Septal stapler apparatus

[0001] U.S. Provisional Patent Application No. 60/646,734, filed 25 Jan. 2005, and U.S. Provisional Patent Application No. 60/733,714, filed 4 Nov. 2005, are incorporated herein by reference. Priority of those applications is hereby claimed.

[0002] Not applicable

[0003] Not applicable

[0004] 1. Field of the Invention

[0005] The present invention relates to septal surgery. More particularly, the present invention relates to an improved septal stapler apparatus that places surgical staples in a patient's septal tissue responsive to a trigger pull that moves two elongated spaced apart appendages together, one pushing a staple toward the other and through the selected tissue.

[0006] 2. General Background of the Invention

[0007] The following U.S. Patent, which contain background information, are incorporated herein by reference:

[0008]

TABLE I
U.S. PAT. NO.	TITLE	ISSUE DATE
5,540,240	Intranasal Septal Fastener Driving	30 Jul. 1996
	Method
5,361,782	Intranasal Septal Stapling Method	8 Nov. 1994
5,370,294	Intranasal Septal Stapling Device	6 Dec. 1994
	and Method
6,283,121	Manual Pump and Ambu Bag	4 Sep. 2001
6,131,790	Surgical Stapler and Cartridge	17 Oct. 2000
5,351,871	Intranasal Septal Stapling Device	4 Oct. 1994
5,915,615	Tissue Fastening Device	29 Jun. 1999

[0009] The present invention provides an improved septal stapling apparatus that provides an instrument body having proximal and distal end portions. A handle at the proximal end portion enables a user to hold and manipulate the instrument body. A pair of spaced apart arms extend distally from the handle. The arms include a staple arm and a tensioning arm. There is a gap between the arms that enables placement of the arms on opposing sides of the tissue to be stapled.

[0010] The body provides a trigger that moves between resting and firing positions. The trigger moves an actuator link between first and second positions. The actuator link includes a staple moving member that is attached to the staple arm.

[0011] The staple arm has a staple bank that includes multiple staples. The trigger, actuator link, staple bank, and staple moving member are configured to move a staple to a stapling position when the trigger is pulled. The staple arm and tensioning arm move together when the trigger is pulled in order to place the staple in the selected tissue.

[0012] The present invention includes a septal stapling apparatus, having an instrument body with proximal and distal end portions. A handle at the distal end portion enables a user to hold and manipulate the instrument body.

[0013] A pair of spaced apart arms extends from the handle. The arms include a staple arm and a tensioning arm. The body has a trigger that moves between resting and firing positions. An actuator link moves between first and second positions, the actuator link being moved by the trigger. The actuator link includes a staple moving member that is attached to the staple arm.

[0014] The staple arm carries a staple bank that includes multiple staples. The trigger, actuator link, staple bank and staple moving member are configured to move a staple to stapling position when the trigger is pulled. The staple arm and tensioning arm move together when the trigger is pulled. Preferably, the tensioning arm has a receptacle that receives at least a part of a staple during stapling. Preferably, the tensioning arm pivots relative to the body during stapling.

[0015] The staple arm is preferably fixed relative to the body. The actuator preferably slides relative to the body. The actuator and staple moving member can be pivotally attached. The staple arm can house the staple magazine with a bank of staples therein. The actuator slides relative to the body and simultaneously causes the staple moving member to pivot, engaging and dispensing a staple from the staple magazine. Preferably, the staple arm and tensioning arm each have head portions that come together to dispense a staple when the trigger is pulled.

[0016] The handle fits comfortably in an operator's palm, and can permit equal access to the trigger from either side, i.e. either right hand or left hand operation. Emanating from the handle are the staple arm and the tensioning arm. These are of suitable dimensions to be inserted into a typical patient's nose, one arm into each nostril. At the end of the staple arm is the staple head which houses a bank of staples which are dispensed one-at-a-time.

[0017] The end of the tensioning arm can provide a recess for accommodating the heads of the staples as they are pushed from the staple head.

[0018] The tensioning arm moves so that the device can pass the relatively wide columella at the base of the nose between the nostrils but still gently come together on opposite sides of the relatively thin mucosal layers inside the nose which are to be stapled.

[0019] A handle cover and handle base can be fastened together (as with recessed Philips-head screws) to form the handle. The trigger slides within the handle, against the force of a trigger spring. The motion of the trigger causes the movement of the tensioning arm which pivots at the back of the handle cover.

[0020] Movement of the trigger also causes the translation of the actuator link by pivoting the trigger link about a fulcrum which protrudes from the inner surface of the handle base. The motion of the actuator link is transferred to the head link, causing one of the staples in the bank of staples to be dispensed from the staple head. The bank of staples are positioned by the staple advance rod which is moved by the advance rod spring being compressed between the body of the staple advance rod and the advance rod base.

[0021] The contoured shape of the tensioning arm mates with a projection or peg of the trigger. During the first part of the trigger's travel, the projection or peg pushes against the force of the tensioning arm spring to bring the tensioning arm into the proper position for stapling. The final portion of the trigger's travel acts to maintain the same position of the tensioning arm.

[0022] The trigger link moves and pivots, e.g. on a fulcrum on the inner wall of the handle base. When the bottom of the link is pressed by the trigger, the top moves the actuator link. The actuator link is retracted by the actuator spring.

[0050] FIGS. 1 and 6-20 show the preferred embodiment of the apparatus of the present invention designated generally by the numeral 10. Septal stapler apparatus 10 provides a tool body 11 having a proximal end portion 12 and a distal end portion 13. A trigger 14 is movably mounted to the tool body 11. The trigger 14 is used to activate the device when it is held by a user 48. A user 48 grips the tool body 11, depresses the trigger 14 in the direction of arrow 49 in FIG. 11, which then dispenses a staple 50 from staple bank 51 to the selected septal tissue layers 59, 60. FIGS. 2 and 3 show one embodiment of a single shaft staple 50 with one end pointed to facilitate membrane penetration. FIGS. 4 and 5 show a bank of staples 51 which is housed in the staple head 55. The bank of staples can be formed of any material. Polymeric staples, even absorbable ones, may be molded as a bank of staples by any number of processes, including injection molding, fused deposition, etc. Metal, ceramic or polymeric staples may be formed, cast, molded or machined individually and then adhesively attached together to form a bank of staples or loaded into the stapler body individually and held in a bank by friction at the surfaces.

[0051] A pair of arms are attached to the tool body 11. These include a moving arm 15 and a fixed arm 16. The moving arm 15 has a proximal end portion 17 and a distal end portion 18. The distal end portion 18 provides a receptacle 19 having a socket 20 that is receptive of an end portion (pointed section 42) of a staple 50 when the trigger 14 is depressed in the direction of arrow 49 in FIG. 11 and the moving arm 15 pivots in the direction of arrow 66 in FIG. 11 to meet the fixed arm 16 (see FIG. 14).

[0052] The moving arm 15 provides a contoured section 21 having a concavity 22 (see FIG. 12). This concavity 22 engages a camming surface 24 on projection or peg 23 of trigger 14 in the open position before the trigger 14 is depressed. When a user 48 depresses the trigger 14, the camming surface 24 of the projection 23 moves proximally (see arrow 56, FIG. 12), disengaging from the concavity 22 and thus rotating the moving arm 15 toward the fixed arm 16.

[0053] The trigger 14 is biased to return to a relaxed beginning position by compressive trigger spring 25. This trigger spring 25 can be mounted at its end portions on respective cylinders 26, 27. One of the cylinders 26 is mounted on the trigger 14. The other cylinder 27 is mounted on the tool body 11 (see FIGS. 6, 8, 9, and 13).

[0054] When the trigger 14 is depressed, lever 28 (FIGS. 6, 13) is rotated to push staple actuator link 34 in a distal direction. The lever 28 has a lower end portion 29 that is engaged by rod 57 on the rear surface of the trigger 14 when the trigger is depressed. The lever 28 rotates about fulcrum 30 so that its upper end portion 33 pushes the staple actuator link 34 distally. The central portion 31 of the link 28 engages the fulcrum 30. Upper end portion 33 of the lever 28 provides a transverse pin 32 that is mounted in slotted portion 40 provided at the proximal end 35 of staple actuator link 34.

[0055] Spring 37 connects at its end portions to hooks 38, 39. The hook 38 is attached to and travels with staple actuator link 34. The hook 39 is attached to the tool body 11. When the trigger 14 is depressed, lever 28 rotates so that the transverse pin 32 pushes the staple actuator link 34 in a distal direction.

[0056] Distal end portion 36 (FIG. 6) of actuator link 34 has a rectangularly shaped head 41 that engages a staple 50 to be placed in the selected tissue. The staple 50 is one of a plurality of staples that form a staple bank 51 (see FIGS. 2-5). The rectangularly shaped head 41 can be pivotally attached to the distal end 36 of the staple actuator link 34. The head 41 provides a transverse bar 43 (FIG. 6) that contacts the transverse beam 58 (FIG. 2) of staple 50 when the trigger 14 is depressed. The bar 43 of rectangular head 41 initially travels in a longitudinal slot 44 (FIG. 10), then curved slot 47, then in transverse slot 46. The longitudinal slot 44 and transverse slot 46 are connected with the curved transition slot section 47.

[0057] When the trigger 14 is depressed, the staple actuator link 34 (FIG. 14) moves distally, forcing the transverse bar 43 of rectangular head 41 to engage a staple 50 of staple bank 51. The transverse bar 43 engages the nearest staple 50 and pushes its pointed section 42 into the selected tissue 59, 60 (FIG. 18). The staple bank 51 is advanced using a staple advance rod 53 (FIGS. 6, 17). Rod 53 is urged in a distal direction with rod-advance spring 54. The advance rod 53 can provide an enlarged head 55 (FIGS. 6, 14) that is sized and shaped to contact and push staple bank 51.

[0058] FIGS. 8-18 show the interplay of the trigger 14 and the trigger link 28. FIG. 9 corresponds to the first part of the motion of trigger 14 (which moves the moving or tensioning arm 15, as in FIG. 6). FIGS. 9 and 13 show the point in the travel when the trigger 14 first contacts the trigger link 28. FIGS. 11, 17 and 18 show the full extent of the travel of the trigger 14, having pushed the bottom of the link 28 back, causing its upper end 33 to move forward, thus pushing the actuator link 34 forward.

[0059] FIG. 18 depicts the staple head at the distal end 13 portion of the arm 16 and partially broken away to show the locations of the bank 51 of staples 50, the head 41 and the actuator link 34.

[0060] FIGS. 10, 14, and 18 show views of the ends of the staple arm 16 and moving arm 15 during the process of dispensing a staple 50 from the bank 51 of staples and when joining two mucosal membrane layers 59, 60 or tissue flaps together with a staple 50. FIGS. 10 and 14 represent the pre-stapled state, after the cartilage and bone are removed during the septoplasty operation. FIG. 14 represents the state after the first stage of trigger 14 actuation when the arm 15 moves to bring the two membranes 59, 60 into contact. FIG. 18 represents the state after complete trigger 14 actuation when the lead staple 50 penetrates the two membranes 59, 60. After the trigger 14 is released, leaving the staple 50 holding the two membranes 59, 60 together, the arms 15, 16 return to the starting position of FIGS. 7-10.

[0061] The present invention encompasses other mechanisms for imparting the necessary driving force to a staple within the geometrical constraints of a typical nasal passageway, in addition to a compression linkage. A description of three of these alternate embodiments or mechanisms follows with reference to FIGS. 21-26. Each may be housed within a chassis similar to that envisioned for the compression linkage, namely an arm carrying a bank of staples opposite an arm with a staple receptacle.

[0062] The first embodiment variant 61 (FIG. 21) is based on magnetic or electromagnetic principles, whereby the force to move staples 50 is provided by a magnetic field at magnet 62. The magnet 62 can be either permanent, e.g., a rare earth magnet, or induced by an electric current, e.g., a solenoid. FIGS. 21 and 22 show staples 50 being sequentially acted upon by an actuating member, such as plunger 65, or a bar, link, or the like, which moves in relation to arm 16 which holds the staples 50 in the ready position as with the preferred embodiment. A moving arm 15 moves into proximity of the staple 50 and carries a magnetic field e.g. magnet 62. Arm 15 can be made either completely or partially from magnetic material and/or contain an electromagnet coil. The magnetic attraction pulls the actuating arm member 15 to arm 16, causing the staple 50 to fire into the membranes 59, 60 to be stapled. After firing, the magnetic force on the actuating member is diminished through moving the arm 15 away from arm 16 and/or turning off the electromagnet 62. FIGS. 21 and 22 show external representations of the arms 15, 16 and how the actuating member (e.g. plunger 65) may be held in, and returned to, the ready position by an actuator return spring 64 (leaf, tension, or compression). FIG. 21 shows a leaf spring 64 supporting the actuating member 65 in the ready position. FIG. 22 shows the actuating member 65 in the actuated position, i.e., at the end of a staple stroke, wherein the magnetic force of the swing arm overcomes the lesser restraining force of the leaf spring 64 to pull the plunger 65 and dispense staple 50. Once the magnetic force is diminished, the actuating member or plunger 65 returns to the position shown in FIG. 21 under the action of the leaf spring 64.

[0063] An additional variant, depicted in FIGS. 23 and 24, is based on the rotation of shaft 67 and cam 68 which presses on the head of the staple 50 to be fired. The rotation of the cam 68 can be caused by the torsional twist of attached shaft 67. FIG. 23 shows the cam 68 in the un-actuated position in contact with the staple 50 to be fired from the bank 51 of staples. FIG. 24 shows the same staple 50 being displaced by the movement of the cam 68 due to the twist of the torsion shaft 67. The twist of the shaft 67 can be induced from the linear or angular motion of a trigger 114 using gears, linkages, bearings, and/or the like. FIG. 24 shows a bearing surface fixed to a trigger 114 pushing a helix-shaped bearing surface 72 on the surface of a torsional cylinder 69. FIGS. 23 and 24 show details of the bearing interaction between peg 70 on the translating trigger 114 and the rotating cylinder 69. A torsional spring 71 provides the constraint to return the cam 68 and shaft 67 to the un-actuated position against the motion of the trigger 114.

[0064] Another variant shown in FIGS. 25 and 26 and designated by the numeral 73 is configured to fire staples utilizing the resultant force from pressurizing a cavity. This can be accomplished with either a gas (e.g., air for a pneumatic device) or a liquid (e.g., water for a hydraulic device). The cavity 74 can be the space adjacent the staple 50, sealed with a translating surface (e.g., a piston), an expanding bladder (e.g., a balloon or diaphragm), or combination of the two. The liquid or gas system can either be closed or open. An open system would vent the pressurized medium when the staple exits, e.g., through an orifice normally sealed by a staple. A closed system, such as the embodiment depicted in FIGS. 25 and 26, would use the motion of a trigger to push water down a pressurization tube 75 and expand an elastic balloon 76 into a volume which displaces the staple to be fired from the staple bank 51. FIG. 25 shows the balloon 76 in the ready, contracted state. FIG. 26 shows the balloon 76 in the inflated, stapling state.

[0065] It should be understood that the staple 50 can be any shape that will be passed through the mucosal bilayer of the nasal septum and may include cartilage between the mucosal layer. This staple 50 will pull the mucosal layers in proximity preventing the formation of a hematoma. The staple 50 will preferably be made of an absorbable material such as polyglycolic acid (PGA) or polylactic acid (PLA) or may be made as a combination of copolymers.

[0066] The stapler and staples may be produced and packaged in a sterile environment or sterilized before use. A range of options is available and the choice will depend in part on the particular component materials employed. Irradiation, as with gamma rays or electron beams, can be used assuming all components are compatible, particularly component rubbers and plastics. Exposure to sterilizing gasses, such as ethylene oxide, may be used, as long as component plastics do not retain amounts which exceed accepted levels. Likewise, liquids may also be used, such as those containing glutaraldehyde, in accordance with accepted standards.

[0067] The present invention can also include a nasal spray which facilitates the absorption of the staple polymer. The spray is preferably made of ingredients that will maintain moisture in the nasal cavity such as saline, but will also be formulated to increase degradation of the staple 50 which may include either a base or acid, an enzyme such as pepsin, or the formulation may be hypertonic to pull moisture into the nasal cavity. The nasal spray is preferably used around 6-8 times per day for 4-6 weeks (or until the staples 50 are completely absorbed).

[0068] The following is a list of parts and materials suitable for use in the present invention:

[0069]

Part
Number	Description
10	septal stapler apparatus
11	tool body (unfilled or filled plastic such as ABS, PVC,
	polypropylene, polyester or polycarbonate, or metal
	such as aluminum, stainless steel, or titanium -
	e.g. 7-15 cm long, 2-6 cm high, and 2-5 cm wide)
12	proximal end portion
13	distal end portion
14	trigger (unfilled or filled plastic such as ABS, PVC,
	polypropylene, polyester or polycarbonate, or metal such
	as aluminum, stainless steel, or titanium - e.g. 1-5 cm
	long, 1-4 cm high, and 1-4 cm wide)
15	moving or tensioning arm (unfilled or filled plastic such
	as ABS, PVC, polypropylene, polyester or polycarbonate,
	or metal such as aluminum, stainless steel, or titanium -
	e.g. 5-16 cm long, 2-8 mm high, and 1-5 mm wide)
16	fixed arm (unfilled or filled plastic such as ABS, PVC,
	polypropylene, polyester or polycarbonate, or metal such
	as aluminum, stainless steel, or titanium - e.g. 5-16 cm
	long, 2-8 mm high, and 1-5 mm wide)
17	proximal end portion
18	distal end portion
19	receptacle
20	socket
21	contoured section
22	concavity
23	projection
24	camming surface
25	trigger spring (such as model no. C0240-020-2000-S
	produced by Associated Spring Raymond, a subsidiary
	of Barnes Group, Inc. of 1705 Indian Wood Circle,
	Maumee, OH 43537, US)
26	cylinder
27	cylinder
28	lever (unfilled or filled plastic such as ABS, PVC,
	polypropylene, polyester or polycarbonate, or metal such
	as aluminum, stainless steel, or titanium - e.g. 1-2 cm
	long, 1-4 mm high, and 1-4 mm wide)
29	lower end portion
30	fulcrum
31	central portion
32	transverse pin
33	upper end portion
34	staple actuator link (unfilled or filled plastic such as
	ABS, PVC, polypropylene, polyester or polycarbonate, or
	metal such as aluminum, stainless steel, or titanium -
	e.g. 5-16 cm long, 2-8 mm high, and 1-5 mm wide)
35	proximal end
36	distal end
37	spring (such as model no. E0063-007-0250-S
	produced by Associated Spring Raymond, a subsidiary of
	Barnes Group, Inc. of 1705 Indian Wood Circle, Maumee,
	OH 43537, US)
38	hook
39	hook
40	slotted portion
41	rectangular head (unfilled or filled plastic such as
	ABS, PVC, polypropylene, polyester or polycarbonate,
	or metal such as aluminum, stainless steel, or titanium -
	e.g. 3-8 mm long, 3-8 mm wide, and 0.5-1.5 mm thick)
42	pivotal connection
43	transverse bar
44	longitudinal slot
46	transverse slot
47	curved slot section
48	user
49	arrow
50	staple (bio-absorbable polymers or copolymers such as
	polyglycolic acid (PGA), polylactic acid (PLA),
	polydioxanone, polycaprolactone, polyhydroxybutyrate,
	polyester, or other polymer such as PVC, polypropylene,
	or polycarbonate, or metal such as aluminum, stainless
	steel, or titanium - e.g. 2-6 mm long and 0.5-2.5 mm
	thick)
51	staple bank
52	pointed section
53	staple advance rod (unfilled or filled plastic such as
	ABS, PVC, polypropylene, polyester or polycarbonate,
	or metal such as aluminum, stainless steel, or titanium -
	e.g. 4-10 cm long, 0.5-5 mm high, and 0.5-5 mm wide)
54	advance rod spring (such as model no. C0057-006-0310-S
	produced by Associated Spring Raymond, a subsidiary of
	Barnes Group, Inc. of 1705 Indian Wood Circle, Maumee,
	OH 43537, US)
55	enlarged head
56	arrow
57	rod
58	transverse beam
59	mucosal membrane layer
60	mucosal membrane layer
61	septal stapler apparatus
62	magnet
64	leaf spring (unfilled or filled plastic such as ABS, PVC,
	polypropylene, polyester or polycarbonate, or metal such
	as aluminum, stainless steel, or titanium - e.g. 1-10 mm
	long, 0.1-2 mm high, and 0.1-2 mm wide)
65	plunger (a magnetic material containing such substances
	as iron, nickel, cobalt, wairauite, magnetite, oxides,
	or sulfides in whole or in part)
66	variant with cam
67	shaft (unfilled or filled plastic such as ABS,
	PVC, polypropylene, polyester or polycarbonate,
	or metal such as aluminum, stainless steel, or
	titanium - e.g. 5-16 cm long, 2-4 mm
	diameter,)
68	cam (unfilled or filled plastic such as ABS, PVC,
	polypropylene, polyester or polycarbonate, or metal
	such as aluminum, stainless steel, or titanium -
	e.g. 3-8 mm long, 0.5-2 mm thick, and 0.5-2 mm
	wide)
69	cylinder (unfilled or filled plastic such as ABS, PVC,
	polypropylene, polyester or polycarbonate, or metal
	such as aluminum, stainless steel, or titanium -
	e.g. 1-3 cm long, 1-2 cm diameter)
70	peg
71	torsional spring
72	bearing surface
73	variant with pressure
74	cavity
75	pressurization tube
76	balloon (an elastic material such as rubber, latex or
	silicone)
77	cavity
114	trigger (unfilled or filled plastic such as ABS, PVC,
	polypropylene, polyester or polycarbonate, or metal such
	as aluminum, stainless steel, or titanium - e.g. 1-5 cm
	long, 1-4 cm high, and 1-4 cm wide)

[0070] All measurements disclosed herein are at standard temperature and pressure, at sea level on Earth, unless indicated otherwise. All materials used or intended to be used in a human being are biocompatible, unless indicated otherwise.

[0071] The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.