WO2009048786A2

WO2009048786A2 - Palatal surgical apparatus and method of using same

Info

Publication number: WO2009048786A2
Application number: PCT/US2008/078583
Authority: WO
Inventors: Patrick C. Melder
Original assignee: Melder Patrick C
Priority date: 2007-10-08
Filing date: 2008-10-02
Publication date: 2009-04-16
Also published as: WO2009048786A3

Abstract

A palatal stapling apparatus (1) includes an instrument body (30) having proximal and distal end portions. A handle (31) at the proximal end portion enables a user to hold and manipulate the instrument body. A pair of spaced apart paddles are extending from a shaft (60) and include a staple paddle (10) and a tensioning paddle (90). The instrument body (30) provides a trigger (80) that moves between resting and firing positions. An actuator link moves between first and second positions, the actuator link being moved by the trigger (80), wherein the actuator link includes a staple moving member that is attached to the staple paddle (10). The staple paddle (10) and tensioning paddle (90) each may have an associated fastener bank (120, 120') that includes multiple fasteners components (121, 121'). The trigger (80), actuator link, and staple bank (120, 120') are configured to cause cooperating fastener components (121, 121') to engage one another surrounding targeted tissues when the trigger (80) is pulled. The staple paddle (10) and tensioning paddle (90) are also drawn together when the trigger (80) is pulled. A cutting member (100, 100') and crimping member (110, 110') may also be associated with at least one of the staple paddle (10) and tensing paddle (90).

Description

PALATAL SURGICAL APPARATUS AND METHOD OF USING SAME

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No.

60/978,265, filed October 8, 2007, the entirety of which is hereby incorporated by reference.

TECHNICAL FIELD [0002] The present invention relates to palatal surgery. More particularly, the present invention relates to a surgical tool that tenses, crimps, staples and cuts through selected tissue of the palate.

BACKGROUND ART

[0003] Obstructive sleep apnea is a common category of sleep-disordered breathing. It is caused by blockage of the airway, usually when the soft tissues in the back of the throat collapse during sleep. If left untreated, obstructive sleep apnea may result in health problems such as hypertension, stroke, heart failure, irregular heart rate, and heart attacks.

[0004] One method of surgical treatment for obstructive sleep apnea is uvulopalatopharyngoplasty, or UPPP, wherein airway obstructing tissues in the back of the throat are removed. UPPP may be employed as a standalone surgical intervention, or as one of the procedures in what is known as the Stanford Protocol.

[0005] When performing UPPP, or in the treatment of lesser maladies such as chronic snoring, palatal tissue is surgically excised. Amongst other tissues, the uvula, all or portions of the drooping mucosal web between the uvula and the posterior pillar, the soft palatal mucosa and/or submucosa may be removed.

[0006] Current surgical procedures for excising palatal tissues typically involve the tensing of palatal tissues with forceps, and the use of a scalpel, scissors, cautery or other known method to cut palatal tissues. After cutting the palatal tissue, cautery or similar means may be used to obtain hemostasis. The mucosal and muscular layers of the palate are then re-approximated with suture to help with hemostasis, healing, and pain control.

[0007] It is an object of the present invention to provide surgical instruments and associated surgical methods that crimp, cut, and suture or staple palatal tissues.

[0008] It is another object of the present invention to provide surgical instruments and associated surgical methods that excise palatal tissue in a more efficient and controlled manner.

[0009] It is yet another object of the present invention to provide surgical instruments and associated surgical methods that promote improved postoperative wound healing and decreased pain following closure of the palatal wound.

[0010] These and other objects and features of the present invention will become apparent in view of the present specification, drawings and claims. DISCLOSURE OF THE INVENTION

[0011] The present invention comprises a surgical instrument for palatal surgery. The surgical instrument includes a first paddle having a first crimping member, a second paddle having a second crimping member; and an actuator capable of moving at least one of the first paddle member and the second paddle member from a first position, wherein the first paddle member and the second paddle member are spaced apart, to a second position, wherein the first crimping member and the second crimping member are brought towards each other. The surgical instrument may further include a first cutting member associated with the first paddle. Moreover, the surgical instrument may further include a second cutting member associated with the second paddle.

[0012] In one embodiment, a first bank of staples is associated with the first paddle member. A second plurality of staples may likewise be associated with the second paddle member. Moreover, in one embodiment, both a cutting member and a staple bank are simultaneously associated with at least one of the first paddle and the second paddle, or with both of the first paddle and the second paddle. The staple banks include a plurality of staples which may, in an embodiment of the present invention, comprise resorbable staples.

[0013] In an alternative embodiment of the present invention, a multiple piece tissue fastener is employed instead of staples. A first component of the fastener is associated with the first paddle member, and a second component of the fastener is associated with the second paddle member. Bringing the paddles together causes a portion of the first component of the fastener to pierce tissue disposed between the first and second portions of the fastener, and to then be captured and held by the second component of the fastener, disposed on an opposing side of the pierced tissue. [0014] A shaft is disposed between a grasping region and the first and second paddles. A trigger is associated with and causes actuation of the actuator. A safety lock may be associated with the trigger to preclude its inadvertent operation. The cutting member may comprise a surgical blade, a cautery probe, an RF probe, or a laser scalpel.

[0015] The palatal surgical apparatus further includes a grasping region and, in a preferred embodiment, the first paddle and the second paddle are rotatable in orientation relative to the grasping region. A rotating collar disposed between the grasping region and the first and second paddles facilitates rotation of the paddles relative to the grasping region. The grasping region may comprise a portion of the body of the instrument. A uvular slot is disposed proximate at least one of the first paddle and the second paddle. Moreover, the surgical instrument may further include uvular grasping member, such as a uvular hook operably attached to a portion of the shaft proximate the uvular slot.

[0016] The present invention also comprises a method of excising palatal tissue. The method comprises the steps of: a) obtaining a palatal surgical instrument, the palatal surgical instrument comprising a first paddle having a first crimping member, a second paddle having a second crimping member, an actuator capable of moving at least one of the first paddle member and the second paddle member from a first position, wherein the first paddle member and the second paddle member are spaced apart, to a second position, wherein the first crimping member and the second crimping member are brought towards each other, a trigger associated with the actuator, a uvular slot, and a uvular grasping member; b) feeding at least a portion of a uvula of a patient through the uvular slot; c) grasping at least a portion of the uvula with the uvular grasping member; and d) pulling the trigger to, in turn, activate the actuator and draw the first paddle and the second paddle and, in turn, the first crimping member and the second crimping member towards each other. The first paddle and the second paddle may be rotated relative to the grasping region to accommodate a patient in at least one of a seated operative position and a supine operative position.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Additional characteristics and advantages of the invention will become apparent from the detailed description of preferred and other embodiments of the invention, which are illustrated only by way of non-limiting examples in the accompanying drawings wherein:

[0018] Fig. 1 of the drawings is an elevated perspective view of the present palatal stapler apparatus, including the paddle assembly shown in significantly enlarged form, relative to the instrument housing;

[0019] Fig. 2 of the drawings is an elevated view of a portion of the interior surface of the staple paddle, looking in an opposing direction relative to the position of the tensing paddle;

[0020] Fig. 3 of the drawings is an elevated view of a portion of the interior surface of the tensing paddle, looking in an opposing direction relative to the position of the staple paddle; and

[0021] Fig. 4 is a schematic diagram of the components of the trigger mechanism and the paddle actuator.

MODES FOR CARRYING OUT THE INVENTION

[0022] The present invention allows the surgeon to perform more precise cutting and suturing of palatal tissue for procedures on the palate for the treatment of snoring and/or sleep apnea, without the use of cautery to perform the surgery or suture to close the wound after the surgery. More particularly, the present invention relates to a palatal surgical apparatus that places surgical fasteners or staples in a patient's palatal tissue responsive to a trigger pull that tenses, crimps, staples and cuts through the selected tissue.

[0023] A preferred embodiment of the present palatal surgical apparatus 1 is shown in Fig. 1 as comprising paddle assembly 2, shaft 60, paddle actuator 3 (disposed at the junction of the paddles and shaft 60), uvular slot 40, uvular hook 50, collar 20, instrument body 30, safety lock 70 and trigger 80. Paddle assembly 2 comprises staple paddle 10, tensing paddle 90, and paddle actuator 3.

[0024] Instrument body 30 includes proximal handle or gripping region 31, distal arm 32, and curved region 33. Gripping region 31 enables a user to hold and manipulate the instrument body. In particular, gripping region 31 is configured to fit comfortably in an operator's palm, and to permit equal access to trigger 80 for both right handed and left handed operation.

[0025] Shaft 60 is elongated and includes proximal end 61 and distal end 62. Moreover, shaft 60 is rotatably attached to instrument body 30 proximate collar 20.

In particular, collar 20 is substantially frusto-conical in shape, and has internal threads that threadably engage cooperating external threads disposed on the distal surface of instrument body 30. Gripping members 21, which may comprise, for example, a series or ridges or a knurled surface disposed on the outer surface of collar 20, permit collar 20 to be rotated about an axis collinear to a longitudinal axis of shaft 60.

[0026] Rotating collar 20 in a first direction loosens shaft 60 relative to instrument body 30, permitting shaft 60 and, in turn, staple paddle 10 and tensing paddle 90, to be axially rotated relative to a longitudinal axis of distal arm 32. Rotating collar 20 in an opposing, second direction tightens shaft 60 relative to instrument body 30, holding shaft 60 and, in turn, staple paddle 10 and tensing paddle 90 in a selected axial orientation, relative to the longitudinal axis of distal arm 32.

[0027] In addition, rotating shaft 60 may optionally be slidably engaged with instrument body 30, permitting proximal end 61 of shaft 60 to be partially retracted within, or partially extended from, distal arm 32 to, in turn, adjust the distance of staple paddle 10 and tensing paddle 90 from instrument body 30. The overall length of palatal surgical apparatus 1 may accordingly be adjusted when collar 20 is loosened, and locked in place upon retightening collar 20.

[0028] In an alternative embodiment of the present invention, rotating shaft 60 may be permanently affixed to collar 20, which, in turn, is rotatably attached to distal arm 32 of instrument body 30. The rotational engagement of collar 20 and distal arm 32 preferably has sufficient tension to permit unwanted additional rotation, apart from manually turning collar 20 in order to achieve a desired degree of rotation of paddle assembly 2 relative to instrument body 30 and may optionally include periodic click- stops through the overall degree of relative rotation.

[0029] Trigger 80 includes arm 81, finger guard 82, and finger accepting region 83 disposed between finger guard 82 and arm 81. Pivoting joint 34 (fig. 4), carried within instrument body 30, pivotally attaches trigger 80 to instrument body 30. A spring or spring-biased member, carried within instrument body 30, biases trigger 80 to a normally open position, wherein arm 81 is distal from proximal gripping region 31. This spring bias may be overcome by placing a finger within finger accepting region 83 and manually applying sufficient pressure to pull arm 81 towards proximal gripping region 31, thus pivoting trigger 80 at pivoting joint 34 within instrument body 30.

[0030] Safety lock 70 may be employed by the operator to preclude an inadvertent and premature operation of trigger 80 and, in turn, paddle actuator 3. In particular, safety lock 70 includes curved, finger accepting region 71, arm 72, and pivot 73, pivotably attaching safety lock 70 to trigger 80. Cooperating recess 35 within instrument body 30 serves to accept and releasably retain a portion of safety lock 70 and maintain it in a deployed, first position until the surgeon is ready to activate trigger 80. Similarly, cooperating recess 84 within trigger 80 serves to accept and releasably retain a portion of safety lock 70 and maintain it in an undeployed, second position when the surgeon is ready to activate trigger 80.

[0031] Paddle assembly 2 has a closed position, wherein distal ends of staple paddle 10 and tensing paddle 90 are drawn towards each other, and an open position, wherein the distal ends of staple paddle 10 and tensing paddle 90 are in a spaced apart relationship, forming a gap therebetween. This gap between staple paddle 10 and tensing paddle 90 enables placement of the paddles on opposing sides of the tissue to be excised and stapled. [0032] Paddle actuator 3 serves to maintain staple paddle 10 and tensing paddle 90 in a spaced apart relationship whenever trigger 80 is in its non-actuated position (i.e., with arm 81 of trigger 80 spaced distally from and spring biased away from gripping region 31 of instrument body 30). Upon the actuation of trigger 80 (i.e., with arm 81 of trigger 80 drawn towards gripping region 31 of instrument body 30), paddle actuator 3 causes elongated distal edge 12 of staple paddle 10 and elongated distal edge 92 of tensing paddle 90 to be drawn towards each other.

[0033] The operation of the trigger and the paddle actuator are shown in schematic form in Fig. 4. Trigger 80 is coupled to pivoting joint 34, disposed within the interior of instrument housing 30. Spring or spring biased member 85 serves to maintain trigger 80 in a normally open position, with finger accepting region 83 spaced distally from the instrument housing. Paddle actuator 3 includes spring or biased member 135, coupled to proximal end 133 of tensing paddle 90, and to a more distal portion of staple paddle 10, as shown in Fig. 4. Actuator rod 130 is pivotally attached to trigger 80 at a proximal end 131. Distal end 132 of actuator rod 130 is attached to proximal ends of cables 136 and 137 forming a substantially Y-shaped connection. Distal ends of rods or cables 136 and 137 are operably coupled to proximal ends 133 and 134 of staple paddle 10 and tensing paddle 90, respectively. Spring 135 of paddle actuator 3 is coupled between staple paddle 135 and proximal end 133 of tensing paddle 90 and serves to maintain paddle assembly 2 in a normally open configuration. Upon the manual activation of trigger 80, the tension of spring 85 is overcome, and arm 81 pivots about pivoting joint 34, causing actuator rod 130 to move proximally, away from paddle assembly 2. This, in turn, places additional tension on cables or rods 136 and 137, overcoming the tension of spring 135 to, in turn, bring the distal edges 12 and 92 of staple paddle 10 and tensing paddle 90, respectively, towards each other. Releasing trigger 80 causes actuator rod 130 to move distally, towards paddle assembly 2. This, in turn, releases tension on cables or rods 136 and 137, allowing spring 135 to again separate distal edges 12 and 92 of staple paddle 10 and tensing paddle 90, respectively.

[0034] In one embodiment of the present invention, it is contemplated that both staple paddle 10 and tensing paddle 90 are movable, relative to shaft 60, and that paddle actuator 3 pivots both paddles relative to shaft 60. In another embodiment of the present invention, it is contemplated that one of staple paddle 10 and tensing paddle 90 is fixed relative to shaft 60, and that actuator 3 pivots the opposing paddle relative to the fixed paddle to draw the paddles together.

[0035] Uvular slot 40 is shown in Fig. 1 as comprising proximal curved end 41 and distal oblong end 42. Uvular slot 40 permits open communication between the interior of paddle assembly 2 and the exterior surface of shaft 60 proximate uvular hook 50. A substantially U-shaped member, uvular hook 50, includes first end 51, attached to shaft 60, and second, hooked end 52, extending outwardly from shaft 60 and substantially radially aligned with uvular slot 40, relative to a central longitudinal axis of shaft 60.

[0036] As shown in Fig. 1, elongated distal edge 11 of staple paddle 10, and a longitudinal axis of staple paddle 10, are both orthogonal to the longitudinal axes of shaft 60 and distal arm 32 of instrument body 30. Elongated distal edge 91 of tensing paddle 90, and a longitudinal axis of tensing paddle 90, are likewise both orthogonal to the longitudinal axes of shaft 60 and distal arm 32 of instrument body 30. [0037] In one embodiment of the present invention, two-piece or two-part surgical fasteners are employed, and are associated with single-use, replaceable fastener banks operably attached to the staple and tensing paddles. The individual multiple piece fasteners within the fastener banks may have a construction, for example, as that shown in U.S. Pat. No. 4,534,350, the entirety of which is hereby incorporated by reference, or that shown in U.S. Pat. No. 4,610,250, the entirety of which is hereby incorporated by reference. A first component of the fastener is associated with the first paddle member, and a second component of the fastener is associated with the second paddle member. Bringing the paddles together causes a portion of the first component of the fastener to pierce tissue disposed between the first and second portions of the fastener, and to then be captured and held by the second component of the fastener, disposed on an opposing side of the pierced tissue.

[0038] In another embodiment of the present invention, conventional surgical staples are employed instead of two-part surgical fasteners, and are associated with a single use, replaceable staple bank operably attached to the staple or tensing paddle. If a staple bank is operably attached to the staple paddle, the opposing surface of the tensing paddle comprises an elongated anvil, serving to drive the prongs of each individual deployed staple towards each other, in order to cinch each staple about the selected palatal tissue upon activation of the trigger to bring opposing inner surfaces of the staple and tensing paddles together. Similarly, if a staple bank is operably attached to the tensing paddle, the opposing surface of the staple paddle comprises an elongated anvil, serving to drive the prongs of each individual deployed staple towards each other. [0039] Staple paddle 10 is shown in further detail in Fig. 2 as comprising paddle body 11 having inner surface 14, elongated distal edge 12, cutting member 100, crimping strip 110, and fastener magazine, fastener bank or fastener cartridge 120. Fastener cartridge 120 is releasably attachable to a head region of staple paddle 10, and carries a predetermined number and arrangement of individual piercing or prong components

121 of the two-piece surgical fasteners. Prong components 121 may optionally be constructed of a resorbable material. Alternatively, prong components 121 may be constructed of a nonresorbable material, requiring their removal following healing of the surgical wound. As shown in Fig. 2, fastener cartridge 120, crimping strip 110, and cutting member 100 are all disposed proximate elongated distal edge 12 of staple paddle 10, and are all preferably substantially parallel to, and extending along a substantial portion of, the length of elongated distal edge 12. As a result, fastener cartridge 120, crimping strip 110, and cutting member 100 all have longitudinal axes substantially orthogonal to a longitudinal axis of shaft 60 (Fig. 1).

[0040] Tensing paddle 90 is shown in further detail in Fig. 3 as comprising paddle body 91 having inner surface 94, elongated distal edge 92, cutting member 100', crimping strip 110', and fastener magazine, fastener bank, or fastener cartridge 120'. Fastener cartridge 120' is releasably attachable to a staple head region of tensing paddle 90, and carries a predetermined number and arrangement of individual cooperating sockets or retaining components 121', each capable of receiving and retaining in place a corresponding prong component 121 of the staple paddle upon deployment of the prong component by activation of the trigger. As shown in Fig. 3, fastener cartridge 120', crimping strip 110', and cutting member 100' are all disposed proximate elongated distal edge 92 of tensing paddle 90, and are all preferably substantially parallel to, and extending along a substantial portion of the length of, elongated distal edge 92. As a result, fastener cartridge 120', crimping strip 110', and cutting member 100' all have longitudinal axes substantially orthogonal to a longitudinal axis of shaft 60 (Fig. 1).

[0041] As can be seen, the activation of paddle actuator 3 causes each prong component 121 to be dispensed from its associated cartridge 120, to pierce the selected palatal tissue disposed between the paddles, and for a portion of the prong component to be received by and retained within a corresponding retaining component 121', likewise dispensed from its associated cartridge 120', sandwiching the selected tissue between the dispensed prong component and the dispensed retaining component. At the same time, crimping strips 110 and 110', and cutting members 100 and 100', are drawn together. This, in turn, causes the contemporaneous crimping, stapling, and cutting of the selected palatal tissue.

[0042] The present invention may be manufactured and configured to any of a variety of specific sizes and dimensions in order to accommodate for the differing sizes and shapes of the soft palate of the general population. Moreover, specific designs may be configured to include curved paddles, and associated curved or otherwise nonlinear crimping strips, staple banks, and cutting members, in order to provide curved or otherwise nonlinear crimping, cutting and/or stapling for differing palatal surgical applications. For example, staple paddle 10 and tensing paddle 90 may be sized such that the their respective elongated distal edges 12 and 92, respectively, are between approximately 2.0 centimeters and 5.0 centimeters in length. As is apparent from the relative sizes of the paddles and instrument body depicted in Fig. 1, the paddles are shown significantly enlarged for clarity. [0043] Each cutting members 100, 100' may comprise, for example, a surgical blade, a cautery probe, a Radio Frequency (RF) probe, or a laser scalpel. When a cutting blade is employed as cutting members 100 and/or 100', the knife edge of the blade is elongated and extends parallel to, and substantially along the entire length of, elongated edges 12 and/or 92 of staple paddle 10 and/or tensing paddle 90, respectively.

[0044] The cautery probe may have a general construction similar to that disclosed in U.S. Pat. No. 4,196,734, the entirety of which is hereby incorporated by reference. When a cautery probe is employed as cutting members 100 and/or 100', the excising electrode or excising heating element of the cautery probe is elongated and extends parallel to, and substantially along the entire length of, elongated edges 12 and/or 92 of staple paddle 10 and/or tensing paddle 90, respectively. A sensor and/or a switch associated with trigger 80 senses when trigger 80 is pulled and energizes the cautery probe at that time.

[0045] The power source for the cautery probe(s) may comprise a rechargeable or replaceable battery carried within instrument body 30, or may comprise an external power source coupled to a power cable associated with instrument body 30. In either case, instrument body 30 contains the remainder of the electrical components associated with the cautery probe, apart from the electrode/heater and associated cabling extending through shaft 60 to paddle assembly 2.

[0046] The RF probe may have a general construction similar to that disclosed in U.S. Pat. No. 5,542,945, the entirety of which is hereby incorporated by reference. When an RF probe is employed as cutting members 100 and/or 100', the electrode pair and intermediate insulation layer of the RF probe are elongated and collectively extend adjacent each other and parallel to, and substantially along the entire length of, elongated edges 12 and/or 92 of staple paddle 10 and/or tensing paddle 90, respectively. A sensor and/or a switch associated with trigger 80 senses when trigger 80 is pulled and energizes the RF probe at that time.

[0047] The power source for the RF probe(s) may comprise a rechargeable or replaceable battery carried within instrument body 30, or may comprise an external power source coupled to a power cable associated with instrument body 30. In either case, instrument body 30 contains the remainder of the electrical components associated with the RF probe, apart from the two electrodes, intermediate insulation layer, and associated cabling extending through shaft 60 to paddle assembly 2.

[0048] The laser scalpel may have a general construction similar to that disclosed in U.S. Pat. No. 6,673,065, the entirety of which is hereby incorporated by reference. When a laser scalpel is employed as cutting members 100 and/or 100', the cutting members may each comprise an elongated optical outlet of an associated optical waveguide extending through the associated staple and/or tensing paddle from an associated source of coherent laser light. Alternatively, the cutting members may each comprise a plurality miniature lasers disposed proximate the distal tip of the staple or tensing paddle and arranged collinearly to form an elongated array of lasers. A sensor and/or a switch associated with trigger 80 senses when trigger 80 is pulled and energizes the laser scalpel at that time.

[0049] The power source for the laser scalpel(s) may comprise a rechargeable or replaceable battery carried within instrument body 30, or may comprise an external power source coupled to a power cable associated with instrument body 30. Moreover, the associated sources of coherent light may likewise either be contained within instrument body 30 or may comprise an external, coupled laser. In either case, instrument body 30 contains the remainder of the electrical and optical components associated with the laser scalpel.

[0050] Although, in the illustrated embodiment, a mechanical trigger is employed to activate and deactivate the paddle actuator to, in turn, articulate the paddle assembly, use of an electrical trigger switch or sensor is also contemplated by the present invention. The electrical trigger switch or sensor may be disposed on or proximate manual gripping region 31 and, when engaged by the operator, energizes a cautery probe, RF probe, or laser scalpel serving as cutting member 100 and/or 100'. At the same time, the electrical trigger energizes an electrical motor, servomotor, or electromagnet which is configured to operate paddle actuator 3 to draw staple paddle 10 and tensing paddle 90 together. Releasing or disengaging the electrical trigger switch or sensor by the operator de-energizes the cutting members and, at the same time, operates paddle actuator 3 to bring stable paddle 10 and tensing paddle 90 apart again.

[0051] In operation, when using the present palatal surgical apparatus, safety lock 70 is first extended into its engaged or locking position. The patient may be in either the supine or upright position, typically depending upon whether the apparatus is to be used in the operating room or clinic setting under local anesthesia, respectively. If the patient is in an upright operative position, collar 20 is employed to rotate shaft 60 to orient uvular slot 40 and uvular hook 50 in the cephalad position, with instrument body 30 and proximal gripping region 31 in the caudad position. If the patient is in a supine operative position, collar 20 is employed to rotate shaft 60 to orient uvular slot 40 and uvular hook 50 in the cephalad position, with instrument body 30 and proximal gripping region 31 likewise in the cephalad position. In either case, the paddles are configured with their elongated distal edges 12 and 92 aligned so that substantially aligned with a transverse plane of the head, upon insertion of the paddles through the mouth.

[0052] Next, the uvula of the patient is inserted and fed through uvular slot 40 to create uvular tension. As the uvula is tensed and fed through uvular slot 40, it is hooked onto hook end 52 of uvular hook 50, at any position along the uvula or soft palate as required to advance the desired amount of palatal tissue to be excised between staple paddle 10 and tensing paddle 90 and, specifically, beyond cutting members 100 and 100'. After appropriate positioning and tensing of the uvula, safety lock 70 is manually retracted to its disengaged position. Trigger 80 is then pulled to substantially simultaneously performing crimping, fastening and cutting of the palate.

[0053] In particular, as trigger 80 is pulled and paddles 10 and 90 of paddle assembly

2 are drawn together, crimping strips 110 and 110' come together to crimp a new leading edge of the palate, and to assist with hemostasis. As the palatal tissues are crimped between crimping strips 110 and 110', prong components 121 are dispensed from fastener cartridge 120, pierce the selected palatal tissue, and are received and retained by cooperating retaining components 121 ', which are likewise dispensed from fastener cartridge 120', locking together the two components of the surgical fastener together, with selected tissue captured therebetween. The final action after pulling trigger 80 is the cutting of the leading edges of the new palate, just distal to the crimped region, by cutting blades 100 and 100'. The excessive palatal and uvular tissues, now excised, remain held between staple paddle 10 and tensing paddle 90, and are removed by withdrawing the paddles from the patient's mouth. In this manner, excessive palatal tissue is removed without the need for cautery or suture ligation.

[0054] Although, in the previously described embodiment, a palatal surgical apparatus is disclosed that performs both cutting and stapling or fastening upon crimping, it is also contemplated that only one of these functions be performed by a specific instrument of the present invention. For example, a palatal stapling instrument is contemplated, wherein the cutting members described above are omitted from the paddle assembly, resulting in an instrument that crimps and fastens or staples palatal tissue, but does not cut or excise any palatal tissue. Moreover, a palatal cutting instrument is contemplated, wherein the fasteners or staples and associated fastener or staple cartridges described above are omitted from the paddle assembly, resulting in an instrument that crimps and cuts palatal tissue, but does not fasten or staple any palatal tissue.

[0055] The foregoing description and drawings merely explain and illustrate the invention and the invention is not limited thereto, except insofar as the following claims are so limited, as those skilled in the art will be able to make modifications and variations therein without departing from the scope of the invention.

Claims

What is claimed is:

1. A surgical instrument for palatal surgery, the surgical instrument comprising:

- a first paddle having a first crimping member; - a second paddle having a second crimping member; and

- an actuator capable of moving at least one of the first paddle member and the second paddle member from a first position, wherein the first paddle member and the second paddle member are spaced apart, to a second position, wherein the first crimping member and the second crimping member are brought towards each other.

2. The invention according to claim 1, further comprising a first cutting member associated with the first paddle.

3. The invention according to claim 2, further comprising a second cutting member associated with the second paddle.

4. The invention according to claim 1, further comprising a first bank of first fastening components associated with the first paddle member.

5. The invention according to claim 5, further comprising a second bank of second fastening components associated with the second paddle member.

6. The invention according to claim 1, further comprising at least one cutting member associated with at least one of the first paddle and the second paddle, and at least one fastener bank associated with at least one of the first paddle and the second paddle.

7. The invention according to claim 6, wherein the at least one cutting member comprises a first cutting member associated with the first paddle and a second cutting member associated with the second paddle.

8. The invention according to claim 6, wherein the at least one fastener bank comprises a first fastener bank associated with the first paddle and a second fastener bank associated with the second paddle.

9. The invention according to claim 6, wherein the at least one cutting member comprises a first cutting member associated with the first paddle and a second cutting member associated with the second paddle, and the at least one fastener bank comprises a first fastener bank associated with the first paddle and a second fastener bank associated with the second paddle.

10. The invention according to claim 1, further comprising a grasping region.

11. The invention according to claim 10, wherein the first paddle and the second paddle are rotatable in orientation relative to the grasping region.

12. The invention according to claim 10, further comprising a rotating collar disposed between the grasping region and the first and second paddles.

13. The invention according to claim 10, wherein the grasping region comprises a portion of a body portion of the instrument.

14. The invention according to claim 10, further comprising a shaft disposed between the grasping region and the first and second paddles.

15. The invention according to claim 1, further comprising a trigger associated with the actuator.

16. The invention according to claim 15, further comprising a safety lock associated with the trigger.

17. The invention according to claim 2, wherein the cutting member comprises a surgical blade.

18. The invention according to claim 2, wherein the cutting member comprises a cautery probe.

19. The invention according to claim 2, wherein the cutting member comprises an RF probe.

20. The invention according to claim 2, wherein the cutting member comprises a laser scalpel.

21. The invention according to claim 1, further comprising a uvular slot proximate at least one of the first paddle and the second paddle.

22. The invention according to claim 1, further comprising a uvular grasping member.

23. The invention according to claim 22, wherein the uvular grasping member comprises a hook proximate a uvular slot.

24. The invention according to claim 1, further comprising a resorbable staple associated with at least one of the first paddle and the second paddle.

25. The invention according to claim 1, further comprising:

- an elongated shaft coupled to the first paddle and the second paddle at a distal end of the shaft, the elongated shaft having a slot proximate the first paddle and the second paddle, the slot being sized to permit at least a portion of a uvula to be passed therethough, and a uvular hook proximate the slot; - an instrument body coupled to a proximal end of the shaft, the instrument body having a handle, a trigger, and a rotating collar disposed at the proximal end of the shaft;

- a first cutting member and a first bank of fastening components associated with the first paddle; and a second cutting member and a second bank of fastening components associated with the second paddle; wherein operation of the trigger actuates the actuator to, in turn, move at least one of the first paddle member and the second paddle member towards the other of the first paddle member and the second paddle member.

26. A method of excising palatal tissue, comprising the steps of:

- obtaining a palatal surgical instrument, the palatal surgical instrument comprising a first paddle having a first crimping member, a second paddle having a second crimping member, an actuator capable of moving at least one of the first paddle member and the second paddle member from a first position, wherein the first paddle member and the second paddle member are spaced apart, to a second position, wherein the first crimping member and the second crimping member are brought towards each other, a trigger associated with the actuator, a uvular slot, and a uvular grasping member;

- feeding at least a portion of a uvula of a patient through the uvular slot; - grasping at least a portion of the uvula with the uvular grasping member; and

- pulling the trigger to, in turn, activate the actuator and draw the first paddle and the second paddle and, in turn, the first crimping member and the second crimping member towards each other.

27. The method according to claim 26, wherein the palatal surgical instrument further comprises a grasping member and wherein the first paddle and second paddle are rotatable relative to the grasping member, further comprising the step of rotating the first paddle and the second paddle relative to the grasping region to accommodate a patient in at least one of a seated operative position and a supine operative position.

28. The method according to claim 26, wherein the palatal surgical instrument further comprises a first cutting member associated with the first paddle.

29. The method according to claim 28, wherein the palatal surgical instrument further comprises a second cutting member associated with the second paddle.

30. The method according to claim 26, wherein the palatal surgical instrument further comprises a first bank of fasteners associated with the first paddle member.

31. The method according to claim 32, wherein the palatal surgical instrument further comprises a second bank of fasteners associated with the second paddle member.

32. The method according to claim 26, wherein the palatal surgical instrument further comprises at least one cutting member associated with at least one of the first paddle and the second paddle, and at least one fastener bank associated with at least one of the first paddle and the second paddle.

33. The method according to claim 32, wherein the at least one cutting member comprises a first cutting member associated with the first paddle and a second cutting member associated with the second paddle.

34. The method according to claim 32, wherein the at least one fastener bank comprises a first fastener bank associated with the first paddle and a second fastener bank associated with the second paddle.

35. The invention according to claim 32, wherein the at least one cutting member comprises a first cutting member associated with the first paddle and a second cutting member associated with the second paddle, and the at least one staple bank comprises a first fastener bank associated with the first paddle and a second fastener bank associated with the second paddle.