WO2005023084A2

WO2005023084A2 - Surgical instrument and methods of using for otolaryngology surgeries

Info

Publication number: WO2005023084A2
Application number: PCT/US2004/020093
Authority: WO
Inventors: Jeremy S. Melker
Original assignee: University of Florida
Current assignee: University of Florida
Priority date: 2003-09-03
Filing date: 2004-06-22
Publication date: 2005-03-17
Anticipated expiration: 2006-03-03
Also published as: WO2005023084A3

Abstract

Disclosed herein are methods and devices for performing otolaryngology surgeries utilizing a powered surgical instrument (10) that comprises a cutting feature, a suction feature, and a cautery feature. The disclosed embodiments address undue hemorrhaging that occurs during many ENT surgical procedures. In exemplified embodiments, methods for performing tonsillectomy and/or adenoidectomy are disclosed herein that reduce surgical time and blood loss of the patient.

Description

TITLE OF THE INVENTION SURGICAL INSTRUMENT AND METHODS OF USING FOR OTOLARYNGOLOGY SURGERIES

FIELD OF THE INVENTION

[001] The subject invention relates to the field of medicine broadly, and specifically to the field of surgical instrument and surgical methods for performing various Otolaryngology surgeries.

BACKGROUND

[002] Powered surgical instrumentation has been used for years to perform orthopedic surgeries. Since the early 1980s, this same technology has been adapted for otolaryngology (ENT) surgeries. These techniques and instruments have taken into account the tight confined spaces surgeons must face in many ENT surgeries. [003] For example, Medtronic has developed the XPS Straight Shot handpiece and blade assemblies designed for performing many different ENT surgeries. This powered instrument comprises a motorized handpiece onto which numerous different blade configurations can be attached. The XPS StraightShot handpiece has a front drive shaft rotatably driven by a motor of the handpiece. The front drive shaft has drive pins thereon for drivingly engaging prongs disposed on a proximal end of a blade or cutting member that is to be rotatably driven by the handpiece. The blade or cutting member is selectively engageable and disengeable with the front drive shaft allowing the handpiece to be used to rotatably drive a variety of blades or cutting members selectively coupled therewith. One blade assembly, RADenoid TM Blade www.xomed.com/SurgicalTechniques/surgtech_endo2.asp is configured specifically for Adenoidectomy surgery. It is a curved shaft that assists the surgeon in positioning the instrument at the intended surgical site. Indeed, powered instmmentation has become an invaluable tool for the ENT surgeon. [004] Various other powered surgical handpieces having motors for driving removable blades or cutting members have also been proposed, as illustrated by the Stryker Hummer system of Stryker Endoscopy, San Diego, Calif., the Apex System of Linvatec, Incorporated, Largo, Fla., the PS 3500 and EP-1 Surgical Drive System of Dyonics, Inc. of Andover, Mass. and the Wizard microdebrider system of Xomed, Inc., Jacksonville, Fla. [005] Several surgeries that ENT surgeons perform generate substantial amounts of blood. The tight spaces ENT surgeons must work in combined with the presence of significant amounts of blood make visualization of the surgical site very difficult. Conventionally, ENT surgeons must repeatedly pull out the powered instrument and insert a suction/electrocautery device to aspirate blood and debris. Removal of the powered surgical instrument when bleeding is occuring, and then the subsequent insertion of the suction/electrocautery probe back to the surgical site, and then reinsertion of the powered surgical instrument is a cumbersome task. During the period of time between when the powered instrument is removed and the suction/electrocautery device is inserted, a significant amount of blood can accumulate at the surgical site and make it difficult to see the surgical site. Tissues such as Adenoids and Tonsils are very vascular and generate copious amounts of blood during the surgery. In addition to being time consuming, the switching of instruments or other pauses while tonsillar or adenoid tissue is bleeding is not desirable, and in some cases can be dangerous.

SUMMARY OF THE INVENTION

[006] The subject invention addresses a significant deficiency in conventional microdebrider products. Though existing microdebriders aspirate blood as the surgery is performed, they do not and cannot address the bleeding that occurs after the powered microdebrider is used and while other instruments are being selected by the surgeon to control bleeding. As a result of the foregoing deficiency, surgeons must continually alternate between microdebridement, aspiration/irrigation, and cauterization to maintain a clear surgical field. The subject invention addresses this deficiency by providing a microdebrider device that is equipped with a cautery feature. [007] According to one aspect, the subject invention pertains to a method of performing an ENT surgery (preferably an adenoidectomy or tonsillectomy) that comprises obtaining a powered microdebrider device that comprises a cutting feature, a suction feature and a cautery feature. The method involves cutting a portion or all of the tissue to be removed, applying suction and cauterizing remaining tissue to reduce or prevent blood flow. [008] In a further aspect, the subject invention pertains to a microdebrider device designed for ENT surgery comprising a cutting feature, suction feature and a cautery feature. For example, the subject instrument can also be used in FESS (functional endoscopic sinus surgery) or powered turbinectomy. [009] Use of a surgical instrument comprising a combination of cutting, suction and electrocautery features dramatically improves the efficiency and speed of ENT surgical procedures. This decreases the associated costs of the surgery. Furthermore, the subject methods and instrumentation diminish the amount of patient blood loss, and possible complications that can occur by such blood loss. These and other advantageous aspects of the subject invention are described in further detail below.

DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 is a side view of a powered surgical instrument that may be used in accord with the teachings herein. [0011] Figure 2 is an enlarged view of the tip of the instrument shown in Figure 1. [0012] Figure 3 is a longitudinal cross-sectional view of the distal end of the instrument shown in Figures 2. [0013] Figure 4 is a flow diagram depicting an embodiment of a surgical procedure according to the teachings herein.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] The subject invention is adapted for use in ENT surgeries. Preferred examples of such surgeries include, but are not limited to, powered tonsillectomy and adenoidectomy. Also, the instrumentation and methods may be used in FESS, functional endoscopic sinus surgery, (such as middle eatus antrostomy, ethmoidectomy, sphenoidotomy, and frontal sinusotomy), including, but not limited to, turbinoplasty, septoplasty, and endoscopic medial maxillectomy. [0015] As shown in FIG. 1, a presently preferred embodiment of instrument 10 is provided for performing the inventive ENT surgeries taught herein. The instrument 10 utilizes an electrical power source that is capable of selectively electrically cauterizing. Instrument 10 comprises a handle 90 and an elongated electrically conductive probe 92 that has a proximal end 94 and a distal end 96. Probe 92 is attached at proximal end 94 thereof to electrocautery base 120, which is attached to said handle 90. [0016] Probe 92 has formed in the interior thereof a longitudinally extending lumen 98 (See FIG. 3) communicating with handle 90. Distal end 96 of probe 92 has formed therethrough aperture 100 that permits lumen 98 to communicate with the exterior of probe 92. [0017] Instrument 10 further comprises an elongated drive shaft 102 (See FIG. 3) longitudinally disposed within lumen 98, extending from proximal end 94 of probe 92 to at least aperture 100. Shaft 102 is rotatable about its longitudinal axis within lumen 98. Instrument 10 further comprises cutting tool 104 (See FIG. 2) positioned on shaft 102 opposite aperture 100, so as to pass in close proximity thereto during each rotation of shaft 102. In this manner, any tissue of the patient urged against the exterior of probe 92 at aperture 100 is severed as cutting tool 104 passes by aperture 100. [0018] As used herein the term "cutting tool" is intended to include any device suitable for severing, shaving, grinding, or altering tissue of a patient. Moreover, other devices may be suitable for performing these procedures with an instrument incorporating the teachings of the present invention. That portion of such other devices is intended to be included in the term cutting tool whether incising, tearing or performing repair of reconstruction relative to a patient, whether or not tissue is involved. [0019] The above identified structures assist in allowing the instrument to perform removal of tissue by use of a cutting tool. The instrument, however, is further capable of also functioning to cauterize as needed when determined by observation. Toward that end, distal end 96 of probe 92 includes a preselected region that effects cauterization on a selected basis when tissue of a patient is urged against such preselected region. [0020] Instrument 10 further comprises an electrocautery feature for selectively electrically cauterizing tissue of a patient contacting a preselected region on the exterior of the distal end of probe 92. By way of example and not limitation an example of one such electrocautery feature is shown in FIG. 1, to comprise an electrically insulative layer 108 disposed on the exterior of probe 92. Insulative layer 108 extends from proximal end 94 of probe 92 to the periphery 110 bounding preselected region 106 on the exterior proximal of distal end 96 of probe 92. [0021] According to a preferred embodiment, the body of the patient is grounded and the distal end 96 of the probe 92 is brought to bear against the desired tissue of the patient. A high frequency electrical current flows from the probe 92 through the tissue at that point. That tissue, including any open blood vessels therein, is heated by the current, coagulation the tissue and sealing the open ends of the blood vessels. The foregoing describes basic monopolar electrocautery. Monopolar electrocautery is to be distinguished from coblation or "cold ablation" techniques which destroy tissue by "molecular dissociation." The primary drawbacks of coblation are the cost of specialized handpieces and generators (whereas monoplar current generators are widely available in any OR) as well as the foul odor to which medical staff are exposed when the device is used. In bipolar cautery, current is carried between two closely opposed contact points rather than to a grounding pad placed at a distant site on the patient. These contact points are typically located at the tips of "jeweler's forceps", bayonette forceps, or similar devices and used where precise cautery is required (i.e. near nerves to avoid conduction of current) to control low volume bleeding. Unfortunately, bipolar cautery is largely ineffective where active bleeding is encountered in contrast to monopolar cautery. A couple of considerations for monopolar electrocautery are the risk of conduction injury to nerves if used too close to such structures and the potential for interference with pacemakers or other implanted electrical devices. [0022] Preselected region 106 maybe of any shape or size desired so long as preselected region 106 is formed to permit effective cauterization. Thus, by way of example and not limitation, preselected region 106 could project from probe 92, could be flush with insulative layer 108, or could comprise the entire tip or a portion of the tip of distal end 96. The size and positioning of the preselected region 106 is such as to facilitate desired cauterization without awkward twisting or manipulation of the instrument 10. [0023] According to a preferred embodiment, the electrocautery feature used in the subject instrument utilizes monopolar electrocautery. Briefly, probe 92 is energized by a power source (not shown) and a "ground" patch (not shown) is positioned at a selected spot on the patient. When the probe 92 is energized, the probe 92 completes the electrical circuit as it approaches or contacts tissue of the patient. The energy from the current cauterizes the tissue. A power source is electrically connected to the electrocautery base 120 by cord 112. Activation button 15 is provided for activating the electrocautery feature. [0024] Because of the electrical charge from power source passing through instrument 10, the instrument 10 is capable of providing hemostasis in the patient, and is also capable of cutting tissue of a patient if needed. As an added feature, the present invention thus possesses dual cutting capabilities. Cutting of tissue can occur mechanically by use of a cutting tool. Also, cutting of tissue can occur electro-surgically by use of versatility means. The electro-surgical cutting ability of the present invention is capable of being used in lieu of the cutting tool or complimentary with the cutting tool. Therefore, where tissue of a patient is difficult to sever by use of the cutting tool, the electrocautery feature may be employed to perform medical repair or reconstruction. [0025] Instrument 10 also comprises a suction feature. Tissue debris is sucked through the probe 92 after being excised, and transported out of the instrument through suction tube 11. Debris sucked out of the instrument 10 is transported to an appropriate waste container (not shown). [0026] The probe 92 has defined thereon an irrigation port 114 for supplying fluids to the surgical site. Fluids are delivered to the probe via tube 122. [0027] FIG. 2 is an enlarged detailed view of distal end 96 of probe 92. The enlarged view of distal end 96 depicts cutting tool 104 as serrated blade 124. As can be seen from FIG. 2, periphery 110 bounding preselected region 106 may be formed in a bevel shape to avoid any unnecessary tearing of tissue of the patient when probe 92 is inserted through small spaces such as sinuses, or utilized during the procedure. [0028] As depicted in FIG. 2, probe 92 may have a substantially circular cross section. In this instance, periphery 110 comprises a circle perpendicular to the longitudinal axis of probe 92. Also as seen in FIG. 2, preselected region 106 may comprise tip 126 of distal end 96. [0029] FIG. 3 is a longitudinal cross-sectional view of the distal end of instrument 10 in FIG. 2 and depicts the position of shaft 102 with respect to lumen 98 of probe 92. As is also demonstrated in FIG. 3, shaft 102 extends to at least aperture 100. As shaft 102 rotates about its longitudinal axis within lumen 98, any tissue severed by cutting blade 104 may be drawn down the interior of shaft 102 by use of suitable suction instrument. Any tissue passing through shaft 102 can then be deposited in a suitable container by use of tubing 11 (see Figure 1) and suction equipment (not shown). [0030] FIG. 4 is a flow diagram of a novel surgical procedure utilizing an instrument comprising a cutting feature, a suction feature and an electrocautery feature. According to the procedure, the surgeon first evaluates a possible surgical site and identifies tissue in need of removal 401. Preferably the tissue is a portion or all of a patient's tonsils and/or adenoids. Secondly, the surgeon excises the desired tissue using a powered surgical instrument as described herein 402. Thirdly, using the same powered surgical instrument, and without the need to switch out instruments, the surgeon sucks out (aspirates) the excised tissue 403. Following tissue excision and removal, any of steps 401-404 are repeated as needed 405 to fully remove the tissue as determined by the surgeon. Those skilled in the art will understand that the cutting and aspiration of tissue steps happen very quickly. Thus, the cutting and suctioning steps may happen concurrently or otherwise very closely in time with each other. [0031] Many different microdebridement systems are available on the market. The inventor believes that the microdebridement systems by Xomed, as listed on Xomed's website, www.Xomed.com. are representative of preferred systems to be modified and used according to the teachings herein. Those skilled in the art will appreciate that other known systems could be modified to be used in accordance with the surgical methods taught herein. U.S. Patent Nos. 5,364,395; 6,368,324; and 6,214,001 teach examples of powered instruments that could adapted or modified according to the teachings herein to achieve the novel surgical procedures and instrument taught herein. The teachings of the references cited throughout the specification are incorporated herein by this reference to the extent they are not inconsistent with the teachings herein. It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and the scope of the appended claims.

Claims

What is claimed is:

1. A method of performing an ENT surgery comprising obtaining a powered surgical instrument comprising a cutting feature, a suction feature and a cautery feature; identifying tissue to be removed at a surgical site; cutting said tissue with said powered surgical instrument; suctioning said tissue with said powered surgical instrument; and cauterizing tissue remaining at said surgical site after said cutting step.

2. The method of claim 1 wherein said ENT surgery is tonsillectomy.

3. The method of claim 1 wherein said ENT surgery is adenoidectomy.

4. The method of claim 1 wherein a precauterization step occurs prior to said cutting step.

5. The method of claim 1, wherein said cauterizing step comprises monopolar electrocautery.

6. The method of claim 1 wherein said powered surgical instrument comprises (i) an elongated electrically conductive probe having a proximal end and a distal end and being attached at said proximal end thereof to said handle, said probe having formed in the interior thereof a longitudinally extending lumen communicating with said handle, said distal end of said probe having an aperture formed therethrough permitting said lumen to communicate with the exterior of said probe; (ii) an elongated drive shaft longitudinally disposed within said lumen extending from said proximal end of said probe to at least said aperture, said drive shaft being rotatably mounted within said lumen of said probe for rotation about the longitudinal axis of said drive shaft; and (iii) a cutting tool positioned on said drive shaft opposide said aperture of said probe, thereby to pass in close proximity to said aperture during each rotation of said shaft and sever any tissue of the patient urged against said exterior of said probe at said aperture;.

7. The method of claim 1, wherein said cutting step and said suctioning step occur concurrently.

8. A surgical instrument of a size and configuration for perforrning an ENT surgery, said system comprising a powered surgical instrument comprising: a handle; an elongated electrically conductive probe having a proximal end and a distal end and being attached at said proximal end thereof to said handle, said probe having formed in the interior thereof a longitudinally extending lumen communicating with said handle, said distal end of said probe having an aperture formed therethrough permitting said lumen to communicate with the exterior of said probe; an elongated drive shaft longitudinally disposed within said lumen extending from said proximal end of said probe to at least said aperture, said drive shaft being rotatably mounted within said lumen of said probe for rotation about the longitudinal axis of said drive shaft; a cutting tool positioned on said drive shaft opposide said aperture of said probe, thereby to pass in close proximity to said aperture during each rotation of said shaft and sever any tissue of the patient urged against said exterior of said probe at said aperture; and a cautery feature for selectively electrically cauterizing tissue of the patient contacting a preselected region on said exterior of said distal end of said probe.

9. The instrument of claim 8, wherein said probe comprises an insulating layer disposed on the exterior surface of said probe, wherein said insulating layer is configured to expose said preselected region.

10. The instrument of claim 8, wherein suction is applied to said lumen such that tissue may be cut, sucked through said aperture, directed through said lumen and transported out of said surgical instrument.

11. A method of performing a tonsillectomy comprising obtaining a powered surgical instrument comprising a cutting feature, a suction feature and a cautery feature; identifying tonsillar tissue to be removed at a surgical site; cutting said identified tonsillar tissue with said powered surgical instrument; suctioning said tonsillar tissue with said powered surgical instrument; and cauterizing tissue remaining at said surgical site after said cutting step.

12. A method of performing an adenoidectomy comprising obtaining a powered surgical instrument comprising a cutting feature, a suction feature and a cautery feature; identifying adenoid tissue to be removed at a surgical site; cutting said identified adenoid tissue with said powered surgical instrument; suctioning said identified adenoid tissue with said powered surgical instrument; and cauterizing tissue remaining at said surgical site after said cutting step.