INSTRUMENT

FIELD OF THE INVENTION

[0001] The present invention relates to minimally invasive and diagnostic procedures and more particularly to an apparatus for protecting electronic devices and components associated with instruments during the procedures or during sterilization.

BACKGROUND

[0002] Traditional open surgery uses medical tools and techniques that put clinicians in direct contact with tissue at the surgical site. In order to significantly reduce the amount of dissection required to access the surgical site, traditional surgery is being replaced with minimally invasive surgery and diagnostic procedures.

[0003] Minimally invasive surgery and diagnostic procedures are methods of accessing the internal organs of the body where instruments are inserted into the body through small incisions which also include, but is not limited to, natural orifices such as, but not limited to, the mouth, rectum, urethra, or vagina and limited access incisions such as, but not limited to, access in spinal surgery. Minimally invasive instruments may be rigid, flexible, semi-rigid, or any combination thereof, and typically consist of a proximal handle, an elongated member extending from the handle, and a distal end effector. In operation, the minimally invasive instruments are inserted into the body through trocars which provide a conduit for minimally invasive instruments with end effectors, such as, graspers, snares, scissors, needles, or retractors. Generally, the trocar is inserted into the body through a small incision dimensioned to fit the sharp, removable tip of the trocar, and the trocar is advanced into the body until the tip reaches the surgical site. In use, clinicians operate the proximal handle which controls the end effector inside the body through the medial shaft body, from outside the body. In addition to creating the channels into the body and protecting the surrounding tissue from damage from tool friction, the trocars can also act as a port for injecting a gas, such as nitrogen, oxygen, or air into the cavity to expand the cavity and create a larger working area for the minimally invasive instruments. The gap between the minimally invasive instrument and trocar is minimized to prevent the gas from escaping.

[0004] The minimally invasive instruments can also be operated robotically with the proximal handle being replaced by an interface to a robot. These minimally invasive instruments are typically operated with only video feedback provided by an endoscope. However, the remote operation of the minimally invasive instruments can make it more difficult to monitor and control the multitude of variables associated with a procedure. Accordingly, electronics and sensors may be incorporated into minimally invasive instruments to assist in monitoring and controlling the variables associated with a procedure. The electronics and sensors may include, but not limited to, force sensors, video or image capture, bioelectric signal sensing, or any combination thereof.

[0005] According to standard infection control practices and protocol, any minimally invasive instruments that enter an already aseptic part of the body must be sterile, in order to substantially minimize or prevent patient-to-patient cross- infection. One of the most common method for sterilizing instruments involves the use of an autoclave, either a steam autoclave or a chemical vapour autoclave. Autoclavable minimally invasive instruments have typically been manufactured entirely from stainless steel or other metals that are substantially non-degradable in body fluids. However, for minimally invasive instruments containing electronics and sensors that are sensitive to both moisture and heat, the use of autoclave presents a challenge. Various approaches have been developed to protect the electronics but still allow the minimally invasive instrument to be sterilized. In one approach, the instrument is enveloped with a disposable cover such that the instrument is never in contact with the patient. In another approach, a minimally invasive instrument with an altemative sterilization method such as, but not limited to, chemical, UV, or gamma sterilization. A variation on these two approaches involves having the electronics portion of the surgical device being detachable from the rest of the minimally invasive instrument. Accordingly, the rest of the minimally invasive instrument can be autoclaved and the electronics can either have a disposable cover during the procedure to avoid sterilization all together, or the electronics may be sterilized using an alternative sterilization method. In yet another approach, the electronics are completely encased or sealed such that they do not come into contact with moisture, and the electrical components are specially selected to resist heat. The sealing is accomplished by epoxy or adhesive potting or encapsulation, welding, or a combination thereof.

[0006] However, none of these approaches allow autoclaving of the entire device while still allowing quick, non-destructive, tool-less access to the electronics for operation such as, but not limited to, battery replacement, calibration, repair, component replacement or upgrade, and/or any combination thereof.

[0007] It is an object of the present invention to mitigate or obviate at least one of the above-mentioned disadvantages.

SUMMARY OF THE INVENTION

[0008] In one of its aspects, there is provided an enclosure disposed on an instrument, the enclosure comprising:

a shell and a core, the core circumferentially surrounded by the shell when disposed on a shaft of the instrument to form at least one cavity;

at least one sealing element to seal the at least one cavity, such that the at least one sealing element is disposed at any interface between any of the core, the shell, and the shaft.

[0009] In another of its aspects, there is provided an enclosure disposed on an instrument, the enclosure comprising:

a shell and a core, the core circumferentially surrounded by the shell when disposed on a shaft of the instrument to form at least one cavity;

at least one sealing element to seal the at least one cavity, such that the at least one sealing element is disposed at any interface between any of the core, the shell, and the shaft; and

wherein the enclosure is removably attached to the instrument.

[0010] In another of its aspects, there is provided an enclosure for an minimally invasive instrument, the enclosure comprising: an autoclavable shell and an autoclavable core, the core

circumferentially surrounded by the shell when disposed on a shaft of the minimally invasive instrument to form a cavity for housing at least one component;

a first sealing element, a second sealing element and a third sealing element to seal the at least one cavity, such that the first sealing element is disposed at a first interface between the shell and the core; the second sealing element is disposed at any interface between the core and the shaft; and the third sealing element is disposed at any interface between the shell and the shaft.

[0011] In another of its aspects, there is provided an enclosure for a minimally invasive instrument, the enclosure comprising:

an autoclavable shell and an autoclavable core, the core circumferentially surrounded by the shell when disposed on a shaft of the minimally invasive instrument to form at least one cavity for housing at least one component;

at least one sealing element to seal the at least one cavity, such that the at least one sealing element is disposed at any interface between any of the core, the shell, and the shaft; and

the enclosure being removably attached to the instrument; and whereby the at least one sealing element exerts a sealing force perpendicular to the shaft such that a seal between the shell and an core is maintained without additional forces or fasteners.

[0012] In another of its aspects, there is provided an instrument comprising:

an enclosure comprising:

a shell and a core, the core circumferentially surrounded by the shell when disposed on a shaft of the instrument to form at least one cavity;

at least one component housed in the at least one cavity, the at least one component being communicatively coupled to at least one external device via a substrate comprising an electrical conductive medium;

at least one sealing element to seal the at least one cavity, such that the at least one sealing element is disposed at any interface between any of the core, the shell, and the shaft;

wherein the substrate comprising the electrical conductive medium is releasably connected to the at least one component within the enclosure, and traverses any interface between any of the core, the shell, and the shaft, without affecting the integrity of the seal; and wherein the enclosure is removably attached to the instrument.

[0013] Advantageously, the enclosure allows autoclaving of the entire device, and facilitates quick, non-destructive, tool-less access to the electronics for operation such as, but not limited to, battery replacement, calibration, repair, component replacement or upgrade, and/or any combination thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Several exemplary embodiments of the present invention will now be described, by way of example only, with reference to the appended drawings in which:

[0015] Figure la shows an exploded view of an instrument, in one exemplary implementation;

[0016] Figure lb shows an exploded view of an enclosure on a medial portion of a shaft of the instrument of Figure la, in one exemplary implementation;

[0017] Figures 2a to 2d show cross sectional views of an enclosure on a shaft of the instrument with various sealing configurations, in other exemplary implementations;

[0018] Figure 3 shows a cross sectional view of an enclosure on a shaft of the instrument with a plurality of shelled cavities, in another exemplary implementation;

[0019] Figure 4 shows a cross sectional view of an enclosure on an end of the shaft of the instrument, in another exemplary implementation;

[0020] Figure 5a shows a cross sectional view of an enclosure on a medial portion of a shaft of the instrument and separable from the instrument, in another exemplary implementation; [0021] Figure 5b shows a cross sectional view of an enclosure on a medial portion of a shaft of the instrument and separable from the instrument, in another exemplary implementation; and

[0022] Figure 6 shows a cross sectional view of an enclosure on a shaft of the instrument and is separable from the instrument, in yet another exemplary implementation.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0023] The detailed description of exemplary embodiments of the invention herein makes reference to the accompanying block diagrams and schematic diagrams, which show the exemplary embodiment by way of illustration. While these exemplary embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, it should be understood that other embodiments may be realized and that logical and mechanical changes may be made without departing from the spirit and scope of the invention. Thus, the detailed description herein is presented for purposes of illustration only and not of limitation. For example, the steps recited in any of the method or process descriptions may be executed in any order and are not limited to the order presented.

[0024] Moreover, it should be appreciated that the particular implementations shown and described herein are illustrative of the invention and its best mode and are not intended to otherwise limit the scope of the present invention in any way. Connecting lines shown in the various figures contained herein are intended to represent exemplary functional relationships and/or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may be present in a practical system.

[0025] Figure la shows an exemplary instrument 10, such as a minimally invasive instrument for use in minimally invasive procedures. In more detail, with elongate medial shaft body 12 having thereon enclosure 13 accommodating components, such as device module 14, and power source 16. Enclosure 13 comprises core 20 on shaft body 12, and shell 22, such that core 20 is received by shell 22. Core 20 further comprises first sealing channel 24 which receives first sealing element 25 to sealingly engage core 20 to shell 22, and shell 22 comprises second sealing channel 26 which receives second sealing element 27 to sealingly engage shell 22 to shaft body 12 by second sealing channel 26. Accordingly, with shell 22 sealingly engaged to core 20 cavity 28 is formed therebetween. Cavity 28 may include multiple compartments 29, 30 which can accommodate components, such as device module 14, and power source 16, comprising batteries and associated circuitry. Sealing elements 25, 27 may comprise any suitable element capable of providing a seal to substantially minimize or prevent ingress of fluid into cavity 28.

[0026] In more detail, as shown in Figures 2a to 2d, enclosure 13 comprises shell 22 and core 20, such that core 20 is circumferentially surrounded by shell 22, and both shell 22 and core 20 surround medial shaft body 12 of the minimally invasive instrument 10.

[0027] In Figure 2a, shell 22, core 20, and/or shaft 12 are sealingly engaged to each other by sealing elements 25, 27, such that cavity 28 is sealed. The one or more seals are created by two or more sealing elements 25, 27 placed circumferentially about either or both of core 20 or shell 22. When core 20 or shaft 12 is placed inside shell 22 sealing element 25 is pinched between shell 22 and core 20, and sealing element 27is pinched between shell 22 and shaft 12, respectively, thereby creating the seals. Once shell 22 is placed over shaft 12 and core 20 the pinching force is perpendicular to medial shaft body 12 to maintain the seal. Preferably, one or more sealing elements 25, 27 is circular to evenly distribute the pinching force which creates the one or more seals. Preferably, the first sealing element 25 is formed by an O-ring on core 20 which is pinched by the shell 22, while the second sealing element 27 is formed by an internal O-ring on the shell 22 which is pinched by the shaft 12. When O-rings 25, 27 are used, the circular, circumferential interface of sealing channels 24, 26 mimics the rated configuration of O-rings 25, 27 which allows the extensive testing and technical standards of standard O-rings to be applied to the design of the enclosure 13 in order to improve reliability and robustness.

[0028] As shown in the various configurations of core 20 and shell 22 in

Figures 2b to 2d, sealing elements 25, 27 may be implemented by a combination of fixing either or neither of core 20 or shell 22 to shaft 12 and by having the two or more sealing elements 25, 27, and 31, on either core 20 or shell 22, or both.

[0029] Components inside sealed cavity 28 may communicate with other systems or sensors outside of the enclosure 13 by means of, but not limited to, mechanical transmission, acoustic transmission, optical transmission, radio transmission, flexible circuit board, electrical wires, electrical spring contacts, magnetic coupling, capacitive coupling, or any combination thereof, and using sealing methods where required. In one exemplary implementation, the method of communicating with other systems or sensors outside enclosure 13 comprises a flexible circuit board passed between one or more sealing elements 25, 27 and their respective pinching surfaces such that the thin profile of the flexible circuit board does not break the seal. For example, a component, such as device module 14 comprises a wireless transceiver, analog frontend, and battery 18, and communicates with a force sensor on the surface of enclosure 13. Device module 14 or a selection thereof may or may not be additionally protected against moisture by a conformal coating, epoxy, or similar.

[0030] In another exemplary implementation, enclosure 13 may have a plurality of shells 40, 41 and core 42 sealed together by sealing element 43 received in sealing channel 44; sealing element 45 received in sealing channel 46; sealing element 47 received in sealing channel 48; and sealing element 49 received in sealing channel 50, as shown in Figure 3. Accordingly, a sealed cavity 51 is formed between shells 40, 41 and core 42 and may include multiple compartments as desired, such as compartments 52 and 53. Enclosure 13 may also include components (not shown) within the sealed cavity 51 protected with other protection methods such as, but not limited to, potting, conformal coating, shielding cans, cracked ferrite, conductive tap, or any combination thereof.

[0031] Now turning to Figure 4, there is shown a portion of instrument 10 comprising enclosure 72 with core 74 and shell 76, at one end 78 of shaft 80 of instrument 10, in another exemplary implementation. Enclosure 72 comprises a single cavity 82 sealed by a single sealing element 84 received by sealing channel 85. In one example, sealing element 84 is an O-ring which is pinched by shell 76. Components (not shown) in cavity 82 communicate with sensing elements associated with instrument 10 via a flexible circuit board, such as conductive sensor film 83. Generally, sensor film 83 comprises a substrate with a conductive medium, such as metal traces, coupled to sensing elements (not shown), to transfer signals between the sensing elements, or other devices associated with instrument 10, such as end effectors, and the components in cavity 82. Generally, sensor film 83 is placed onto elongate shaft body 80, and secured thereto by attachment means. The substrate is relatively thin, and is secured onto the elongate shaft body 80 without any protrusions or flaps, such that sensor film 83 is flush with shaft 80, and such that the integrity of any seal formed between enclosure 72 and shaft 80 is not compromised.

[0032] Accordingly, enclosure 72 is pushed onto proximal end 78 of instrument 10 via an opening 86 in core 74 into core bore 88, until proximal end 78 abuts end wall 89 of core bore 88, and sensor film 83 is connected to components via a connection interface (not shown). As can be seen in Figure 4, instrument 10 lacks a handle at proximal end 78, and thus enclosure 72 may be suitable for any similarly-configured instrument that are handheld or held between the thumb and one or more fingers, e.g. a pencil grip, such as dental instruments or surgical instruments. As such, enclosure 72, including components, such as device module(s) and power source, may be removably attached to proximal end 78 of shaft body 80 (as indicated by the double arrow in Figure 4). Accordingly, instrument 10 may be sterilized separately or independent of enclosure 72. In addition, enclosure 72 may be a disposable, which may be discarded after a single use or after a predetermined number of uses.

[0033] In another example, enclosure 72 is associated with elongate shaft body 80 with proximal end 78 and a distal end with an end effector assembly operable by manipulation of actuator mechanism (not shown) at proximal end 78. Accordingly, actuator mechanism and end effector assembly are interconnected via a push rod or wire (not shown) within elongate shaft body 80.

[0034] With reference to Figure 5 a, there is shown a portion of instrument

10 comprising enclosure 72 with core 74 and shell 76, at proximal end 78 of shaft 80 of instrument 10, in another exemplary implementation. Proximal end 78 comprises mechanical stop 90, and enclosure 72 comprises cavity 92 sealed by three sealing elements 94, 96 and 98, received by sealing channels 100, 102 and 104, respectively. The first seal is formed by pinching sealing element 94 between shell 76 and core 74; the second seal is formed by pinching sealing element 96 between core 74 and instrument shaft 80; and the third seal is formed by pinching sealing element 98 between shell 76 and instrument shaft 80. Both shell 76 and core 74 are movable thereby allowing the entire enclosure 72 to be removably separable surgical instrument 10 (as indicated by the double arrows in Figure 5a). Accordingly, mechanical stop 90 limits lateral motion of enclosure 72 along shaft 80, and allows for proper positioning of enclosure 72.

[0035] Similar to the exemplary implementation shown in Figure 4, enclosure 72 of Figure 5a comprises components, such as device module(s) and power source(s) in cavity 92, and components communicate with sensing elements associated with instrument 10 via a flexible circuit board, such as conductive sensor film 106. Generally, sensor film 106 comprises a substrate with a conductive medium, such as metal traces, coupled to sensing elements (not shown), to transfer signals between the sensing elements, or other devices associated with instrument 10, such as end effectors, and the components in cavity 90. Sensor film 106 is placed onto elongate shaft body 80, and secured thereto by attachment means. The substrate is relatively thin, and is secured onto the elongate shaft body 80 without any protrusions or flaps, such that is sensor film 106 is flush with shaft 80, and such that the integrity of any seal formed between enclosure 72 and shaft 80 is not compromised. Sensor film 106 comprises end 108 with a series of spaced apart, electrically isolated, metallized rings 110 wrapped around shaft body 80, and core 74 comprises a corresponding series of spaced apart, resiliently biased electrical contacts 112, such as spring loaded pogo-stick type contacts, coupled to the device module. Via electrical interface 113 formed between the spring loaded pogo-stick type contacts 112 electrical signals or power are transferred between the components and metallized rings 110 coupled to sensor film 106, which is in turn coupled to the sensing elements. Advantageously, when enclosure 72 abuts mechanical stop 90 then spring loaded pogo-stick type contacts 112 are properly aligned with metallized rings 110, and therefore an electrical connection is effected therebetween. Given the annular nature of metallized rings 110 around shaft 80, once enclosure 72 is properly positioned on shaft 80 then spring loaded pogo-stick type contacts 112 are caused to always make contact with metallized rings 110. Accordingly, even if enclosure 72 is rotated about shaft 80, the electrical contact between spring loaded pogo-stick type contacts 112 and metallized rings 110 is maintained, as long as enclosure 72 is properly positioned. Accordingly, enclosure 72 can be easily applied to instrument 10 and positioned for proper interface with metallized rings 110 without having to deal with alignment issues, with minimal hand-eye coordination being required.

[0036] With reference to Figure 5b, there is shown a portion of instrument

10 comprising enclosure 72 with core 74 and shell 76, at proximal end 78 of shaft 80 of instrument 10, in another exemplary implementation. Proximal end 78 comprises mechanical stop 90, and enclosure 72 comprises cavity 92 sealed by two sealing elements 120 and 122, received by sealing channels 124 and 126, respectively. The first seal is formed by pinching sealing element 120 between shell 76 and core 74; second seal is formed by pinching sealing element 122 between core 74 and shell 76. Both shell 76 and core 74 are movable thereby allowing the entire enclosure 72 to be removably separable surgical instrument 10 (as indicated by the double arrows in Figure 5b). Accordingly, mechanical stop 90 limits lateral motion of enclosure 72 along shaft 80, and allows for proper positioning of enclosure 72, as described above.

[0037] Similar to the exemplary implementation shown in Figure 5a, enclosure 72 of Figure 5b comprises components, such as device module(s) and power sources in cavity 92, and the components communicate with sensing elements associated with instrument 10 via a flexible circuit board, such as conductive sensor film 130. Similar to sensor film 106, sensor film 130 comprises end 132 with a series of spaced apart, electrically isolated, metallized rings 134 wrapped around shaft body 80, and core 74 comprises a corresponding series of spaced apart, resiliently biased electrical contacts 136, such as spring loaded pogo-stick type contacts, coupled to the device module. Via electrical interface 137 formed between spring loaded pogo-stick type contacts 136 and metallized rings 134, electrical signals or power are transferred between the components and sensor film 130 coupled to the sensing elements, or other devices associated with instrument 10. The spring loaded pogo-stick type contacts 136 allow for the transfer of electrical signals or power between the device module and metallized rings 134 coupled to sensor film 130, which is in turn coupled to the sensing elements. Advantageously, when enclosure 72 abuts mechanical stop 90 then spring loaded pogo-stick type contacts 136 are properly aligned with metallized rings 134, and therefore an electrical connection is effected therebetween. As described above, once enclosure 72 is properly positioned on shaft 80 then spring loaded pogo-stick type contacts 136 always make contact with metallized rings 134, even if enclosure 72 is rotated about shaft 80,given the annular nature of metallized rings 134 around shaft 80. Accordingly, enclosure 72 can be easily applied to instrument 10 and positioned for proper interface with metallized rings 134 without having to deal with alignment issues, as described above.

[0038] Referring now to Figure 6, there is shown a portion of instrument

10 comprising enclosure 72 with core 74 and shell 76, at proximal end 78 of shaft 80 of instrument 10, in another exemplary implementation. Enclosure 72 comprises a single cavity 140 sealed by two sealing elements 142 and 144, received by sealing channels 146 and 148, respectively. The first seal is formed by pinching sealing element 142 between core 74 and shaft 80, and the second seal is formed by pinching sealing element 144 between core 74 and shell 76. Both shell 76 and core 74 are movable thereby allowing the entire enclosure 72 to be removably separable surgical instrument 10 (as indicated by the double arrows in Figure 6). As described above, components in cavity 140 communicate with sensing elements and other devices associated with instrument 10 via a flexible circuit board, such as conductive sensor film 150. Generally, sensor film 150 comprises a substrate with a conductive medium, such as metal traces, coupled to sensing elements (not shown), to transfer signals between the sensing elements, or other devices associated with instrument 10, such as end effectors, and the components in cavity 140. Generally, sensor film 150 is placed onto elongate shaft body 80, and secured thereto by attachment means. The substrate is relatively thin, and is secured onto the elongate shaft body 80 without any protrusions or flaps, such that sensor film 150 is flush with shaft 80, and such that the integrity of any seal formed between enclosure 72 and shaft 80 is not compromised. Accordingly, enclosure 72 is pushed onto proximal end 78 of instrument 10 via an opening 152 in core 74 into core bore 154, until proximal end 78 abuts end wall 156 of core bore 154, and sensor film 150 is connected to device module via a connection interface 158.

[0039] As can be seen in Figure 6, instrument 10 lacks a handle at proximal end 78, and thus removable enclosure 72 may be suitable for any similarly- configured instrument that are handheld or held between the thumb and one or more fingers, e.g. a pencil grip, such as dental instruments or surgical instruments. As such, enclosure 72, including components, such as device module(s) and a power source, may be removably attached to proximal end 78 of shaft body 80 (as indicated by the double arrow in Figure 6). Accordingly, instrument 10 may be sterilized separately or independent of enclosure 72. In addition, enclosure 72 may be a disposable, which may be discarded after a single use or after a predetermined number of uses. Similar to the exemplary embodiment shown in Figure 4 and Figures 5a and 5b, the components in cavity 140 of instrument 10 of Figure 6, communicate with sensing elements associated with instrument 10 via conductive sensor film 150 via interface 158.

[0040] Similar to sensor film 106, sensor film 150 comprises one end 160 with a series of spaced apart, electrically isolated, metallized rings 162 wrapped around shaft body 80, and core 74 comprises a corresponding series of spaced apart, resiliently biased electrical contacts 164, such as spring loaded pogo-stick type contacts, coupled to the components, such as a device module in enclosure 72. Via electrical interface 158 formed between spring loaded pogo-stick type contacts 164 and metallized rings 162, electrical signals or power are transferred between the components and sensor film 150 coupled to the sensing elements, or other devices associated with instrument 10. Advantageously, when proximal end 78 of shaft 80 abuts end wall 156 of core bore 154 then spring loaded pogo-stick type contacts 164 are properly aligned with metallized rings 162, and therefore an electrical connection is effected therebetween. As described above, given the annular nature of metallized rings 134 around shaft 80, once enclosure 72 is properly positioned on shaft 80 then spring loaded pogo-stick type contacts 164 always make contact with metallized rings 162, even if enclosure 72 is rotated about shaft 80. Accordingly, enclosure 72 can be easily applied to instrument 10 and positioned for proper interface with metallized rings 162 without having to deal with alignment issues.

[0041] In one exemplary implementation, the core and the shell are composed of biocompatible material that is capable of resisting autoclaving steam, temperatures, and pressures such as, but not limited to, polyether ether ketone (PEEK), polyetherimide (PEI), polyphenylsulfone (PPSF), polysulfone, stainless steel, titanium, PTFE, FEP, silver, gold, platinum, palladium, or any combination, lamination, coating, composite, or alloy thereof.

[0042] In one exemplary implementation, sealing elements 25, 27, 43, 47,

84, 94, 98, 102, 104, 120, 122, 142, and 144 are composed of a biocompatible material that is capable of resisting autoclaving steam, temperatures, and pressures and is sufficiently soft such that it can deform to form a seal. The sealing material may be, but is not limited to, fluorosilicone, FEP-coated silicone, perfluoroelastomer (FFKM/FFPM), ethylene propylene diene monomer (EPDM), polytetrafluoroethylene (PTFE), or any combination, composite, or coating thereof. Sealing elements 25, 27, 43, 47, 84, 94, 98, 102, 104, 120, 122, 142, and 144may be made easily removable such that less autoclave resistant materials such as silicone can be regularly replaced.

[0043] In one exemplary implementation, enclosure 13 or enclosure 72 comprise an enclosure material selected to fulfill a variety of requirements, such as physical protection for the components, and sealing off the components from the elements during autoclave sterilization, or during a procedure, and offering resistance to alternative sterilization methods such as, but not limited to, chemical, UV, or gamma sterilization.

[0044] In another exemplary implementation, the enclosure material is radiolucent, such that the components may communicate wirelessly using radio waves to an external device through the radiolucent enclosure material. Alternatively, the enclosure material may include association with an antenna coupled to the components. For example, the antenna may be embedded in the enclosure material, or the antenna may be affixed on the exposed surface of the enclosure material.

[0045] In another exemplary implementation, the enclosure material comprises non-magnetic and non-conductive properties. Other additional requirements comprise providing electrical shielding from radiated, conductive, capacitive, or inductive/magnetic interference or noise.

[0046] In another exemplary implementation, enclosure 13 or 74 acts as a capacitive touch interface or button. External devices comprise any one of input/output devices affixed on an exterior of enclosure 13, sensing elements affixed on an exterior of enclosure 13, other instruments, and diagnostic devices and computing devices.

[0047] In another implementation, the components communicate with external devices via magnetic self-aligning electrical connectors, such as resiliently- biased spring contacts with magnetic alignment. Accordingly, external device and enclosure material comprise male and female coupling halves, respectively. The male coupling half of the external device comprises magnetic means therein and fixed electrical contact means proj ecting beyond one face thereof. The female coupling half of the enclosure material has magnet means therein for cooperation with the magnet means in the male coupling half for holding the coupling halves together, and electrical contact means. When the coupling halves are brought together, the magnet means holds the coupling halves together against relative displacement therebetween, the electrical contact means of the external device and the electrical contact means of the enclosure materials are in substantial alignment with each other to make electrical connection therebetween. The magnetic self- aligning electrical connectors allow for quick and easy connections with only minimal hand and eye coordination required.

[0048] In yet another preferred method of communicating, the case material is used as capacitive touch interface as aforementioned in the selection of enclosure materials. [0049] In yet another implementation, the components accommodated by the enclosure 13 or 72 comprises any one of: electronic devices, electronic components, printed circuit board, electronic module, integrated chip, a Lab-on- Chip, electronic circuitry, power source, power circuitry, and a battery.

[0050] In yet another implementation, the enclosure material may comprises a display for relaying information to a clinician. The display may include, but is not limited to, ceramic LEDs or LCD screen. The display may use a sealed protective light transmitting layer comprising of, but not limited to, glass, PEI, polyimide, polycarbonate, or any combination or lamination thereof.

[0051] In another exemplary implementation, the core and the shell are fixed to the shaft by, but not limited to, sealing elements, ultrasonic welding, epoxy, cyanoacrylate, urethane adhesive, acrylic adhesive, solvent welding, set screw, mechanical interlock, or any combination thereof.

[0052] In another exemplary implementation, the core and the shell are sealed to create a cavity within the enclosure by, but not limited to, sealing elements, ultrasonic welding, epoxy, cyanoacrylate, urethane adhesive, acrylic adhesive, solvent welding, set screw, mechanical interlock, or any combination thereof.

[0053] In another exemplary implementation, when the shell is placed over the shaft body of the instrument and the core the pinching force exerted by the sealing element is perpendicular to the medial shaft body to maintain the seal without the requirement for additional forces, such as forces provided by fasteners, and so forth.

[0054] In another exemplary implementation, the enclosure may be affixed to the shaft by ultrasonic welding, epoxy, cyanoacrylate, urethane adhesive, acrylic adhesive, solvent welding, set screw, mechanical interlock, or any combination thereof. Accordingly, the instrument and the enclosure are inseparable and may be sterilized together as one unit.

[0055] In another exemplary implementation, the core and the shell are sealed to create a cavity within enclosure by, but not limited to, sealing elements, ultrasonic welding, epoxy, cyanoacrylate, urethane adhesive, acrylic adhesive, solvent welding, set screw, mechanical interlock, or any combination thereof. [0056] In another implementation, the minimally invasive instrument 10 described in the respective exemplary implementations of Figures 4, 5a, 5b. and 6, comprise an autoclavable enclosure with an electronics module sealed in at least one cavity and enclosure material similar to the exemplary implementation of Figures lb, 2a-2d and 3.

[0057] While these exemplary implementations are described in sufficient detail to enable those skilled in the art to practice the invention, it should be understood that other exemplary implementations may be realized and that logical and mechanical changes may be made without departing from the spirit and scope of the invention. The preceding detailed description is presented for purposes of illustration only and not of limitation, and the scope of the invention is defined by the preceding description, and with respect to the attached claims.