Clip-over disposable assembly for use with hemostat-style surgical instrument and methods of manufacturing same

Abstract

A clip-over disposable assembly includes a switch assembly and a disposable body. The disposable body includes a first disposable member, a second disposable member including first and second wall portions, and a third disposable member. The first wall portion defines a first aperture therethrough and a first cavity configured to receive therein a first portion of the switch assembly. The third disposable member includes a third wall portion, wherein a body of the second disposable member and the third wall portion define an opening configured to allow a shaft of a hemostat-style surgical instrument to pass therethrough. The second wall portion and the third wall portion cooperatively define a chamber in communication with the opening and configured to receive therein at least a portion of the shaft of the hemostat-style surgical instrument, wherein the at least a portion of the shaft is received in the chamber from an off-axis position.

Claims

1. A surgical instrument, comprising: a hemostat-style device, including: first and second shaft members each defining a proximal end and a distal end; first and second handle members disposed at the proximal ends of the respective first and second shaft members; first and second jaw members extending distally from the distal ends of the respective first and second shaft members; and a pivot interconnecting the first and second shaft members towards the distal ends thereof such that movement of the first and second handle members between an open position and a closed position moves the first and second jaw members between a spaced-apart position and an approximated position for grasping tissue therebetween; and a clip-over assembly, including: an elongated body including first and second side walls interconnected by a base wall so as to define a U-shaped configuration, the first and second side walls and the base wall cooperating to define a U-shaped chamber configured to receive the first shaft member of the hemostat-style device and releasably engage the first shaft member therein; and at least one actuator operably disposed on at least one of the first or second side walls of the elongated body and positioned such that, with the first shaft member releasably engaged within the elongated body, the first shaft member is disposed on one side of the at least one actuator and the second shaft member is disposed on a second, opposite side of the at least one actuator.

2. The surgical instrument according to claim 1, wherein the at least one actuator includes first and second actuators operably disposed on the respective first and second side walls of the elongated body of the clip-over assembly.

3. The surgical instrument according to claim 1, wherein at least a portion of each of the first and second shaft members is formed from an electrically-conductive material.

4. The surgical instrument according to claim 3, wherein the elongated body of the clip-over assembly is formed from an electrically-insulative material.

5. The surgical instrument according to claim 1, wherein the elongated body of the clip-over assembly includes a proximal portion having the at least one actuator operably disposed thereon and an elongated distal portion extending distally from the proximal portion.

6. The surgical instrument according to claim 5, wherein, when the elongated body of the clip-over assembly is engaged about the first shaft member, at least a portion of the second shaft member is disposed between the first and second side walls of the elongated distal portion of the elongated body.

7. The surgical instrument according to claim 1, wherein the elongated body of the clip-over assembly is formed via injection molding.

8. The surgical instrument according to claim 1, wherein the at least one actuator includes an electrical switch.

9. The surgical instrument according to claim 8, wherein, when the elongated body of the clip-over assembly is engaged about the first shaft member, the electrical switch is selectively actuatable to supply energy to at least one of the first and second jaw members.

10. The surgical instrument according to claim 1, wherein the at least one actuator includes a joystick.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Objects and features of the presently-disclosed clip-over disposable assembly for use with a hemostat-style surgical instrument and methods of manufacturing a clip-over disposable assembly will become apparent to those of ordinary skill in the art when descriptions of various embodiments thereof are read with reference to the accompanying drawings, of which:

(2) FIG. 1 is a side view of a bipolar forceps in accordance with an embodiment of the present disclosure;

(3) FIG. 2 is an enlarged, cross-sectional view taken along line 2-2 of FIG. 1;

(4) FIG. 3 is a top view of a switch assembly in accordance with an embodiment of the present disclosure;

(5) FIG. 4 is a side view of the switch assembly of FIG. 3 in accordance with an embodiment of the present disclosure;

(6) FIG. 5 is a flowchart illustrating a method of manufacturing a clip-over disposable assembly in accordance with an embodiment of the present disclosure; and

(7) FIG. 6 is a flowchart illustrating a method of manufacturing a clip-over disposable assembly in accordance with another embodiment of the present disclosure.

DETAILED DESCRIPTION

(8) Hereinafter, embodiments of the presently-disclosed clip-over disposable assembly for use with a hemostat-style surgical instrument and methods of manufacturing a clip-over disposable assembly are described with reference to the accompanying drawings. Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and as used in this description, and as is traditional when referring to relative positioning on an object, the term “proximal” refers to that portion of the apparatus, or component thereof, closer to the user and the term “distal” refers to that portion of the apparatus, or component thereof, farther from the user.

(9) As it is used in this description, “transmission line” generally refers to any transmission medium that can be used for the propagation of signals from one point to another.

(10) Various embodiments of the present disclosure provide electrosurgical instruments suitable for sealing, cauterizing, coagulating/desiccating and/or cutting vessels and vascular tissue. Embodiments may be implemented using electromagnetic radiation at microwave frequencies or at other frequencies.

(11) Various embodiments of the presently-disclosed electrosurgical instrument including a hemostat-style surgical instrument and a clip-over disposable assembly are suitable for use with open and/or laparoscopic surgical procedures. Although the following description describes the use of a bipolar forceps, the teachings of the present disclosure may also apply to a monopolar forceps, or other suitable type of hemostat-style surgical instrument.

(12) FIG. 1 shows a bipolar forceps 10 according to an embodiment of the present disclosure that includes a mechanical forceps 20 and a clip-over assembly 50. Clip-over assembly 50 is configured to accommodate a switch assembly 100, partly shown by phantom lines in FIG. 1. An embodiment of a switch assembly, such as the switch assembly 100 of FIG. 1, in accordance with the present disclosure, is shown in more detail in FIGS. 3 and 4. It will be understood, however, that other switch assembly embodiments may also be used. Clip-over assembly 50, which is described in more detail later in this disclosure, is generally configured to be releaseably attachable to the mechanical forceps 20.

(13) Mechanical forceps 20 includes first and second members 9 and 11. First and second members 9 and 11 each include an elongated shaft 12 and 14, respectively. Shafts 12 and 14 each include a proximal end 13 and 15 and a distal end 17 and 19, respectively. Each proximal end 13, 15 of each shaft portion 12, 14 includes a handle member 16 and 18, respectively, attached thereto to allow a user to effect movement of at least one of the shaft portions 12 and 14 relative to one another. Extending from the distal end 17 and 19 of each shaft portion 12 and 14 are end effectors 22 and 24, respectively. End effectors 22 and 24 are movable relative to one another in response to movement of the handle members 16 and 18.

(14) In some embodiments, as shown in FIG. 1, shaft portions 12 and 14 are affixed to one another at a point proximate the end effectors 22 and 24 about a pivot 25 such that movement of the handle members 16 and 18 impart movement of the end effectors 22 and 24 from an open configuration, wherein the end effectors 22 and 24 are disposed in spaced relation relative to one another, to a clamping or closed configuration, wherein the end effectors 22 and 24 cooperate to grasp tissue therebetween. In alternative embodiments not shown, the forceps 10 can be designed such that movement of one or both of the handle members 16 and 18 will only cause one of the end effectors, e.g., 22, to move with respect to the other end effector, e.g., 24.

(15) End effector 24 generally includes an upper or first jaw member 44. End effector 22 generally includes a second or lower jaw member 42. In some embodiments, shaft members 12 and 14 of the mechanical forceps 20 may be designed to transmit a particular desired force to opposing inner-facing surfaces of the jaw members 42 and 44.

(16) Examples of shaft member and end effector embodiments are disclosed in commonly assigned U.S. Pat. No. 6,277,117 entitled “OPEN VESSEL SEALING FORCEPS WITH DISPOSABLE ELECTRODES”, commonly assigned U.S. Pat. No. 6,796,981 entitled “VESSEL SEALING SYSTEM”, commonly assigned U.S. Pat. No. 7,510,556 entitled “VESSEL SEALING INSTRUMENT”, and commonly assigned U.S. patent application Ser. No. 11/232,174 filed on Sep. 21, 2005, entitled “MECHANISM FOR DIVIDING TISSUE IN A HEMOSTAT-STYLE INSTRUMENT”.

(17) Forceps 10 includes a cable assembly 62 configured to operably couple the forceps 10 to an electrosurgical power generating source 28, e.g., a microwave or RF electrosurgical generator. Cable assembly 62 may be formed from a suitable flexible, semi-rigid or rigid cable, and may connect directly to the electrosurgical power generating source 28. In some embodiments, the cable assembly 62 connects the forceps 10 to a connector 63, which further operably connects the instrument 10 to the electrosurgical power generating source 28. Cable assembly 62 may be internally divided into a plurality of conductors (e.g., 61a, 61b, 61c shown in FIG. 2) configured to transmit electrosurgical energy through respective feed paths to the end effectors 22 and 24 and/or transmitting electrical signals to control delivery of electrosurgical energy and/or feedback signals to control the electrosurgical power generating source 28.

(18) Electrosurgical power generating source 28 may include any energy source, e.g., electrosurgical generator, suitable for use with electrosurgical devices, and may be configured to provide ultrasound, radiofrequency (RF), microwaves, laser energy and/or various frequencies of electromagnetic energy. Examples of electrosurgical generators that may be suitable for use as a source of electrosurgical energy are commercially available under the trademarks FORCE EZ™, FORCE FX™, SURGISTAT™ II, and FORCE TRIAD™ offered by Covidien. Cable assembly 62 may additionally, or alternatively, provide a conduit (not shown) configured to provide coolant fluid from a coolant source (not shown) to one or more components of the forceps 10. Forceps 10 may alternatively be configured as a wireless device and/or battery powered.

(19) As shown in FIGS. 1 and 2, clip-over assembly 50 is designed to work in combination with the mechanical forceps 20. Clip-over assembly 50 is designed to clip around the mechanical forceps 20 from the side and includes a disposable body 56 configured to releaseably engage one of the shaft members, e.g., 14, of the mechanical forceps 20. In some embodiments, as shown in FIG. 2, disposable body 56 includes a first disposable member 57, a second disposable member 58 and a third disposable member 59, wherein the second disposable member 58 is coupled to the first disposable member 57 to cooperatively define a tab portion 53, and the third disposable member 59 is coupled to the first disposable member 57 to cooperatively define a chamber “C”, wherein the chamber “C” is disposed in communication with an opening “O” defined by the second disposable member 58 and the third disposable member 59. Tab portion 53 is configured to accommodate the switch assembly 100 therein and suitably shaped to fit within the region “R” (FIG. 1) defined between the opposing shaft portions 12 and 14.

(20) First disposable member 57, the second disposable member 58 and/or the third disposable member 59 may include a plurality of mechanical interfaces disposed at various positions along their respective interiors to effect mechanical engagement with one another. In some embodiments, either male or female mechanical interfaces or a combination of mechanical interfaces may be disposed within the second disposable member 58 and/or the third disposable member 59 with mating mechanical interfaces disposed on or within the first disposable member 57. First disposable member 57, second disposable member 58 and the third disposable member 59 may be assembled together with the aid of alignment pins, detents, snap-like interfaces, tongue and groove interfaces, locking tabs, adhesive ports, etc., utilized either alone or in combination for assembly purposes. Any suitable joining method may be used to attach (or clip, connect, couple, fasten, secure, etc.) the second and third disposable members 58, 59 to the first disposable member 57. In alternative embodiments not shown, the first disposable member 57 and the third disposable member 59 are integrally formed as a single unitary body by a suitable molding process, such as injection molding.

(21) First disposable member 57, the second disposable member 58, and the third disposable member 59 may be formed in whole or in part of any suitable electrically non-conductive material, e.g., a suitable polymeric or ceramic material. In some embodiments, the first disposable member 57, the second disposable member 58 and/or the third disposable member 59 are formed at least in part from a rigid material, such as polyamide or other plastic, or a composite material having low electrical conductivity, e.g., glass-reinforced polymers. In some embodiments, the first disposable member 57, the second disposable member 58 and/or the third disposable member 59, or portions thereof, may be formed from metal, thermoplastic, e.g., polycarbonate, composites, e.g., plastic-metal or ceramic-metal composites, or other materials.

(22) As shown in FIG. 2, first disposable member 57 includes a first wall portion 51 and a second wall portion 52. First wall portion 51 defines a first aperture 71 therethrough and a first cavity 76 associated with the first aperture 71. First cavity 76 is configured to receive therein a first portion (e.g., 46 shown in FIGS. 2 and 4) of the switch assembly 100. Second disposable member 58 includes a body 54 defining a second aperture 74 therethrough and a second cavity 78 associated with the second aperture 74. Second cavity 78 is configured to receive therein a second portion (e.g., 48 shown in FIGS. 2 and 4) of the switch assembly 100. Third disposable member 59 includes a third wall portion 55. Third wall portion 55 of the third disposable member 59 and the body 54 of the second disposable member 58 are adapted to cooperatively define an opening “O” configured to allow one of the shaft members, e.g., 14, of the mechanical forceps 20 to pass therethrough. Third wall portion 55 of the third disposable member 59 and the second wall portion 52 of first disposable member 57 are adapted to cooperatively define a chamber “C” configured to receive therein at least a portion of one of the shaft members, e.g., 14, of the mechanical forceps 20, wherein chamber “C” is disposed in communication with the opening “O”. In some embodiments, at least a portion of the cable assembly 62 is housed within the clip-over assembly 50.

(23) Although the clip-over assembly 50 is adapted to releaseably-engage the mechanical forceps 20, bipolar forceps 10 can be manufactured wherein the clip-over assembly 50 may be permanently or semi-permanently affixed to the mechanical forceps 20 by any suitable process including without limitation mechanical fasteners, grooves, flanges, adhesive bonding, welding processes, e.g., laser welding, mechanical interlock, snaps, bent tabs, or other suitable joining method may be used to attach (or clip, connect, couple, fasten, secure, etc.) the clip-over assembly 50 to the mechanical forceps 20.

(24) As cooperatively shown in FIGS. 1 and 2, switch assembly 100 includes a user-actuatable button “B” including two user-accessible contact areas 4a and 4b (e.g., disposed on opposite sides of the mechanical forceps 20) configured to allow finger actuation of a switch “S”. Switch “S” may include any suitable switch, e.g., a joystick switch or other control mechanism, and may be disposed in operative communication with a source of electrosurgical energy 28 and/or a processor unit (not shown) configured to control delivery of electrosurgical energy to the forceps 10.

(25) In some embodiments, as shown in FIGS. 3 and 4, contact areas 4a and 4b may include one or more features, e.g., protrusions or contact bumps 41 raised on the face of the contact areas 4a and 4b, to increase operability and/or enhance ease-of-use of the button “B”. The shape, size and spacing of individual contact bumps 41 may be varied from the configuration depicted in FIGS. 3 and 4.

(26) As shown in FIGS. 3 and 4, switch assembly 100 includes a connector member 30 adapted to operably couple the button “B” and the switch “S”. Connector member 30 includes a post member “P” operably associated between the button “B” and the switch “S”. As shown in FIG. 3, post member “P” includes a post body 32 including two prong-like portions 34 and 36 extending outwardly from the connector member 30. Connector member 30 includes a first connector portion 31 disposed to place the contact areas 4a and 4b in operative association with the post body 32, and may include a second connector portion 33 disposed to place the post body 32 in operative association with the switch “S”. In some embodiments, the post body 32 bisects or otherwise divides the connector member 30 into the first connector portion 31 and the second connector portion 33.

(27) In some embodiments, button “B” includes a flange 45 disposed in association with the first and second contact areas 4a and 4b. Flange 45 is configured to facilitate positioning of the button “B”, and may be adapted to reduce fluid egress, e.g., to reduce the likelihood of damage to the switch “S” due to fluid egress. In some embodiments, flange 45 is configured to facilitate positioning of the first user-accessible contact area 4b relative to the first aperture 71 and positioning of the second user-accessible contact area 4a relative to the second aperture 74.

(28) As shown in FIG. 3, connector portion 30 defines a first axis “A.sub.1-A.sub.1” along the longitudinal direction of the connector portion 30, and a transverse or second axis “A.sub.2-A.sub.2” perpendicular thereto. Post body 32 defines a third axis “A.sub.3-A.sub.3” along the longitudinal direction of the post body 32, wherein the third axis “A.sub.3-A.sub.3” is at least substantially parallel to the second axis “A.sub.2-A.sub.2”. Button “B” is selectively actuatable by depression of one or both of the contact areas 4a, 4b to cause movement of the post body 32 relative to the second axis “A.sub.2-A.sub.2”, which, in turn, allows selective activation of the switch “S”.

(29) In some embodiments, switch assembly 100 is adapted to preclude activation of the switch “S” if the applied force to one or both of the contact areas 4a, 4b does not result in deflection of the third axis “A.sub.3-A.sub.3” by at least a predetermined angle (e.g., relative to the second axis “A.sub.2-A.sub.2”), e.g., to avoid or reduce unintended activation of the switch “S”. In some embodiments, when user-applied force to one or both of the contact areas 4a, 4b causes movement of the first connector portion 31 resulting in deflection of the third axis “A.sub.3-A.sub.3” by at least a predetermined angle (e.g., relative to the second axis “A.sub.2-A.sub.2”), the resultant movement of the second connector portion 33 results in activation of the switch “S”.

(30) Hereinafter, methods of manufacturing a clip-over disposable assembly in accordance with the present disclosure are described with reference to FIGS. 5 and 6. It is to be understood that the steps of the methods provided herein may be performed in combination and in a different order than presented herein without departing from the scope of the disclosure.

(31) FIG. 5 is a flowchart illustrating a method of manufacturing a clip-over disposable assembly 50 according to an embodiment of the present disclosure. In step 510, a switch assembly 100 is provided. Switch assembly 100 includes a user-actuatable button “B” including two user-accessible contact areas 4a and 4b.

(32) In step 520, first and second disposable members 57, 58 are provided. The first and second disposable members 57, 58 are configured to form an internal chamber 76, 78 when coupled together. The chamber 76, 78 is configured to accommodate at least a portion 46, 48 of the switch assembly 100 therein. The first and second disposable members 57, 58 may be formed in whole or in part of any suitable electrically non-conductive material, e.g., a suitable polymeric or ceramic material.

(33) In step 530, the second disposable member 58 is coupled to the first disposable member 57, wherein a first portion 4b of the user-actuatable button “B” is disposed in association with an outer peripheral surface of the first disposable member 57 and a second portion 4a of the user-actuatable button “B” is disposed in association with an outer peripheral surface the second disposable member 58. Any suitable joining method, e.g., ultrasonic welding, may be used to couple the second disposable member 58 to the first disposable member 57.

(34) In step 540, a third disposable member 59 is provided. Third disposable member 59 includes a wall portion 55 configured to form a chamber “C” when the first and third disposable members 57, 59 are coupled together. The chamber “C” is configured to receive therein at least a portion of a shaft 14 of a hemostat-style surgical instrument 20.

(35) In step 550, the third disposable member 59 is coupled to the first disposable member 57. In some embodiments, one or more conductors (e.g., three conductors 61a, 61b, 61c) suitable for transmitting electrosurgical energy through respective feed paths to end effectors 22 and 24 of an instrument 20 and/or electrical signals to control delivery of electrosurgical energy and/or feedback signals to control a source of electrosurgical energy 28 are over-molded prior to coupling the third disposable member 59 to the first disposable member 57, in step 550.

(36) FIG. 6 is a flowchart illustrating a method of manufacturing a clip-over disposable assembly 50 according to an embodiment of the present disclosure. In step 610, a switch assembly 100 is provided.

(37) Switch assembly 100 includes a user-actuatable button “B” including first and second user-accessible contact areas 4a and 4b. In some embodiments, the switch assembly 100 also includes a post member 30 including a post body 32, wherein the post body 32 defines a longitudinal axis “A.sub.3-A.sub.3” transverse to the longitudinal axis “A.sub.1-A.sub.1” of the connector member 30. In some embodiments, the post body 32 bisects or otherwise divides the connector member 30 into a first connector portion 31 and a second connector portion 33.

(38) In step 620, a first disposable member 57 is provided. First disposable member 57 includes first and second wall portions 51 and 52, respectively. The first wall portion 51 defines a first aperture 71 therethrough and a first cavity 76 associated with the first aperture 71. The first cavity 76 is configured to receive therein a first portion 46 of the switch assembly 100.

(39) In step 630, a second disposable member 58 is provided. Second disposable member 58 includes a body 54 defining a second aperture 74 therethrough and a second cavity 78 associated with the second aperture 74. The second cavity 78 is configured to receive therein a second portion 48 of the switch assembly 100.

(40) In step 640, the first portion 46 of the switch assembly 100 is positioned into the first cavity 76. The first user-accessible contact area 4b may be disposed in association with the first aperture 71.

(41) In step 650, a second portion 48 of the switch assembly 100 is positioned into the second cavity 78. The second user-accessible contact area 4b may be disposed in association with the second aperture 74.

(42) In step 660, the second disposable member 58 is coupled to the first disposable member 57. Any suitable joining method, e.g., ultrasonic welding, may be used to couple the second disposable member 58 to the first disposable member 57.

(43) In step 670, a third disposable member 59 is provided. Third disposable member 59 includes a third wall portion 55.

(44) In step 680, the third disposable member 59 is coupled to the first disposable member 57, wherein the third wall portion 55 and the second wall portion 52 cooperatively define a chamber “C” configured to receive therein at least a portion of a shaft 14 of a hemostat-style surgical instrument 20.

(45) The above-described clip-over disposable assembly embodiments including a switch assembly and a disposable body configured for side-mounting onto a hemostat-style surgical instrument are suitable for use with various types of hemostat-style surgical instruments, such as without limitation, electrosurgical forceps, and may be suitable for a variety of uses and applications. Embodiments may be used in conjunction with electrosurgical devices suitable for use with open and/or laparoscopic surgical procedures.

(46) The above-described methods of manufacturing a clip-over disposable assembly may be used in conjunction with a variety of electrosurgical devices adapted for treating tissue, such as bipolar electrosurgical forceps, monopolar electrosurgical forceps, and other hemostat-style surgical instruments. The above-described methods designed for ease of assembly a clip-over disposable assembly including a switch assembly and a disposable body configured for side-mounting onto a hemostat-style surgical instrument are suitable for use with a variety of types of hemostat-style surgical instruments.

(47) Although embodiments have been described in detail with reference to the accompanying drawings for the purpose of illustration and description, it is to be understood that the inventive processes and apparatus are not to be construed as limited thereby. It will be apparent to those of ordinary skill in the art that various modifications to the foregoing embodiments may be made without departing from the scope of the disclosure.