WO2007091074A2 - Method of manufacturing electrically powered surgical instruments, and electrically powered surgical instruments manufactured thereby - Google Patents

Method of manufacturing electrically powered surgical instruments, and electrically powered surgical instruments manufactured thereby Download PDF

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Publication number
WO2007091074A2
WO2007091074A2 PCT/GB2007/000442 GB2007000442W WO2007091074A2 WO 2007091074 A2 WO2007091074 A2 WO 2007091074A2 GB 2007000442 W GB2007000442 W GB 2007000442W WO 2007091074 A2 WO2007091074 A2 WO 2007091074A2
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WO
WIPO (PCT)
Prior art keywords
surgical
surgical instrument
connector device
housing
power
Prior art date
Application number
PCT/GB2007/000442
Other languages
French (fr)
Other versions
WO2007091074A3 (en
Inventor
Andre Sainsbury
Original Assignee
Powermed Systems Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Powermed Systems Ltd. filed Critical Powermed Systems Ltd.
Priority to GB0816249A priority Critical patent/GB2461106A/en
Publication of WO2007091074A2 publication Critical patent/WO2007091074A2/en
Publication of WO2007091074A3 publication Critical patent/WO2007091074A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1613Component parts
    • A61B17/1622Drill handpieces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064Constructional details of the endoscope body
    • A61B1/00105Constructional details of the endoscope body characterised by modular construction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064Constructional details of the endoscope body
    • A61B1/0011Manufacturing of endoscope parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1613Component parts
    • A61B17/1622Drill handpieces
    • A61B17/1624Drive mechanisms therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing

Definitions

  • the present invention relates to the manufacture of electrically powered surgical instruments.
  • surgical used herein includes both human and veterinary surgery.
  • Electrically powered surgical instruments are generally used to cut or drill through bone and other tissue, to enlarge or finish drilled holes, to affix screws, and for other surgical tasks.
  • Known electrically powered surgical instruments generally comprise a power tool portion and an instrument element portion connected to the power tool portion and controllably driven by it.
  • the instrument element is disposed generally externally of the housing of the tool portion.
  • the power may be supplied by batteries or mains, via suitable power source or supply devices connected to the tool. Control devices are provided, whereby the surgeon can control the instrument.
  • a range of instruments of different sizes, functionalities and strengths is required for a range of surgical tasks.
  • different instruments may need to be manufactured to cater for different surgical procedures.
  • different functionalities demand the manufacture of different instruments.
  • a method of manufacturing a range of electrically powered surgical instruments of different functionalities on a production scale comprising a surgical instrument element portion associated with, and driven in use by, a power tool portion, the method comprising, in any suitable order:
  • a movable connector device adapted to be connected with a surgical instrument element exteriorly of the housing
  • linkage means adapted to be disposed interiorly of the housing between the motor and the connector device for enabling the motor to drive the connector device and the connected surgical instrument element in the appropriate one of rotary, oscillating and reciprocating functionalities
  • the connector device is preferably adapted to be non-releasably connected to the surgical instrument element and in the said assembly process the surgical instrument element is preferably non- releasably connected to the connector device of the tool.
  • the assembly procedure is preferably fully performed on a production scale in the factory environment.
  • the connector device is preferably adapted to be releasably connected to the surgical instrument element and in the said assembly process the surgical instrument element is preferably releasably connected to the connector device of the tool.
  • the assembly procedure may be fully performed on a production scale in the factory environment, or may be performed on a production scale in the factory environment to the extent of providing the tools and the instrument elements separately, which are then releasably connected together on a single-instrument scale in each operating theatre environment to which the products of the factory have been supplied.
  • the means for transmitting power to the motor may comprise standard electrical contacts and circuitry which can cooperate with a battery pack or mains adaptor pack having corresponding electrical contacts to transmit electrical power to the motor via the said electrical contacts and circuitry.
  • the battery pack or mains adaptor pack is preferably separable from the tool.
  • the battery pack or mains adaptor pack is preferably disposed in use within or adjacent the housing.
  • the tools manufactured in one production run can have parts (c) which are also identical across the full range of instruments.
  • the adaptation of the resultant tools to battery or mains power source is achieved by selection of a battery pack or a mains adaptor pack to connect with the power transmitting means of the tool.
  • any or all of parts (d), (e) and (f) may also be the same for each tool and suitable for use with all of the surgical instrument elements.
  • instruments of different functionalities may be manufactured simultaneously in one production run, in which case mutually different parts (d) and/or (e) and/or (f) may be used in the same run.
  • the movable connector device part of the power tool may be releasably or non-releasably connected with the surgical instrument element of the set in part (ii) of the method.
  • a surgical power tool portion for use in an electrically powered surgical instrument, the power tool portion comprising:
  • the means for transmitting power to the motor comprise electrical contacts and circuitry which can cooperate with a battery pack or mains adaptor pack having corresponding electrical contacts to transmit electrical power to the power transmitting means (c), whereby the tool is adaptable to run from battery or mains power source by appropriate selection of a battery pack or a mains adaptor pack to connect with the power transmitting means (c) of the surgical power tool.
  • the battery pack or mains adaptor pack is preferably separable from the tool.
  • the battery pack or mains adaptor pack is preferably disposed in use within or adjacent the housing.
  • the configuration of those portions of the battery pack and the mains adaptor pack that fit to the power tool are generally similar to each other.
  • the power tool portion preferably further comprises:
  • linkage means disposed interiorly of the housing between the motor and the connector device for enabling the motor to drive the connector device and the connected surgical instrument element in the appropriate one of rotary, oscillating and reciprocating functionalities
  • (f) means which in use control the connector device to enable a surgical instrument element connected thereto to perform its surgical utility.
  • the surgical instrument using the power tool portion according to the third aspect of the present invention may if desired be an instrument according to the second aspect of the invention.
  • the instruments manufactured by the method of the present invention will generally retain the same functional and control characteristics as prior art electrically powered surgical instruments, so that the surgeon will notice no essential difference between instruments manufactured by the method of the invention and instruments manufactured by any prior art method. Therefore, the details of the instruments made according to the present invention, including their functionalities and control systems, do not need to be described laboriously in this application, as they are readily available to those skilled in the art on the basis of prior art and common knowledge. Detailed Description of the Invention
  • production scale refers to a manufacturing scale large enough, fast enough and continuous enough that the supply of sufficient parts to maintain the process can present logistical difficulties of sourcing, transportation and storage.
  • the production scale at which the method of the present invention may operate can be at least about 20 units per hour, for example at least about 40 units per hour, for example at least about 60 units per hour.
  • the production time scale is preferably continuous to the extent at least of the normal working week (e.g. at least about 35 hours per week in five seven-hour production periods), up to full continuity of 168 hours per week, and all intermediate degrees of continuity.
  • the production scale will represent at least one production run of the manufacturing facility to manufacture a large number of surgical instruments, for example at least several hundred units, for example at least about 1000 units, preferably at least about 2000 units.
  • the surgical instrument elements provided in the manufacturing method of the present invention suitably comprise a full range of rotary, oscillating and reciprocating surgical instrument elements that a surgeon will require for the surgical procedures that he carries out in his work, or the surgeons who work in the location in question (e.g. the particular operating theatre where the kit is located) will require.
  • the instrument elements comprise only rotary, or only oscillating, or only reciprocating instrument elements, or only two of these types of instrument elements, if a limited production run is being undertaken.
  • Each surgical instrument element for use in the present invention comprises a functional portion and a connective portion.
  • the functional portion is specifically adapted for the intended purpose.
  • the functional portion of a surgical instrument element for use in a particular surgical procedure or group of surgical procedures will have a suitable configuration and size, and be made of suitable materials, for that procedure or group of procedures.
  • a conventional configuration and size, and conventional materials will be used.
  • the functional portion of a rotary instrument element for use in the present invention may have the conventional configuration of a surgical drill, reamer or screwdriver.
  • the drill, reamer or screwdriver will have the size appropriate to the intended surgical procedure or group of procedures in which it will be used, and will be constructed from a material appropriate to the intended surgical procedure or group of procedures in which it will be used, bearing in mind, for example, the strength and other requirements of the material.
  • an oscillating instrument element for use in the present invention may have the conventional configuration of a surgical oscillating saw.
  • the saw will have the size appropriate to the intended surgical procedure or group of procedures in which it will be used, and will be constructed from a material appropriate to the intended surgical procedure or group of procedures in which it will be used, bearing in mind, for example, the strength and other requirements of the material.
  • the functional portion of a reciprocating instrument element for use in the present invention may have the conventional configuration of a surgical reciprocating saw.
  • the saw will have the size appropriate to the intended surgical procedure or group of procedures in which it will be used, and will be constructed from a material appropriate to the intended surgical procedure or group of procedures in which it will be used, bearing in mind, for example, the strength and other requirements of the material.
  • the connective portion is adapted to enable the surgical instrument element to be securely connected for use to the connector device of the power tool.
  • the connective portion of the surgical instrument assembly and the connector device of the power tool suitably comprise cooperating portions which provide for said secure connection.
  • the cooperating portions will be selected from suitable known mechanical connecting and fastening systems, as will be well within the capacity of those skilled in the art.
  • conventional connecting and fastening systems known in prior surgical power tool assemblies will be used. Non-limiting examples of such systems include push-fit systems, snap-fit systems, bayonet-fit systems, nut- and-bolt systems, key-operable chuck systems, keyless chuck systems, screw-fit systems, bolt-on systems, pin systems, and any suitable combination thereof.
  • the connection between the surgical instrument element and the power tool may be releasable or non-releasable.
  • the functional and connective portions of the surgical instrument element are preferably integral with each other.
  • the surgical instrument element is preferably formed in metal or strong plastic, according to the known or conventional practice for surgical instruments of the type in question. Any suitable manufacturing techniques may be used, as will be well within the capacity of those skilled in the art. Examples of suitable manufacturing techniques include casting, extruding, moulding, machining, etching, pressure-forming, bending, hammering, cutting, and any suitable combination thereof.
  • each of the electrically powered surgical instruments manufactured according to the present invention is novel in the context of the production scale method because, in contrast to the prior art, at least the housing and optionally also the motor and/or other parts are the same in all the power tool portions of a production scale range of surgical instruments.
  • Each assembled power tool portion comprises at least a housing having an associated handle part, an electric motor disposed within the housing, means which in use transmit electrical power to the motor, a movable connector device adapted to be connected with a surgical instrument element exteriorly of the housing, linkage' means disposed interiorly of the housing between the motor and the connector device for enabling the motor to drive the connector device and the connected surgical instrument element in the appropriate one of rotary, oscillating and reciprocating functionalities, and means which in use control the connector device to enable a surgical instrument element connected thereto to perform its surgical utility.
  • the housing is suitably constructed of a moulded plastics material in conventional manner, as will be readily understood by those skilled in the art.
  • the housing may conveniently be provided in two or more pieces which are secured together in conventional manner during the manufacturing process.
  • the handle part will typically be provided as a suitably configured portion of the housing. It is preferred that the housing is in a generally pistol configuration, the handle being a pistol-grip handle with control devices provided in locations convenient for the fingers of the surgeon holding the instrument, e.g. in the trigger location.
  • the housing may be provided with a secondary stabilising handle, in addition to the primary (e.g. pistol- grip) handle, whereby the surgeon can steady the instrument in use, using his secondary hand, while operating the instrument with his dominant or primary hand.
  • a secondary stabilising handle may be detachably or permanently mounted to the exterior of the housing.
  • the electric motor may be selected from any electric motor capable of developing sufficient torque for the intended use of the instrument. Such motors are commercially available.
  • the means which in use provide electrical power to the motor may suitably be selected from batteries for a battery-powered instrument and a mains power cable for a mains-powered instrument. Such parts are commercially available.
  • a chamber for receiving the battery or batteries may be provided in the housing of a battery-powered tool, and in the case of a mains-powered tool a power cable may be provided which connects the electrical motor to a mains power source.
  • Suitable electrical connections and circuitry will be provided in conventional manner, to enable the electrical power to be controlled and supplied to the motor as desired, and to enable any batteries to be recharged and/or replaced as desired.
  • the configuration of those portions of the battery pack and the mains adaptor pack that fit to the power tool are generally similar to each other.
  • the movable connector device preferably takes the form of a coupling, e.g. of metal or plastics, movably mounted in an aperture of the housing.
  • the connector device In the assembled instrument the connector device is connected, interiorly of the housing, to the motor via the linkage means and connected, exteriorly of the housing, to the instrument element.
  • the nature and location of the connector device will be dictated by the functionality of the instrument.
  • the connector device will suitably be located at the end of the barrel portion of the housing, and arranged so that any associated instrument element extends from the barrel portion away from the handle and can rotate in use about its long axis.
  • the connector device will suitably be located at the end of the barrel portion of the housing, and arranged so that any associated instrument element extends from the barrel portion away from the handle and can reciprocate in use along its long axis.
  • the connector device will suitably be located at the end of the barrel portion of the housing, and arranged so that any associated instrument element extends from the barrel portion away from the handle and can oscillate in use about a pivot arranged orthogonal to the direction of the instrument element.
  • the standard housing part (a) has two or more pre-formed apertures, facing in different directions from one another, for receiving a connector device in such a way as to present it in the appropriate orientation for connection of the instrument element, according to the desired orientation and functionality of the instrument element.
  • the linkage means suitably comprise conventional mechanical linkage systems for transmitting rotary motion of an electric motor to rotary motion, reciprocation motion or osculating motion of a connector device.
  • the means which in use control the connector device to enable a surgical instrument element connected thereto to perform its surgical utility suitably comprise one or more finger-operable instrument control devices (typically selected from buttons, levers, touch pads, touch panels, push pads or any combination thereof) and may be provided in proximity to the handle part, whereby the surgeon can control the instrument.
  • the control may be achieved by any conventional means for controlling the speed and/or direction of electric motors, for example, pulse width modulation and forward/reverse switching.
  • one or more surgeon-pedal-operable or assistant-operable external control devices may be used in place of or additional to finger-operable instrument control devices.
  • the mechanical linkages and control devices typically include one or more of gears, mechanisms for transferring rotary motion of the motor to reciprocating motion, mechanisms for transferring rotary motion of the motor to oscillating motion, electrical switches, variable electrical current controllers, brakes, etc.
  • the mechanical linkages may be constructed in metal, plastics, any combination thereof, or any other suitable material.
  • the mechanical linkages may suitably be provided as modules including coaxial gear trains.
  • the various arangements are all of an overall size capable of fitting within the standardised housing (a).
  • the gearing permits forward and reverse driving of the connector device, for example under the surgeon's control and as an inherent part of the functionality (e.g. in the reciprocating and oscillating functionalities).
  • the gearing system provides for co- and contra- rotation and/or for combined rotational/linear movement.
  • the coaxial gears transmit the rotary motion of the motor to rotary motion of a shaft which drives the connector device, to provide for rotary functionality of the instrument.
  • the gears include worms or other engaging thread systems in conventional manner, which provide for reciprocating to-and-fro motion of a shaft which drives the connector device, to provide for reciprocating functionality of the instrument.
  • the gears include cams and/or joints (e.g. geared or universal joints) in conventional manner, which provide for oscillating to-and-fro motion of a pinion which drives the connector device, the axis of the pinion being optionally orientated differently from the axis of the shaft in the alternative embodiments just described, to provide for oscillating functionality of the instrument
  • the orientation of the shafts or pinions may, if desired, be variable so that the surgeon can set the orientation before use of the instrument. Assembly of the Instruments
  • the parts of the power tools and the instrument elements are assembled, to provide the surgical power instruments each comprising a tool and an instrument element.
  • the power tool can then be operated after a suitable battery pack or mains adaptor has been connected.
  • the parts and the instrument elements other than the housing may be assemble and the housing fitted last.
  • a power tool may be assembled to completion of that part and the instrument element subsequently fitted in the factory.
  • a power tool may be assembled to completion of that part in the factory and the instrument element subsequently fitted in the operating theatre.
  • a rotary-to-rotary mechanical linkage system with a certain gearing ratio or range of gearing ratios may be provided in a modular form for fitting into the housing when manufacturing an instrument having rotary functionality requiring that gearing ratio or range of gearing ratios.
  • a rotary-to-reciprocating mechanical linkage system with a certain gearing ratio or range of gearing ratios may be provided in a modular form for slotting into the housing when manufacturing an instrument having reciprocating functionality requiring that gearing ratio or range of gearing ratios, etc.
  • Figure 1 illustrates the power tool part (omitting the instrument element) of a battery-operated electrically powered surgical instrument
  • Figure 2 illustrates (a) from the side and (b) from below the battery pack present in the tool part of Figure 1;
  • Figure 3 illustrates an adaptor pack and accessories for converting the tool part of Figure 1 to be mains-powered
  • Figure 4 illustrates alternative mechanical linkage systems that can be used within the tool part of Figure 1, namely (a) top view of rotary-to-rotary (i) with a top view outline of the housing superimposed and (ii) without the top view of the housing, (b) side view of the system of (a), (c) side view of rotary-to-reciprocating, and (d) side view of rotary-to-oscillating, with, for comparison, the side silhouette of part of the housing being illustrated to the same scale in (e).
  • the tool comprises the following parts: a housing 1 in pistol-grip configuration having an associated handle part 2; an electric motor 3 disposed within the housing; a battery pack 4 having a connector portion 4a receivable in a chamber within the handle part 2 of the housing 1, which in use provides electrical power to the motor 3; a movable connector device 5a or 5b adapted to be connected with a surgical instrument element (not shown) exteriorly of the housing; linkage means 6 disposed interiorly of the housing 1 between the motor 2 and the connector device 5a,5b for enabling the motor to drive the connector device and the connected surgical instrument element in the appropriate one of rotary, oscillating and reciprocating functionalities; and a finger-operable control device 7 which in use enables the surgeon to control the speed, and optionally also the direction of movement, of the connector device 5a,5b to enable the surgical instrument element connected thereto to perform its surgical utility.
  • the control device 7 may, for example, include a forward/reverse switching function and may control the speed of the motor 3 via a pulse width
  • both forms of movable connector device 5a, 5b are illustrated, each fully operational via a multifunctional system of linkages 6.
  • the connector device 5 a is directed orthogonally to the connector device 5b.
  • the housing 1 is provided with two apertures for receiving the two connector devices.
  • the linkage systems shown in Figure 4 are simpler, in that only one connector device 5a is employed, and only one functionality is provided for it through the linkage system 6.
  • the linkages shown in Figure 4 are thus partial versions of the multifunctional linkage system of Figure 1.
  • one of the two apertures of the housing will be redundant, and will be sealed off by a separate or integral sealing cover.
  • the sealing cover is integral with the remainder of the housing, this may be provided by initially providing the housing with both apertures sealed off by frangible webs (e.g. of plastics), one of which can be removed to prepare the housing part for use.
  • the linkage system 6 may be provided in modular form for fitting into the housing 1, and the linkage system 6 may be pre-connected to motor 3 to provide a linkage/motor module for fitting into the housing 1.
  • the linkage system 6 illustrated in Figure 4(a) and (b) is a rotary-to- rotary linkage suitable for use in a drill, reamer or screwdriver;
  • the linkage system 6 illustrated in Figure 4(c) is a rotary-to-reciprocating linkage suitable for use in a reciprocating saw;
  • the linkage system 6 illustrated in Figure 4(d) is a rotary-to- oscillating linkage suitable for use in an oscillating saw.
  • the tool may alternatively or additionally include features (not shown) including, for example, any one or more of: a membrane switch panel (e.g. of polyester or silicone) (not shown), on the surface of the housing providing multiple function control by finger operation by the surgeon, LEDs or other visual display devices showing the powered/unpowered status indication of the instrument or its functions, the display devices being optionally provided in the membrane switch panel, and/or a separate on/off switch panel.
  • a membrane switch panel e.g. of polyester or silicone
  • LEDs or other visual display devices showing the powered/unpowered status indication of the instrument or its functions
  • the display devices being optionally provided in the membrane switch panel, and/or a separate on/off switch panel.
  • the tool may be converted from battery power to mains power by means of an adaptor pack 8 which is configured to engage in the battery chamber of the handle part 2 of the housing 1 and to establish appropriate electrical connections to the motor 3, analagously to the battery-powered tool.
  • the adaptor pack is connectable to a mains power supply 9 via a conventional cable 10.
  • the electrical parts are controlled by means of conventional circuitry mounted on a printed circuit board (not shown).
  • circuitry will suitably include transformers, converters and regulators in conventional manner, whereby the tool is functional for battery power or for mains power in more than one main voltage as conventionally used internationally, and the risk of possibly lethal electric shocks from faults or failures is reduced. It is preferred that all international mains voltages are catered for.
  • the circuitry may includes more than one - e.g. three - mutually independent power converters, to reduce the risk of failure of power output during a surgical procedure.
  • An input converter may preferably incorporate an active power factor correction unit using average mode control on the incoming mains, together with a suitable controller, to compensate for possible current surges or fluctuations.
  • An output converter may preferably incorporate a synchronous current mode switching regulator and a suitable controller.
  • the intermediate converter between the input and output converters may preferably be or include a phase shift full bridge converter and a suitable controller.
  • the circuitry further incorporates a device providing for pulse width modulation for control of the output speed of the motor 3, in conventional manner, under the control of the surgeon via the fmger-operatable control device 7.
  • the power tools illustrated provide the basis for a wide range of single-use and repeat-use surgical instruments, as has already been described, hi the case of a single-use instrument, the battery pack 2 (or adaptor 8) and optionally also the instrument element used will be disconnected from the remainder of the tool after use, and the tool discarded or recycled. In the case of a repeat-use instrument, the battery pack 2 (or adaptor 8) and the instrument element used will be disconnected from the remainder of the tool after use and all the parts will be cleaned and sterilised for reuse.
  • the parts are preferably provided in modular form, whereby the tool can easily be assembled in mass production according to the method of the present invention described above.
  • At least the housing 1, and optionally also any one or more of the motor 3, the power supply unit 4, the mechanical linkage system 6, the mains adaptor 8 and the circuitry and accessories are standard for a range of instruments, which provides considerable logistical and economic advantages to the production scale manufacture.
  • the connector device 5a,5b is preferably adapted to be non-releasably connected to the surgical instrument element as described generally above, and in the said assembly process the surgical instrument element is preferably non-releasably connected to the connector device 5a, 5b of the tool.
  • the assembly procedure is preferably fully performed on a production scale in the factory environment.
  • the connector device 5 a, 5b is preferably adapted to be releasably connected to the surgical instrument element as described generally above, and in the said assembly process the surgical instrument element is preferably releasably connected to the connector device 5a,5b of the tool.
  • the assembly procedure may be fully performed on a production scale in the factory environment, or may be performed on a production scale in the factory environment to the extent of providing the tools and the instrument elements separately, which are then releasably connected together on a single-instrument scale in each operating theatre environment to which the products of the factory have been supplied.
  • the present invention provides substantial advantages in the manufacture of electrically powered surgical instruments.
  • the preferred use of modular parts of the power tools for example the mechanical linkage systems, the power sources and/or motor enables a wide range of instruments, both single-use and repeat-use, to be manufactured easily and economically, based on the standard basic combination of housing, motor and power supply means.

Abstract

A novel method of manufacturing single-use or repeat-use electrically powered surgical instruments comprises assembling the instruments on a production scale in a range of functionalities. Electrically powered surgical instruments manufactured using the novel method are also described.

Description

METHOD OF MANUFACTURING ELECTRICALLY POWERED SURGICAL INSTRUMENTS, AND ELECTRICALLY POWERED
SURGICAL INSTRUMENTS MANUFACTURED THEREBY
Field of the Invention
The present invention relates to the manufacture of electrically powered surgical instruments. The term "surgical" used herein includes both human and veterinary surgery.
Background of the Invention
Electrically powered surgical instruments are generally used to cut or drill through bone and other tissue, to enlarge or finish drilled holes, to affix screws, and for other surgical tasks.
Known electrically powered surgical instruments generally comprise a power tool portion and an instrument element portion connected to the power tool portion and controllably driven by it. The instrument element is disposed generally externally of the housing of the tool portion. The power may be supplied by batteries or mains, via suitable power source or supply devices connected to the tool. Control devices are provided, whereby the surgeon can control the instrument.
A range of instruments of different sizes, functionalities and strengths is required for a range of surgical tasks. Thus, for example, even within one particular category of functionality (rotary, reciprocating or oscillating), different instruments may need to be manufactured to cater for different surgical procedures. In addition, different functionalities demand the manufacture of different instruments.
For this reason, the manufacture of a set of electrically powered surgical instruments as required by a typical operating theatre has in the past been a complex operation in which to a large extent the parts are unique to a particular instrument. It has not hitherto been possible to mass-manufacture a range of such instruments using standardised housing and optionally other parts. Where - as is common - the surgeon demands single-use instruments (to avoid a risk of cross-contamination of patients), this complexity of manufacture increases the costs of instruments that will only be used for a few hours and then must be discarded or dismantled, and is environmentally unsatisfactory in terms of consumption of materials and energy. The inflexibility of the manufacturing known processes has impeded the introduction of more environmentally friendly repeat-use instruments, which introduce their own difficulties in terms of effective cleaning and sterilisation between operations, and which usually require at least partial dismantling and reassembling.
It is an object of the present invention to provide a, improved or at least alternative method of manufacturing a range of electrically powered surgical instruments of different functionalities on a production scale.
Brief Description of the Invention
According to a first aspect of the present invention, there is provided a method of manufacturing a range of electrically powered surgical instruments of different functionalities on a production scale, the surgical instruments comprising a surgical instrument element portion associated with, and driven in use by, a power tool portion, the method comprising, in any suitable order:
(i) providing on a production scale a plurality of surgical instrument elements having functionality types selected from two or three, preferably all three, of: rotary-type, oscillating-type and reciprocating-type surgical instrument elements, each of the surgical instrument elements being adapted to be connected to a surgical power tool to provide an electrically powered surgical instrument; (ii) providing on a production scale parts for constructing a plurality of surgical power tools for all the said surgical instrument elements, each tool comprising the following parts:
(a) a housing having an associated handle part,
(b) an electric motor adapted to be disposed within the housing,
(c) means which in use transmit electrical power to the motor,
(d) a movable connector device adapted to be connected with a surgical instrument element exteriorly of the housing, (e) linkage means adapted to be disposed interiorly of the housing between the motor and the connector device for enabling the motor to drive the connector device and the connected surgical instrument element in the appropriate one of rotary, oscillating and reciprocating functionalities, and (f) means which in use control the connector device to enable a surgical instrument element connected thereto to perform its surgical utility,
at least the part (a) being the same for each tool and suitable for use with all of the said surgical instrument elements;
(iii) in any suitable order, assembling the parts and connecting an appropriate surgical instrument element to the connector device, to provide on a production scale either the plurality of surgical power instruments each comprising a tool and an instrument element, or a plurality of tools and instrument elements from which the surgical instruments can be assembled.
It is preferred that at least parts (a) and (b) are the same for each tool and suitable for use with all of the said surgical instrument elements provided in (i) for use in the production method. Where single-use instruments are desired, the connector device is preferably adapted to be non-releasably connected to the surgical instrument element and in the said assembly process the surgical instrument element is preferably non- releasably connected to the connector device of the tool. The assembly procedure is preferably fully performed on a production scale in the factory environment.
Where repeat-use instruments are desired, the connector device is preferably adapted to be releasably connected to the surgical instrument element and in the said assembly process the surgical instrument element is preferably releasably connected to the connector device of the tool. The assembly procedure may be fully performed on a production scale in the factory environment, or may be performed on a production scale in the factory environment to the extent of providing the tools and the instrument elements separately, which are then releasably connected together on a single-instrument scale in each operating theatre environment to which the products of the factory have been supplied.
According to a second aspect of the present invention, there are provided single-use or repeat-use electrically powered surgical instruments manufactured using the above method.
The means for transmitting power to the motor may comprise standard electrical contacts and circuitry which can cooperate with a battery pack or mains adaptor pack having corresponding electrical contacts to transmit electrical power to the motor via the said electrical contacts and circuitry. The battery pack or mains adaptor pack is preferably separable from the tool. The battery pack or mains adaptor pack is preferably disposed in use within or adjacent the housing. Thus, the tools manufactured in one production run can have parts (c) which are also identical across the full range of instruments. The adaptation of the resultant tools to battery or mains power source is achieved by selection of a battery pack or a mains adaptor pack to connect with the power transmitting means of the tool. If desired, to the extent that only one of the three functionalities is enabled in any one production run, any or all of parts (d), (e) and (f) may also be the same for each tool and suitable for use with all of the surgical instrument elements. However, if desired, instruments of different functionalities may be manufactured simultaneously in one production run, in which case mutually different parts (d) and/or (e) and/or (f) may be used in the same run.
In use, the movable connector device part of the power tool may be releasably or non-releasably connected with the surgical instrument element of the set in part (ii) of the method.
According to a third aspect of the present invention, there is provided a surgical power tool portion for use in an electrically powered surgical instrument, the power tool portion comprising:
(a) a housing having an associated handle part,
(b) an electric motor disposed within the housing, and
(c) means which in use transmit electrical power to the motor,
wherein the means for transmitting power to the motor comprise electrical contacts and circuitry which can cooperate with a battery pack or mains adaptor pack having corresponding electrical contacts to transmit electrical power to the power transmitting means (c), whereby the tool is adaptable to run from battery or mains power source by appropriate selection of a battery pack or a mains adaptor pack to connect with the power transmitting means (c) of the surgical power tool.
The battery pack or mains adaptor pack is preferably separable from the tool. The battery pack or mains adaptor pack is preferably disposed in use within or adjacent the housing. To provide the necessary adaptability of the tool to battery or mains power, the configuration of those portions of the battery pack and the mains adaptor pack that fit to the power tool are generally similar to each other. In the electrically powered surgical instrument using the power tool portion according to the third aspect of the present invention, the power tool portion preferably further comprises:
(d) a movable connector device adapted to be connected with the surgical instrument element exteriorly of the housing,
(e) linkage means disposed interiorly of the housing between the motor and the connector device for enabling the motor to drive the connector device and the connected surgical instrument element in the appropriate one of rotary, oscillating and reciprocating functionalities, and
(f) means which in use control the connector device to enable a surgical instrument element connected thereto to perform its surgical utility.
The surgical instrument using the power tool portion according to the third aspect of the present invention may if desired be an instrument according to the second aspect of the invention.
The instruments manufactured by the method of the present invention will generally retain the same functional and control characteristics as prior art electrically powered surgical instruments, so that the surgeon will notice no essential difference between instruments manufactured by the method of the invention and instruments manufactured by any prior art method. Therefore, the details of the instruments made according to the present invention, including their functionalities and control systems, do not need to be described laboriously in this application, as they are readily available to those skilled in the art on the basis of prior art and common knowledge. Detailed Description of the Invention
The Production Scale
The term "production scale" used herein refers to a manufacturing scale large enough, fast enough and continuous enough that the supply of sufficient parts to maintain the process can present logistical difficulties of sourcing, transportation and storage.
For example, the production scale at which the method of the present invention may operate can be at least about 20 units per hour, for example at least about 40 units per hour, for example at least about 60 units per hour. The production time scale is preferably continuous to the extent at least of the normal working week (e.g. at least about 35 hours per week in five seven-hour production periods), up to full continuity of 168 hours per week, and all intermediate degrees of continuity. There is no upper limit on the production volume at which the present invention may be operated, the constraints being essentially the size of the manufacturing facility and the workforce.
Preferably, the production scale will represent at least one production run of the manufacturing facility to manufacture a large number of surgical instruments, for example at least several hundred units, for example at least about 1000 units, preferably at least about 2000 units.
The Surgical Instrument Elements
The surgical instrument elements provided in the manufacturing method of the present invention suitably comprise a full range of rotary, oscillating and reciprocating surgical instrument elements that a surgeon will require for the surgical procedures that he carries out in his work, or the surgeons who work in the location in question (e.g. the particular operating theatre where the kit is located) will require.
However, in certain cases it may be that the instrument elements comprise only rotary, or only oscillating, or only reciprocating instrument elements, or only two of these types of instrument elements, if a limited production run is being undertaken.
Each surgical instrument element for use in the present invention comprises a functional portion and a connective portion.
The functional portion is specifically adapted for the intended purpose. Thus, the functional portion of a surgical instrument element for use in a particular surgical procedure or group of surgical procedures will have a suitable configuration and size, and be made of suitable materials, for that procedure or group of procedures. Preferably, a conventional configuration and size, and conventional materials, will be used.
Thus, for example, the functional portion of a rotary instrument element for use in the present invention may have the conventional configuration of a surgical drill, reamer or screwdriver. The drill, reamer or screwdriver will have the size appropriate to the intended surgical procedure or group of procedures in which it will be used, and will be constructed from a material appropriate to the intended surgical procedure or group of procedures in which it will be used, bearing in mind, for example, the strength and other requirements of the material.
Furthermore, for example, the functional portion of an oscillating instrument element for use in the present invention may have the conventional configuration of a surgical oscillating saw. The saw will have the size appropriate to the intended surgical procedure or group of procedures in which it will be used, and will be constructed from a material appropriate to the intended surgical procedure or group of procedures in which it will be used, bearing in mind, for example, the strength and other requirements of the material.
Still further, for example, the functional portion of a reciprocating instrument element for use in the present invention may have the conventional configuration of a surgical reciprocating saw. The saw will have the size appropriate to the intended surgical procedure or group of procedures in which it will be used, and will be constructed from a material appropriate to the intended surgical procedure or group of procedures in which it will be used, bearing in mind, for example, the strength and other requirements of the material.
The connective portion is adapted to enable the surgical instrument element to be securely connected for use to the connector device of the power tool. The connective portion of the surgical instrument assembly and the connector device of the power tool suitably comprise cooperating portions which provide for said secure connection. The cooperating portions will be selected from suitable known mechanical connecting and fastening systems, as will be well within the capacity of those skilled in the art. Preferably, conventional connecting and fastening systems known in prior surgical power tool assemblies will be used. Non-limiting examples of such systems include push-fit systems, snap-fit systems, bayonet-fit systems, nut- and-bolt systems, key-operable chuck systems, keyless chuck systems, screw-fit systems, bolt-on systems, pin systems, and any suitable combination thereof. The connection between the surgical instrument element and the power tool may be releasable or non-releasable.
The functional and connective portions of the surgical instrument element are preferably integral with each other. The surgical instrument element is preferably formed in metal or strong plastic, according to the known or conventional practice for surgical instruments of the type in question. Any suitable manufacturing techniques may be used, as will be well within the capacity of those skilled in the art. Examples of suitable manufacturing techniques include casting, extruding, moulding, machining, etching, pressure-forming, bending, hammering, cutting, and any suitable combination thereof.
Ηie Power Tools
The power tool portion of each of the electrically powered surgical instruments manufactured according to the present invention is novel in the context of the production scale method because, in contrast to the prior art, at least the housing and optionally also the motor and/or other parts are the same in all the power tool portions of a production scale range of surgical instruments.
Each assembled power tool portion comprises at least a housing having an associated handle part, an electric motor disposed within the housing, means which in use transmit electrical power to the motor, a movable connector device adapted to be connected with a surgical instrument element exteriorly of the housing, linkage' means disposed interiorly of the housing between the motor and the connector device for enabling the motor to drive the connector device and the connected surgical instrument element in the appropriate one of rotary, oscillating and reciprocating functionalities, and means which in use control the connector device to enable a surgical instrument element connected thereto to perform its surgical utility.
The housing is suitably constructed of a moulded plastics material in conventional manner, as will be readily understood by those skilled in the art. The housing may conveniently be provided in two or more pieces which are secured together in conventional manner during the manufacturing process. The handle part will typically be provided as a suitably configured portion of the housing. It is preferred that the housing is in a generally pistol configuration, the handle being a pistol-grip handle with control devices provided in locations convenient for the fingers of the surgeon holding the instrument, e.g. in the trigger location. The housing may be provided with a secondary stabilising handle, in addition to the primary (e.g. pistol- grip) handle, whereby the surgeon can steady the instrument in use, using his secondary hand, while operating the instrument with his dominant or primary hand. Such a secondary stabilising handle may be detachably or permanently mounted to the exterior of the housing.
The electric motor may be selected from any electric motor capable of developing sufficient torque for the intended use of the instrument. Such motors are commercially available.
The means which in use provide electrical power to the motor may suitably be selected from batteries for a battery-powered instrument and a mains power cable for a mains-powered instrument. Such parts are commercially available. A chamber for receiving the battery or batteries may be provided in the housing of a battery-powered tool, and in the case of a mains-powered tool a power cable may be provided which connects the electrical motor to a mains power source. Suitable electrical connections and circuitry will be provided in conventional manner, to enable the electrical power to be controlled and supplied to the motor as desired, and to enable any batteries to be recharged and/or replaced as desired. To provide adaptability of the tool to battery or mains power, the configuration of those portions of the battery pack and the mains adaptor pack that fit to the power tool are generally similar to each other.
The movable connector device preferably takes the form of a coupling, e.g. of metal or plastics, movably mounted in an aperture of the housing. In the assembled instrument the connector device is connected, interiorly of the housing, to the motor via the linkage means and connected, exteriorly of the housing, to the instrument element. The nature and location of the connector device will be dictated by the functionality of the instrument. Thus, for example, in an instrument having a pistol- grip housing and rotary functionality, the connector device will suitably be located at the end of the barrel portion of the housing, and arranged so that any associated instrument element extends from the barrel portion away from the handle and can rotate in use about its long axis. In an instrument having a pistol-grip housing and reciprocating functionality, the connector device will suitably be located at the end of the barrel portion of the housing, and arranged so that any associated instrument element extends from the barrel portion away from the handle and can reciprocate in use along its long axis. In an instrument having a pistol-grip housing and oscillating functionality, the connector device will suitably be located at the end of the barrel portion of the housing, and arranged so that any associated instrument element extends from the barrel portion away from the handle and can oscillate in use about a pivot arranged orthogonal to the direction of the instrument element.
It is thus preferred that the standard housing part (a) has two or more pre-formed apertures, facing in different directions from one another, for receiving a connector device in such a way as to present it in the appropriate orientation for connection of the instrument element, according to the desired orientation and functionality of the instrument element.
The linkage means suitably comprise conventional mechanical linkage systems for transmitting rotary motion of an electric motor to rotary motion, reciprocation motion or osculating motion of a connector device.
The means which in use control the connector device to enable a surgical instrument element connected thereto to perform its surgical utility suitably comprise one or more finger-operable instrument control devices (typically selected from buttons, levers, touch pads, touch panels, push pads or any combination thereof) and may be provided in proximity to the handle part, whereby the surgeon can control the instrument. The control may be achieved by any conventional means for controlling the speed and/or direction of electric motors, for example, pulse width modulation and forward/reverse switching. If desired, one or more surgeon-pedal-operable or assistant-operable external control devices may be used in place of or additional to finger-operable instrument control devices. The mechanical linkages and control devices typically include one or more of gears, mechanisms for transferring rotary motion of the motor to reciprocating motion, mechanisms for transferring rotary motion of the motor to oscillating motion, electrical switches, variable electrical current controllers, brakes, etc. The mechanical linkages may be constructed in metal, plastics, any combination thereof, or any other suitable material.
The mechanical linkages may suitably be provided as modules including coaxial gear trains. The various arangements are all of an overall size capable of fitting within the standardised housing (a). The gearing permits forward and reverse driving of the connector device, for example under the surgeon's control and as an inherent part of the functionality (e.g. in the reciprocating and oscillating functionalities). For example, the gearing system provides for co- and contra- rotation and/or for combined rotational/linear movement. In one arrangement, the coaxial gears transmit the rotary motion of the motor to rotary motion of a shaft which drives the connector device, to provide for rotary functionality of the instrument. In another arrangement, the gears include worms or other engaging thread systems in conventional manner, which provide for reciprocating to-and-fro motion of a shaft which drives the connector device, to provide for reciprocating functionality of the instrument. In another arrangement, the gears include cams and/or joints (e.g. geared or universal joints) in conventional manner, which provide for oscillating to-and-fro motion of a pinion which drives the connector device, the axis of the pinion being optionally orientated differently from the axis of the shaft in the alternative embodiments just described, to provide for oscillating functionality of the instrument The orientation of the shafts or pinions may, if desired, be variable so that the surgeon can set the orientation before use of the instrument. Assembly of the Instruments
According to the method of the present invention, in any suitable order the parts of the power tools and the instrument elements are assembled, to provide the surgical power instruments each comprising a tool and an instrument element. The power tool can then be operated after a suitable battery pack or mains adaptor has been connected.
For example, the parts and the instrument elements other than the housing may be assemble and the housing fitted last. Alternatively, a power tool may be assembled to completion of that part and the instrument element subsequently fitted in the factory. Alternatively, in the case of an instrument for which it is envisaged that the instrument element may be replaced or selected by the surgeon or surgical assistant, a power tool may be assembled to completion of that part in the factory and the instrument element subsequently fitted in the operating theatre.
To assist the assembly process, it is preferred that at least some of the parts are provided in modular form, and adapted to engage or fit easily with appropriate regions of the housing. Thus, for example, a rotary-to-rotary mechanical linkage system with a certain gearing ratio or range of gearing ratios may be provided in a modular form for fitting into the housing when manufacturing an instrument having rotary functionality requiring that gearing ratio or range of gearing ratios. In another example, a rotary-to-reciprocating mechanical linkage system with a certain gearing ratio or range of gearing ratios may be provided in a modular form for slotting into the housing when manufacturing an instrument having reciprocating functionality requiring that gearing ratio or range of gearing ratios, etc.
The details of the assembly and final adjustments of the instruments are conventional and are well understood by those skilled in the art, so that detailed description is not required here. Brief Description of the Drawings
For a better understanding of the present invention, and to show how the same may be performed, an embodiment will now be described, without limitation and purely for illustrative purposes, with reference to the accompanying drawings.
In the drawings:
Figure 1 illustrates the power tool part (omitting the instrument element) of a battery-operated electrically powered surgical instrument;
Figure 2 illustrates (a) from the side and (b) from below the battery pack present in the tool part of Figure 1;
Figure 3 illustrates an adaptor pack and accessories for converting the tool part of Figure 1 to be mains-powered; and
Figure 4 illustrates alternative mechanical linkage systems that can be used within the tool part of Figure 1, namely (a) top view of rotary-to-rotary (i) with a top view outline of the housing superimposed and (ii) without the top view of the housing, (b) side view of the system of (a), (c) side view of rotary-to-reciprocating, and (d) side view of rotary-to-oscillating, with, for comparison, the side silhouette of part of the housing being illustrated to the same scale in (e).
Detailed Description of the Drawings
Referring to the drawings, there is shown generally a power tool part of a surgical instrument of the type described above.
The tool comprises the following parts: a housing 1 in pistol-grip configuration having an associated handle part 2; an electric motor 3 disposed within the housing; a battery pack 4 having a connector portion 4a receivable in a chamber within the handle part 2 of the housing 1, which in use provides electrical power to the motor 3; a movable connector device 5a or 5b adapted to be connected with a surgical instrument element (not shown) exteriorly of the housing; linkage means 6 disposed interiorly of the housing 1 between the motor 2 and the connector device 5a,5b for enabling the motor to drive the connector device and the connected surgical instrument element in the appropriate one of rotary, oscillating and reciprocating functionalities; and a finger-operable control device 7 which in use enables the surgeon to control the speed, and optionally also the direction of movement, of the connector device 5a,5b to enable the surgical instrument element connected thereto to perform its surgical utility. The control device 7 may, for example, include a forward/reverse switching function and may control the speed of the motor 3 via a pulse width or other output control system. See Figures 1 to 4.
In the instrument shown in Figure 1, both forms of movable connector device 5a, 5b are illustrated, each fully operational via a multifunctional system of linkages 6. The connector device 5 a is directed orthogonally to the connector device 5b. The housing 1 is provided with two apertures for receiving the two connector devices.
The linkage systems shown in Figure 4 are simpler, in that only one connector device 5a is employed, and only one functionality is provided for it through the linkage system 6. The linkages shown in Figure 4 are thus partial versions of the multifunctional linkage system of Figure 1. In the instruments manufactured using the linkage systems shown in Figure 4, one of the two apertures of the housing will be redundant, and will be sealed off by a separate or integral sealing cover. Where the sealing cover is integral with the remainder of the housing, this may be provided by initially providing the housing with both apertures sealed off by frangible webs (e.g. of plastics), one of which can be removed to prepare the housing part for use. As shown in Figure 4, the linkage system 6 may be provided in modular form for fitting into the housing 1, and the linkage system 6 may be pre-connected to motor 3 to provide a linkage/motor module for fitting into the housing 1.
In more detail, the linkage system 6 illustrated in Figure 4(a) and (b) is a rotary-to- rotary linkage suitable for use in a drill, reamer or screwdriver; the linkage system 6 illustrated in Figure 4(c) is a rotary-to-reciprocating linkage suitable for use in a reciprocating saw; and the linkage system 6 illustrated in Figure 4(d) is a rotary-to- oscillating linkage suitable for use in an oscillating saw.
The tool may alternatively or additionally include features (not shown) including, for example, any one or more of: a membrane switch panel (e.g. of polyester or silicone) (not shown), on the surface of the housing providing multiple function control by finger operation by the surgeon, LEDs or other visual display devices showing the powered/unpowered status indication of the instrument or its functions, the display devices being optionally provided in the membrane switch panel, and/or a separate on/off switch panel.
The tool may be converted from battery power to mains power by means of an adaptor pack 8 which is configured to engage in the battery chamber of the handle part 2 of the housing 1 and to establish appropriate electrical connections to the motor 3, analagously to the battery-powered tool. The adaptor pack is connectable to a mains power supply 9 via a conventional cable 10.
The electrical parts are controlled by means of conventional circuitry mounted on a printed circuit board (not shown). Such circuitry will suitably include transformers, converters and regulators in conventional manner, whereby the tool is functional for battery power or for mains power in more than one main voltage as conventionally used internationally, and the risk of possibly lethal electric shocks from faults or failures is reduced. It is preferred that all international mains voltages are catered for. For example, the circuitry may includes more than one - e.g. three - mutually independent power converters, to reduce the risk of failure of power output during a surgical procedure.
An input converter may preferably incorporate an active power factor correction unit using average mode control on the incoming mains, together with a suitable controller, to compensate for possible current surges or fluctuations.
An output converter may preferably incorporate a synchronous current mode switching regulator and a suitable controller.
The intermediate converter between the input and output converters, or any one of more than one intermediate converters, may preferably be or include a phase shift full bridge converter and a suitable controller.
The circuitry further incorporates a device providing for pulse width modulation for control of the output speed of the motor 3, in conventional manner, under the control of the surgeon via the fmger-operatable control device 7.
The power tools illustrated provide the basis for a wide range of single-use and repeat-use surgical instruments, as has already been described, hi the case of a single-use instrument, the battery pack 2 (or adaptor 8) and optionally also the instrument element used will be disconnected from the remainder of the tool after use, and the tool discarded or recycled. In the case of a repeat-use instrument, the battery pack 2 (or adaptor 8) and the instrument element used will be disconnected from the remainder of the tool after use and all the parts will be cleaned and sterilised for reuse.
hi the case of a repeat-use tool, an effective seal is required around the apertures of the housing 1 where the connector device(s) is/are located, and the design of the housing 1 should be such that crevices where possibly infectious agents can collect are minimised or eliminated.
The parts are preferably provided in modular form, whereby the tool can easily be assembled in mass production according to the method of the present invention described above. At least the housing 1, and optionally also any one or more of the motor 3, the power supply unit 4, the mechanical linkage system 6, the mains adaptor 8 and the circuitry and accessories are standard for a range of instruments, which provides considerable logistical and economic advantages to the production scale manufacture.
Where single-use instruments are desired, the connector device 5a,5b is preferably adapted to be non-releasably connected to the surgical instrument element as described generally above, and in the said assembly process the surgical instrument element is preferably non-releasably connected to the connector device 5a, 5b of the tool. The assembly procedure is preferably fully performed on a production scale in the factory environment.
Where repeat-use instruments are desired, the connector device 5 a, 5b is preferably adapted to be releasably connected to the surgical instrument element as described generally above, and in the said assembly process the surgical instrument element is preferably releasably connected to the connector device 5a,5b of the tool. The assembly procedure may be fully performed on a production scale in the factory environment, or may be performed on a production scale in the factory environment to the extent of providing the tools and the instrument elements separately, which are then releasably connected together on a single-instrument scale in each operating theatre environment to which the products of the factory have been supplied. Industrial Applicability
The present invention provides substantial advantages in the manufacture of electrically powered surgical instruments.
The use of a single housing and optionally other standard parts for power tools to serve the full range of instrument elements of a set enables the component supply and storage systems to be greatly simplified and made more economical, in comparison with known manufacturing methods.
The preferred use of modular parts of the power tools, for example the mechanical linkage systems, the power sources and/or motor enables a wide range of instruments, both single-use and repeat-use, to be manufactured easily and economically, based on the standard basic combination of housing, motor and power supply means.
The foregoing broadly describes the present invention without limitation. Variations and modifications as will be readily apparent to those skilled in this art are intended to be within the scope of the present application.

Claims

1. A method of manufacturing a range of electrically powered surgical instruments of different functionalities on a production scale, the surgical instruments comprising a surgical instrument element portion associated with, and driven in use by, a power tool portion, the method comprising, in any suitable order:
(i) providing on a production scale a plurality of surgical instrument elements having functionality types selected from two or three, preferably all three, of: rotary-type, oscillating-type and reciprocating-type surgical instrument elements, each of the surgical instrument elements being adapted to be connected to a surgical power tool to provide an electrically powered surgical instrument;
(ii) providing on a production scale parts for constructing a plurality of surgical power tools for all the said surgical instrument elements, each tool comprising the following parts:
(a) a housing having an associated handle part, (b) an electric motor adapted to be disposed within the housing,
(c) means which in use transmit electrical power to the motor,
(d) a movable connector device adapted to be connected with a surgical instrument element exteriorly of the housing,
(e) linkage means adapted to be disposed interiorly of the housing between the motor and the connector device for enabling the motor to drive the connector device and the connected surgical instrument element in the appropriate one of rotary, oscillating and reciprocating functionalities, and
(f) means which in use control the connector device to enable a surgical instrument element connected thereto to perform its surgical utility, at least the part (a) being the same for each tool and suitable for use with all of the said surgical instrument elements;
(iii) in any suitable order, assembling the parts and connecting an appropriate surgical instrument element to the connector device, to provide on a production scale either the plurality of surgical power instruments each comprising a tool and an instrument element, or a plurality of tools and instrument elements from which the surgical instruments can be assembled.
2. A method according to claim 1, wherein the set of surgical instrument elements comprises all three of: rotary-type, oscillating-type and reciprocating-type surgical instrument elements.
3. A method according to claim 1 or claim 2, wherein the surgical instrument is a single-use instrument.
4. A method according to claim 3, wherein the connector device is adapted to be non-releasably connected to the surgical instrument element and in the said assembly process the surgical instrument element is non-releasably connected to the connector device of the tool.
5. A method according to claim 3 or claim 4, wherein the assembly procedure is preferably fully performed in the factory environment.
6. A method according to claim 1 or claim 2, wherein the surgical instrument is a repeat-use instrument.
7. A method according to claim 6, wherein the connector device is adapted to be releasably connected to the surgical instrument element and in the said assembly process the surgical instrument element is releasably connected to the connector device of the tool.
8. A method according to claim 6 or claim 7, wherein the assembly procedure is fully performed in the factory environment.
9. A method according to claim 6 or claim 7, wherein the assembly procedure is performed in the factory environment to the extent of providing the tools and the instrument elements separately, which are then releasably connected together in the operating theatre environment.
10. Electrically powered surgical instruments manufactured using a manufacturing method according to any one of the preceding claims.
11. Surgical instruments according to claim 10, being single-use instruments manufactured using a manufacturing method according to any one of claims 3 to 5.
12. Surgical instruments according to claim 10, being repeat-use instruments manufactured using a manufacturing method according to any one of claims 6 to 9.
13. A surgical power tool portion for use in an electrically powered surgical instrument, the power tool portion comprising:
(a) a housing having an associated handle part,
(b) an electric motor disposed within the housing, and
(c) means which in use transmit electrical power to the motor,
wherein the means for transmitting power to the motor comprise electrical contacts and circuitry which can cooperate with a battery pack or mains adaptor pack having corresponding electrical contacts to transmit electrical power to the power transmitting means (c), whereby the tool is adaptable to run from battery or mains power source by appropriate selection of a battery pack or a mains adaptor pack to connect with the power transmitting means (c) of the surgical power tool.
14. A surgical power tool portion according to claim 13, wherein the battery pack or mains adaptor pack is separable from the tool.
15. A surgical power tool portion according to claim 13 or claim 14, farther comprising:
(d) a movable connector device adapted to be connected with the surgical instrument element exteriorly of the housing, (e) linkage means disposed interiorly of the housing between the motor and the connector device for enabling the motor to drive the connector device and the connected surgical instrument element in the appropriate one of rotary, oscillating and reciprocating functionalities, and (f) means which in use control the connector device to enable a surgical instrument element connected thereto to perform its surgical utility.
16. A surgical power tool portion according to claim 15, being a portion of an instrument according to any one of claims 10 to 12.
17. An electrically powered surgical instrument comprising a surgical instrument element portion associated with, and driven in use by, a power tool portion according to any one of claims 13 to 16.
18. A method of manufacturing electrically powered surgical instruments substantially as herein described with reference to the accompanying drawings.
19. Electrically powered surgical instruments manufactured using a manufacturing method substantially as herein described with reference to the accompanying drawings.
20. Surgical power tool portions of electrically powered surgical instruments, substantially as herein described with reference to the accompanying drawings.
PCT/GB2007/000442 2006-02-07 2007-02-07 Method of manufacturing electrically powered surgical instruments, and electrically powered surgical instruments manufactured thereby WO2007091074A2 (en)

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