in FIG. 15, the electrical cable 816 is connected to a control box 820. The control box 820 has a control panel 822 that includes a control button 824 and a number of indicators 826. Another electrical cable 828 extends from the control box 820 and includes a connector (not shown) configured to be coupled to a standard domestic power outlet (not shown). In other embodiments, the surgical instrument 810 may be battery-powered. In such embodiments, the control box 820 may also include one or more batteries. The control box 820 also houses circuitry 830, such as, for example, switches, regulators, and so forth, configured to regulate power supplied from the domestic power outlet to the electrically-operated components of the hand piece 12.
In the illustrative embodiment, the control box 820, cable 816, and cable 828 are sized such that the control box 820 may be positioned on the floor adjacent to the surgeon's work area. In the illustrative embodiment, the control box 820 fits within a prism of approximately six inches by four inches by inches.
The control button 824 on the control box 820 is sized such that it may be operated by the foot of the surgeon. In other embodiments, the control box 820 may include additional controls such as toggles, levers, or other buttons to individually activate the electrically-operated components of the instrument 810 and/or the vacuum pump. In the illustrative embodiment, when either of the control buttons 62, 824 is pressed, a switch or switches (not shown) of the circuitry 830 closes to connect the power source to the motor 66, thereby energizing the motor 66 and operating the blade assembly 14. In that way, the surgeon may use either of the control buttons 62, 824 to activate the surgical instrument 810.
As described above, the control box 820 also includes the indicators 826. In the illustrative embodiment, the indicators 826 are a pair of colored LEDs 832, 834 connected to, and powered by, the circuitry 830. The circuitry 830 is operable to energize one or both of the LEDs 832, 834 to provide a visual indication to the user of the condition of the unit. For example, the LED 832 may be energized continuously to indicate power is supplied to the surgical instrument 810 and/or control box 820, while LED 834 may be energized intermittently to indicate only when the motor 66 is energized. It should be appreciated that in other embodiments other indicators such as, for example, displays and audible indicators may be used to inform the user of the condition of the surgical instrument 810.
In other embodiments, the surgical instrument 810 may be cable-driven. In such embodiments, the control box may be configured as a mechanical drive box, and the cable connecting the control box to the hand piece may include coaxial drive cable. The drive cable may include a core that serves as the rotational power source for the hand piece.
Referring now to FIGS. 16-22, a surgical instrument 910 is shown. As shown in FIG. 16, the instrument 910 includes a hand piece 912 and a blade assembly 914 that extends outwardly from the hand piece 912 to a distal end 918. In the illustrative embodiment, the blade assembly 914 is secured to the hand piece 912 and not configured to be detached. Additionally, the instrument 910 is configured to be disposed after a single use.
A cutting slot 16 is positioned at the distal end 918 of the blade assembly 914. This embodiment of the surgical instrument is configured to be used with a cable drive mechanism 920, which may be included in a portable surgical console or a control box similar to the one described above. The cable drive mechanism 920 is used to operate the blade assembly 914 to shave or cut tissue within the cutting slot 16. The surgical instrument 910 is also configured to be coupled to a negative pressure source such as a vacuum pump (not shown) to evacuate the severed tissue from the instrument 610.
The hand piece 912 of the surgical instrument 910 includes an elongated body 922. A handle 924 extends downwardly from the body 922 and includes a grip 926 that is configured to be grasped by a user during operation of the surgical instrument 910. As shown in FIGS. 16 and 18, the handle 924 is positioned on the elongated body 922 such that the center of gravity of the device is centered in the crook of the hand. In that way, the surgical instrument 910 is balanced in the hand, and the blade assembly 914 can be maintained horizontally neutral without undue effort.
The hand piece 912 may be formed from a plastic, rigid polymer, or other rigid materials. In the illustrative embodiment, the surgical instrument 910 is sized to be approximately 120 grams in weight. The positioning of the handle 924 at the center gravity and the light weight of the surgical instrument 910 each provide ergonomic benefit to the user.
As shown in FIG. 16, the blade assembly 914 extends outwardly from a longitudinal end 932 of the body 922. The hand piece 912 also includes a connector 36, which is positioned at the opposite longitudinal end 940 of the body 922. The connector 36 is configured to engage a hose connector 42 of the vacuum pump (not shown) such that the hand piece 912 (and hence the blade assembly 914) may be connected to the vacuum pump.
The hand piece 912 also includes a connector 938 that extends downwardly from the handle 924. The connector 938 is configured to engage a connector 942 of a drive cable 944 of the drive mechanism 920. One such mechanism is commercially available from Heraeus Medical Components. The connectors 938, 942 also includes a pair of electrical contacts (now shown), which permit the user to activate the cable drive mechanism 920 using the hand piece 912.
As shown in FIGS. 16, the hand piece 912 also includes a control panel 960 positioned on the handle 924. In the illustrative embodiment, the control panel 960 includes a single control button 962, which may be toggled to activate the cable drive mechanism 920. In this embodiment, the vacuum pump may be activated using a foot pedal or switch located on the pump. In other embodiments, the hand piece 912 may include additional controls such as toggles, levers, or other buttons. It should also be appreciated that in other embodiments the cable drive mechanism 920 and the pump 48 may be activated using a foot pedal or other control device.
As shown in FIG. 16, the hand piece 912 includes an electrical circuitry 964 that is positioned in the elongated body 622. When the button 962 is toggled or pressed by the user, the circuitry 964 is configured to generate an electrical output to activate the cable drive mechanism 920. The hand piece 912 also includes a transmission assembly 966 engaged with the connector 942 of the cable drive mechanism 920 within the connector 938. It should be appreciated that the transmission assembly 966 may include any gears, shafts, or other devices necessary to transmit power. When the cable drive mechanism 920 is activated, the cable core 968 (see FIGS. 19 and 21) is rotated, thereby transmitting rotational power to the blade assembly 914 via the transmission assembly 966.
Similar to the blade assembly 14 described above, the blade assembly 914 includes an inner blade shaft (not shown) that is configured to rotate relative to an outer blade shaft 92 to slice tissue advanced into the cutting slot 16. Another exemplary blade assembly and transmission mechanism for a cable-driven surgical instrument is shown and described in U.S. Patent App. Ser. No. 61/992,596, entitled “APPARATUS AND METHOD FOR TREATING DISORDERS OF THE EAR, NOSE, AND THROAT.”
As shown in FIG. 16, the drive mechanism 920 includes a housing 970 that encloses a drive unit 972. The housing 970 includes a connector 974 that extends outwardly from the housing 970. The connector 974 is configured to engage a corresponding connector 976 of the cable 944 such that the rotational power from the drive unit 972 may be transmitted to the cable core 968. The drive mechanism 920 also includes a power cable 978 configured to be connected to a domestic power outlet to supply electrical power to the drive unit 972. The drive unit 972 is operable to rotate the inner blade shaft at speeds between about 500 and about 5,000 rpm, with an oscillatory frequency of between 2 Hz and 5 Hz.
As described above, the surgical instrument 910 includes a drive cable 944 that has a connector 942 secured to the handle 924 of the hand piece 922 and another connector 976 attached to the housing 970. As shown in FIG. 16, the cable 944 includes an outer sheath 980 that extends between a longitudinal end 982 and an opposite longitudinal end 984. The connector 976 is secured to the longitudinal end 984; in the illustrative embodiment, a spheroidal joint 986 is attached to the opposite longitudinal end 982, as described in greater detail below.
As shown in FIG. 19, the sheath 980 includes an outer surface 988 that is tapered such that the sheath 980 has a larger diameter at the end 984 than at the end 982. In the illustrative embodiment, the sheath 980 is formed form an inner layer of Teflon, a middle layer of steel wound around the Teflon, and an elastomeric outer layer. The layers cooperate to allow the sheath 980 to bend and flex as shown in FIG. 16. It should be appreciated that in other embodiments the sheath may be formed as a composite of other materials.
As shown in FIG. 21, the sheath 980 has an inner passageway 990 defined therein. The passageway 990 extends between the ends 982, 984, and the cable core 968 of the cable 944 is positioned therein. In the illustrative embodiment, the cable core 968 includes a brass inner core and a spring steel wound outer casing such that the cable core 968 is permitted to bend and flex. It should be appreciated that in other embodiments the core 968 may be formed as a composite of other materials.
In nasal polyp surgeries, vibration and whip are issues for precision control of the device. To reduce the vibration and whip transmitted to the handle 924, the core 968 is frictionally isolated from sheath 980 by a plurality of support bearings 1000, 1002, which are positioned at the opposite ends 982, 984. In the illustrative embodiment, two roller bearings 1000 are positioned at the end 982 and another two roller bearings 1002 are positioned at the end 984. Additionally, in the illustrative embodiment, the bearings 1000, 1002 and the cable core 968 are lubricated to further reduce vibration.
In the illustrative embodiment, whip is further reduced by the tapering of the cable 944 such that the sheath 980 has a smaller diameter at the handle 924 (i.e., the end 982). This reduction in diameter also assists with the flexibility and maneuverability of the handle 924 and hence the blade assembly 914. The diameter of the sheath 980 at the opposite end 984 is larger and more robust to withstand the inertial torque load of the drive unit 972.
As described above, the cable 944 also includes a spheroidal joint 986 that is attached to the opposite longitudinal end 982 of the sheath 980. As shown in FIG. 17, the spheroidal joint 986 has a lower end 1010 coupled to the end 982 of the sheath 980 and another end 1012 that includes the connector 942. The cable core 968 extends outwardly from the end 982 of the sheath 980, through a passageway (not shown) defined in the joint 986, and into the connector 938. In the illustrative embodiment, the joint 986 includes a ball-shaped head 1014 that is received in a cup-shaped housing 1016. During operation, the joint 986 permits the handle 924 to move relative to the sheath 980 in the directions indicated by arrows 1018, 1020 during operation. In that way, the joint 986 further isolates the handle 924 from the vibration and whip the cable 944.
Referring now to FIGS. 20 and 22, another embodiment of a drive cable (hereinafter cable 1044) for use with the surgical instrument 910 is shown. Although not shown in FIG. 20, the cable 1044, like the cable 944, includes the connectors 942, 976 and the spheroidal joint 986. The cable 1044, like the cable 944, is also configured to reduce vibration and whip by reducing the diameter of its handle end 1082. In contrast with the cable 944, the cable 1044 has a stepped outer sheath 980 to reduce the diameter of the handle end 1082 of the sheath 980 relative to the motor end 1084 of the sheath 980, as shown in FIGS. 20 and 22.
To reduce the vibration and whip transmitted to the handle 924, the core 1068 of the cable 1044 is frictionally isolated from sheath 1080 by a plurality of support bearings 2000, 2002, 2004, which are positioned at the opposite ends 1082, 1084 and at the stepped section 1086 of the sheath 1080. In the illustrative embodiment, two roller bearings 2000 are positioned at the end 1082, another two roller bearings 2002 are positioned at the end 1084, and two more roller bearings 2004 are positioned at the stepped section 1086. Additionally, in the illustrative embodiment, the bearings 2000, 2002, 2004 and the cable core 1068 are lubricated to further reduce vibration.
It should be appreciated that the size and configuration of each of the instruments, blade assemblies, and other cutting tools described herein permit the devices to be portable and facilitate the ease of use of the device in surgical procedures. It should be appreciated that in other embodiments the RF generator may be omitted and the instruments configured to remove tissue through the mincing, pinching, or cutting actions described above.
While the disclosure has been illustrated and described in detail in the drawings and foregoing description, such an illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only illustrative embodiments have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected. For example, it should be understood that the materials used to form the various surgical instruments described herein may be modified or changed to reduce the weight of the instrument and facilitate single-handed use. Similarly, other materials may be selected to reduce friction of the inner passageways and outer surfaces. Still other materials may be selected for their anti-reflective properties. Additionally, as described above, the materials used to form the distal ends of the inner and outer blade shafts are dissimilar metallic materials. It should be appreciated that in other embodiments other dissimilar materials may be used. In still other embodiments, the same materials may be used. It should also be appreciated that in other embodiments any of the inner shafts and outer shafts described may utilize the shaft configurations shown and described in U.S. Patent App. Ser. No. 61/992,596, entitled “APPARATUS AND METHOD FOR TREATING DISORDERS OF THE EAR, NOSE, AND THROAT,” which is expressly incorporated by reference.
There are a plurality of advantages of the present disclosure arising from the various features of the apparatus, system, and method described herein. It will be noted that alternative embodiments of the apparatus, system, and method of the present disclosure may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of the apparatus, system, and method that incorporate one or more of the features of the present invention and fall within the spirit and scope of the present disclosure.

Claims

1. A surgical instrument comprising:

an electrical power source configured to generate an alternating current,

a hand piece configured to be coupled to the electrical power source,

an outer shaft extending distally from the hand piece, the outer shaft having a slot defined in a distal end,

a first inner shaft positioned in the outer shaft, the first inner shaft being configured to rotate relative to the slot in a first direction, and

a second inner shaft positioned in the outer shaft, the second inner shaft being configured to rotate relative to the slot in a second direction opposite the first direction,

wherein (i) the first inner shaft is electrically connected to the electrical power source, (ii) the second inner shaft is electrically conductive, and (iii) the first inner shaft is electrically isolated from the second inner shaft.

2. The surgical instrument of claim 1, wherein:

the first inner shaft includes a first plurality of splines that are aligned axially with the slot, and

the second inner shaft includes a second plurality of splines that are interdigitated with the first plurality of splines of the first inner shaft.

3. The surgical instrument of claim 2, wherein the outer shaft has a passageway defined therein, the passageway being configured to be fluidly coupled to a negative pressure source.

4. The surgical instrument of claim 1, wherein the distal end of the outer shaft is formed from a non-conductive material.

5. The surgical instrument of claim 1, wherein the outer shaft includes a first plurality of cutting teeth that partially define the slot at the distal end.

6. The surgical instrument of claim 5, wherein the first inner shaft includes a second plurality of cutting teeth aligned axially with the first plurality of cutting teeth.

7. The surgical instrument of claim 6, wherein the first inner shaft includes a passageway, and the first plurality of cutting teeth and the second plurality of cutting teeth are configured to cooperate to cut tissue advanced into the passageway through the slot.

8. The surgical instrument of claim 7, wherein:

the outer shaft includes a third plurality of cutting teeth that partially define a second slot in the distal end, and

the second inner shaft includes a fourth plurality of cutting teeth that are aligned axially with the third plurality of cutting teeth.

9. The surgical instrument of claim 8, wherein the second inner shaft includes a second passageway, and the third plurality of cutting teeth and the fourth plurality of cutting teeth are configured to cooperate to cut tissue advanced into the second passageway through the slot.

10. The surgical instrument of claim 1, wherein the hand piece includes a negative pressure source connector configured to be coupled to a negative pressure source to fluidly connect the outer shaft to the negative pressure source.

11. The surgical instrument of claim 1, further comprising a drive mechanism configured to rotate the first inner shaft and the second inner shaft relative to the outer shaft.

12. The surgical instrument of claim 11, wherein the drive mechanism includes an electric motor positioned in the hand piece.

13. The surgical instrument of claim 1, wherein the electrical power source is configured to generate a radio frequency electric current.

14. The surgical instrument of claim 1, wherein the outer shaft has a rounded, convex distal surface.

15. The surgical instrument of claim 1, wherein the second inner shaft is electrically connected to the electrical power source.

16. The surgical instrument of claim 15, wherein the distal end of the outer shaft is formed from an electrically-conductive material.

17. A method of performing a surgical procedure, the method comprising:

advancing a distal end of a surgical instrument into a cavity of a patient,

activating the surgical instrument to (i) rotate a first inner shaft in a first direction within an outer shaft, and (ii) rotate a second inner shaft in a second direction opposite the first direction within the outer shaft, and

advancing the first inner shaft and the second inner shaft into contact with a portion of a patient's tissue in the cavity such that the patient's tissue contacting the first inner shaft and the second inner shaft completes an electrical circuit and electrical current flows through the portion of the patient's tissue.

18. The method of claim 17, wherein activating the surgical instrument includes generating negative pressure to draw the portion of the patient's tissue into a passageway defined in the surgical instrument.

19. The method of claim 17, wherein advancing the first inner shaft and the second inner shaft into contact with the portion of the patient's tissue includes pinching the portion of the patient's tissue between a plurality of splines.

20. The method of claim 17, wherein advancing the first inner shaft and the second inner shaft into contact with the portion of the patient's tissue includes (i) engaging a first plurality of cutting teeth of the first inner shaft with the portion of the patient's tissue, and (ii) engaging a second plurality of cutting teeth of the second inner shaft with the portion of the patient's tissue.

21. The method of claim 20, wherein advancing the first inner shaft and the second inner shaft into contact with the portion of the patient's tissue further includes engaging a set of cutting teeth of the outer shaft with the portion of the patient's tissue.

22. The method of claim 17, wherein the electrical circuit includes the outer shaft.

23. The method of claim 17, wherein the first inner shaft is isolated electrically from the second inner shaft until advanced into contact with the patient's tissue.

24. A surgical instrument comprising:

a hand piece,

an outer shaft coupled to the hand piece that extends to a distal end, the outer shaft having a first plurality of cutting teeth defined at the distal end,

a hub including a barb that extends outwardly from a depressible outer wall that is movable between (i) a first position in which the barb is engaged with the hand piece to secure the outer shaft to the hand piece and (ii) a second position in which the barb is disengaged from the hand piece to permit the outer shaft to be detached from the hand piece,

an inner shaft positioned in the outer shaft, the inner shaft having a passageway and a second plurality of cutting teeth, and

wherein the surgical instrument includes a cutting slot that is partially defined by the first plurality of cutting teeth, and the inner shaft is configured to rotate relative to the outer shaft such that the first plurality of cutting teeth and the second plurality of cutting teeth cooperate to cut tissue advanced into the passageway through the cutting slot.

25. A surgical instrument as shown and described above.