US20190298467A1 - Polymeric gloves having embedded surgical support systems and discrete elements - Google Patents
Polymeric gloves having embedded surgical support systems and discrete elements Download PDFInfo
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- US20190298467A1 US20190298467A1 US16/377,601 US201916377601A US2019298467A1 US 20190298467 A1 US20190298467 A1 US 20190298467A1 US 201916377601 A US201916377601 A US 201916377601A US 2019298467 A1 US2019298467 A1 US 2019298467A1
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- glove
- surgical
- switch
- proximity switch
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- GDOPTJXRTPNYNR-UHFFFAOYSA-N CC1CCCC1 Chemical compound CC1CCCC1 GDOPTJXRTPNYNR-UHFFFAOYSA-N 0.000 description 1
- 0 CCCCCCCCC(CCI=C=I)(C*(CCCC*CC(C)C)CC(F)(F)F)ICCC Chemical compound CCCCCCCCC(CCI=C=I)(C*(CCCC*CC(C)C)CC(F)(F)F)ICCC 0.000 description 1
- FMTRYGAFQUQIEX-UHFFFAOYSA-N CCCCC[F]C Chemical compound CCCCC[F]C FMTRYGAFQUQIEX-UHFFFAOYSA-N 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B42/00—Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
- A61B42/10—Surgical gloves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B42/00—Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
- A61D19/00—Instruments or methods for reproduction or fertilisation
- A61D19/04—Instruments or methods for reproduction or fertilisation for embryo transplantation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
- A61B2017/00438—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping connectable to a finger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00876—Material properties magnetic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
- A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B2017/320004—Surgical cutting instruments abrasive
- A61B2017/320008—Scrapers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00595—Cauterization
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2217/00—General characteristics of surgical instruments
- A61B2217/002—Auxiliary appliance
- A61B2217/005—Auxiliary appliance with suction drainage system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2217/00—General characteristics of surgical instruments
- A61B2217/002—Auxiliary appliance
- A61B2217/007—Auxiliary appliance with irrigation system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
Definitions
- the method also includes applying a coating precursor over the appendage-shaped portion of the former prior to producing the loader former. In some embodiments, the method includes removing the glove from the former by turning the glove inside-out.
- the surgical system 10 can also include a surgical gown 30 that includes a support system comprising first and second support conduits 34 for coupling to the first and second conduits 15 of the surgical glove 12 , respectively.
- the first and second support conduits 15 can be attached to the first sleeve of the gown 30 and can terminate is support connectors 149 .
- the first actuating element 200 , the first switch 48 , 448 , or both comprise a magnet. In some embodiments, the first actuating element 200 comprises a magnet.
- the former 710 can also include one or more discrete element magnetic positioning systems (e.g., 280 , 282 , 284 , 286 , 288 , 290 ).
- a heat shield magnetic positioning element 780 can be positioned at a distal end of an index finger of the former 710 .
- the heat shield magnetic positioning element 780 can overlap with a portion of the cutting device magnetic positioning element 718 of the cutting system magnetic positioning system 864 .
- the heat shield magnetic positioning element 780 and the cutting device magnetic positioning element 718 can be the same magnetic positioning element.
- discrete element magnetic positioning elements 780 , 782 and 784 are only shown in FIGS. 14A and 14B .
- interference fit is intended to refer to a seal that is fluid tight with respect to the coating precursor.
- former-side portions of features of a surgical system that form an interference fit with the former 210 will not be coated during the forming process and will be exposed (i.e., uncoated) once the glove 12 is removed from the former 210 .
- the loaded former 210 is dipped in the coating precursor, all other portions of the surgical system 14 will be surrounded by (i.e., embedded within) the glove material.
- FIG. 5A shows a cross-section of the relative positioning of the cutting switch 56 and cutting switch receiving portion 256 , where the cutting switch 56 is a depression actuated switch.
- the cutting switch 56 can include a base 156 and a switch (e.g., button) 157 extending from the base 156 , where the base 156 is wider than the switch 157 .
- the cutting switch receiving portion 256 can be tiered to include a base receiving portion 356 and a switch receiving portion 357 that extends deeper into the former 210 than the base receiving portion 356 .
Abstract
A proximity switch system that includes a self-contained power consuming device and a power source in electrical communication with the power consuming element across a magnetic proximity switch is disclosed. The proximity switch system includes an external magnet removably coupled to the magnetic proximity switch. A method of storing and/or transporting a proximity switch system is also disclosed. The method includes providing the proximity switch system and removably coupling an external magnet to the magnetic proximity switch in a position to prevent the magnetic proximity switch from inadvertently switching on.
Description
- This application is a continuation of U.S. patent application Ser. No. 15/151,151, filed May 10, 2016, which claims priority to U.S. Patent Application No. 62/331,203, filed May 3, 2016, and the '151 application is a continuation-in-part of U.S. patent application Ser. No. 14/988,464, filed Jan. 5, 2016, which is a continuation of U.S. patent application Ser. No. 13/626,771, filed Sep. 25, 2012, now U.S. Pat. No. 9,241,764, which claims priority to U.S. Provisional Patent Application No. 61/539,350, filed Sep. 26, 2011, the entireties of which are incorporated herein by reference.
- This invention is directed generally to a method of manufacturing surgical gloves including integral surgical systems for use by a surgeon during surgery.
- U.S. Pat. Nos. 7,931,648, 7,951,145 and 8,182,479 to Schneider (“Schneider patents”) disclosed surgical systems that include a glove with multiple surgical support systems attached thereto. Such gloves provide a number of advantages over conventional surgical systems where the gloves and surgical support systems (e.g., electrocautery, suction, irrigation, light, etc.) are not integrated. There are a wide variety of techniques useful for manufacturing conventional surgical gloves, which allow for high volume production of surgical gloves that meet stringent regulatory standards. However, these techniques are not sufficient for manufacturing the multi-functional surgical gloves described in the Schneider patents, as they do not allow for the integral inclusion of embedded surgical support systems or other elements at the time of glove formation. Adapting commercial products to include surgical support systems would require post-formation processes that would not be cost effective and could compromise the gloves barrier properties. Therefore, there is a need for improvement in the techniques available in order to make and manufacture the surgical systems described in the Schneider patents in a consistent, commercially reliable and cost-effective manner that will not compromise the surgical glove's material integrity or its ability to meet the required regulatory standards.
- This invention relates to a method of making polymeric gloves, including surgical gloves or other industrial gloves, that contain embedded functional components. The method of making can include providing a first functional component and providing a former comprising an appendage-shaped portion, where the former comprising a first magnetic positioning system. The method can also include producing a loader former by coupling the first functional component to an outer surface of the former using the first magnetic positioning system; and applying a polymer coating over the appendage-shaped portion of the loaded former to form a glove, where at least a portion of the first functional component is embedded within the glove.
- In some embodiments, the first magnetic positioning system includes at least one first magnetic positioning element. In some embodiments, the at least one first magnetic positioning element is embedded within the former. In some embodiments, the former is hollow and the at least one first magnetic positioning element is attached to an interior surface of the former. In some embodiments, the at least one first magnetic positioning element is attached to an exterior surface of the former.
- In some embodiments, the applying step includes dipping the loaded former into a pool of coating precursor. In some such embodiments, the applying step comprises stabilizing the coating precursor to form the polymer coating.
- In some embodiments, the method also includes applying a coating precursor over the appendage-shaped portion of the former prior to producing the loader former. In some embodiments, the method includes removing the glove from the former by turning the glove inside-out.
- In some embodiments, the first functional component is a first surgical system that includes a first surgical instrument and a first switch for controlling the first surgical system, and the glove is a surgical glove. In some such embodiments, the first magnetic positioning system comprises a first surgical instrument positioning element adapted to couple the first surgical instrument to the former and a first switch positioning element adapted to couple the first switch to the former.
- In some embodiments, a portion of the first functional component is embedded within the glove and another portion of the first functional component is exposed. In some such embodiments, the first functional component is a first surgical system comprising a first surgical instrument and a first switch for controlling the first surgical system, and the exposed portion comprises a portion of the first surgical instrument, a portion of the first switch, or both.
- In some embodiments, the method also includes providing a second functional component, and the former includes a second magnetic positioning system. In some such embodiments, the producing step comprises coupling the second functional component to an outer surface of the former using the second magnetic positioning system.
- In some such embodiments, the first magnetic positioning system comprises a first surgical instrument positioning element and a first switch positioning element, and the second magnetic positioning system comprises a second surgical instrument positioning element and a second switch positioning element. In some such embodiments, a portion of the first functional component is embedded within the glove and another portion of the first functional component is exposed, and a portion of the second functional component is embedded within the glove and another portion of the second functional component is exposed. In some such embodiments, the exposed portion of the first functional component is a portion of a first surgical instrument, a portion of a first switch, or both, and the exposed portion of the second functional component comprises a portion of a second surgical instrument, a portion of a second switch, or both.
- In some embodiments, the first functional component is a first discrete element. In some embodiments, the first magnetic positioning system comprises at least one first discrete element magnetic positioning element.
- In some embodiments, the at least one first discrete element magnetic positioning element is embedded within the former. In some embodiments, the former is hollow and the at least one first magnetic positioning element is attached to an interior surface of the former. In some embodiments, the at least one first discrete element magnetic positioning element is attached to an exterior surface of the former. In some embodiments, the first discrete element is embedded in a distal portion of the glove.
- Another embodiment described herein is a method of making a polymeric glove. The method can include providing a first functional component; providing a former comprising an appendage-shaped portion; applying a first coating precursor layer over the appendage-shaped portion of the former to form a first glove layer; loading the first functional component over the first glove layer to produce a loaded former; applying a second coating precursor layer over the appendage-shaped portion of the loaded former to form a second glove layer, and removing the polymeric glove from the former. The first functional component can be selected from a first discrete element and a first component system coupled to a first conduit. The polymeric glove can include the first and second glove layers, and at least a portion of the first functional component can be embedded within the polymeric glove.
- In some embodiments, the first glove layer is stabilized prior to the loading step.
- In some embodiments, the first glove layer is stabilized after the second coating precursor layer is applied but before the removing step.
- In some embodiments, the method includes applying a third coating precursor layer over the appendage-shaped portion of the loaded former, including the second glove layer, to form a third glove layer. In some embodiments, the second glove layer is stabilized prior to applying the third coating precursor layer. In some embodiments, the second glove layer is stabilized after the third coating precursor layer is applied but before the removing step.
- In another embodiment, a proximity switch system is described. The proximity switch system can include a self-contained power consuming device, comprising a power source in electrical communication with a power consuming element across a magnetic proximity switch; and an external magnet removably coupled to the magnetic proximity switch. In some embodiments, the external magnet is positioned to prevent the magnetic proximity switch from switching on when the device is not in use. In some embodiments, the power source is a battery.
- In some embodiments, the power consuming element is a light source. In some embodiments, the external magnet is coupled to the magnetic proximity switch using tape, the magnetism of an internal magnet contained within the proximity switch, a clip, or a combination thereof.
- In yet another embodiment, a method of storing and/or transporting a proximity switch system is described. The method can include providing a self-contained power consuming device, comprising a power source in electrical communication with a power consuming element across a magnetic proximity switch; and removably coupling an external magnet to the magnetic proximity switch in a position to prevent the magnetic proximity switch from inadvertently switching on. In some embodiments, the method includes shipping the self-contained power consuming device to a remote location.
- These and other embodiments are described in more detail below.
- The accompanying drawings, which are incorporated in and form a part of the specification, illustrate embodiments of the presently disclosed invention and, together with the description, disclose the principles of the invention.
-
FIG. 1A is a volar view of a former for a surgical glove as described herein; -
FIG. 1B is a volar view of the same former loaded with surgical systems, whileFIG. 1C is a volar view of the same former loaded with both surgical instruments and discrete elements. -
FIG. 2A is a dorsal view of the former ofFIG. 1 , andFIG. 2B is a dorsal view of the same former loaded with surgical systems and discrete elements. -
FIG. 3A is a side view of the former ofFIG. 1 , andFIG. 3B is a side view of the same former loaded with surgical systems. -
FIG. 4A is an end view of the former ofFIG. 1 ,FIG. 4B is an end view of the same former loaded with surgical systems, andFIG. 4C is an end view of the same former loaded with both surgical instruments and discrete elements. -
FIG. 5A is a cross-sectional view of an interference fit with the cutting switch taken along cutline 5A-5A ofFIG. 3B , andFIG. 5B is a cross-sectional view of an interference fit with the suction control port taken along cutline 5B-5B ofFIG. 3B . -
FIG. 6A is a dorsal view of a surgical system as described herein, including a right-handed glove and a shunt coupled to a sleeve of a surgical gown, andFIG. 6B is a dorsal view of a surgical system that includes a static switch and a magnetic discrete element for actuating the switch as described herein. -
FIG. 7 is a dorsal view of a surgical system as described herein, including a right-handed glove with a shunt coupled thereto. -
FIG. 8A is a volar view of the surgical system shown inFIGS. 6A and 7 andFIG. 8B is a volar view of the surgical system shown inFIG. 6B . -
FIG. 9A is a volar view of a former for making a polymeric glove with discrete elements as described herein, andFIG. 9B is a volar view of the same former loaded with discrete elements. -
FIG. 10 is a volar view of a glove produced using the former ofFIG. 9 . -
FIG. 11A is a volar view of a former for making a polymeric glove with discrete elements and component systems as described herein, andFIG. 11B is a volar view of the same former loaded with discrete elements and component systems. -
FIG. 12 is a volar view of a glove produced using the former ofFIG. 11 . -
FIG. 13 is a schematic of a proximity switch system with an external magnet attached thereto is described herein. -
FIG. 14A is a volar view of a former for a surgical glove as described herein, andFIG. 14B is a volar view of the same former loaded with both surgical instruments and discrete elements. -
FIG. 15A is a dorsal view of the former ofFIG. 14 , andFIG. 15B is a dorsal view of the same former loaded with surgical systems and discrete elements. -
FIG. 16A is a cross-sectional view of one arrangement of a magnetic positioning element incorporated into a former as described herein;FIG. 16B is another cross-sectional view of one arrangement of a magnetic positioning element incorporated into a former as described herein;FIG. 16C is yet another cross-sectional view of one arrangement of a magnetic positioning element incorporated into a former as described herein;FIG. 16D is still another cross-sectional view of one arrangement of a magnetic positioning element incorporated into a former as described herein; andFIG. 16E is a cross-sectional view of an arrangement of a magnetic positioning element and a depression incorporated into a former as described herein. - A method of making polymeric gloves with component systems, discrete elements, or both, embedded therein is described. The method can be used to completely or partially embed any of a variety of functional components (e.g., component systems, discrete elements) into a polymeric glove. The method of making polymeric gloves can be used to produce a wide variety of gloves including, but not limited to, surgical gloves, cleaning gloves, industrial gloves, and prophylactics. As used herein, “glove” is intended to have its conventional meaning and also include condoms, which can be made using the techniques described herein. Similarly, “appendage-shaped” is intended to include both hand-shaped and phallus-shaped objects.
- As shown in the Figures, a method of making a polymeric glove can include providing a first functional component. The first functional component can be selected from a first discrete element and a first component system coupled to a first conduit. The method can also include providing a former comprising an appendage-shaped portion, where the former includes a first depression for receiving the first functional component. The method can include loading the first functional component into the first depression, and applying a polymer coating over the loaded former to form a polymeric glove. As described with respect to surgical gloves below, depending on the desired properties and configuration, the applying step can occur after the loading step or the applying step can occur both before and after the loading step.
- As used herein, “functional component” is intended to include both component systems and discrete elements. As used herein, “component systems” include surgical and non-surgical functional components that includes a support conduit for physically connecting to a source (e.g., power source, suction source, irrigation source, etc.) external to the glove. Exemplary component systems include, but are not limited to,
light sources 16, cuttingsources 18, suction/vacuum sources - As used herein, “discrete element” refers to a functional component that does not include a conduit for physically connecting to a source external to the glove. Discrete elements must be adapted to functionally enhance the glove and do not include fillers or debris embedded within the material forming the glove. A discrete element could be non-physically connected to an external source, such as via a wireless connection, and could include an internal battery as a power supply. Exemplary discrete elements include, but are not limited to, insulating materials (e.g., heat shield), reinforcing elements, battery operated light sources, temperature strips, reflective elements, resistance thermometers, brushes and other cleaning implements, gripping and friction enhancing elements, and detection strips (e.g., pH, bacteria, toxin, etc.).
- The first depression can be adapted to produce an interference fit with at least a portion of a first functional component. A portion of the first functional component can be embedded within the polymeric glove and another portion of the first functional component can be exposed.
- The first functional component can be a first discrete element. The first discrete element—and any other discrete element described herein—can be a discrete element selected from the group consisting of insulating materials (e.g., heat shield), reinforcing elements, battery operated light sources, temperature strips, reflective elements, resistance thermometers, brushes and other cleaning implements, gripping and friction enhancing elements, and detection strips (e.g., pH, bacteria, toxin, etc.).
- The first functional component can be a first component system comprising a first active end and a first conduit, and the first depression can include a first active end receiving portion and a first conduit receiving portion. In such methods, the loading step can include loading the first active end into the first active end receiving portion and the first conduit into the first conduit receiving portion.
- The method can also include providing a second functional component. The second functional component can be selected from a second discrete element and a second component system coupled to a second conduit. The former can include a second depression for receiving a second functional component. The method can include loading the second functional component into the second depression. The first and second function components can be different or the same.
- The method can be performed using at least two functional components, at least three functional components, at least four functional components, at least five functional components or more. Any combination of discrete elements and component systems can be used in the method.
- As shown in
FIG. 9 , the former 210 can be adapted for producing a cleaning glove 512.FIG. 9A shows the former 210 in the unloaded state, whileFIG. 9B shows the former 210 loaded with thediscrete elements - In such a method, the former 210 can include discrete
element receiving portions 410 at the distal, volar portion of thethumb 412 and each of thefingers element receiving portions 410 at the distal, volar portions of thethumb 412,index finger 414,long finger 416 andring finger 418, respectively, can each be adapted to receive scrubbingelements 522. Exemplary scrubbing elements 422 include, but are not limited to brushes, raised surfaces, undulating surfaces, and nubbed surfaces. The scrubbingsurface 524 of the scrubbingelements 522 may be embedded in or protruding from the resulting glove 510, shown inFIG. 10 . - The discrete
element receiving portion 420 at the distal, volar portion of the little finger can be adapted to receive a detectingelement 526, such as, a bacteria tester. The detecting element can be used to test for certain types of bacteria while the user is wearing the glove 512 formed using the former 210. Thedetection surface 528 can be embedded in or protruding from the glove 512 shown inFIG. 10 . As will be understood, when it is desired for thediscrete element element receiving portions 410 can form an interference fit with thediscrete element - As shown in
FIG. 10 , the glove 512 can include scrubbingelements 522 at the distal, volar portions of the thumb, index finger, long finger and ring finger, and a detectingelement 526 at the distal, volar portion of the little finger. In some gloves 512, for example when the scrubbingelements 522 are undulated surfaces, the scrubbingelements 522 can also facilitate gripping of objects. During the cleaning process, the user can monitor the detectingelement 526 to determine if any undesirable bacteria or toxins are present. The detectingelement 526 can be adapted to change appearance (e.g., color) if a target bacteria or toxin is present. -
FIG. 11 shows a former 210 for producing thesuction glove 552 shown inFIG. 12 . Thesuction glove 552 can be adapted for handling delicate objects without introducing oils from the hand. For example, thesuction glove 552 can be used to transport wafers or other objects in clean rooms. - As shown in
FIG. 12 , theglove 552 can include component systems comprising avacuum cone 554 attached to distal, volar portions of the index finger, long finger and ring finger of the glove. Each of thevacuum cones 554 can be coupled tovacuum conduits 556 that extend along a radial aspect of the finger to which eachvacuum cone 554 is attached and then over onto the dorsal aspect of the metacarpal of that finger before terminating at an interconnect in a manner analogous to thevacuum conduit 60 shown inFIG. 6 . The vacuum conduits 4556 can be coupled to thevacuum cones 554 proximate an apex of thevacuum cones 554. Thevacuum conduit 556 can also extend along an ulnar aspect of the finger to which it is attached in a manner analogous, but opposite, to that shown inFIG. 12 . Theglove 552 can also include agripping element 530 on a volar surface of the thumb of theglove 552. - The
inner surface 558 of thevacuum cone 554 can be protruding from theglove 552 and free from a coating of the polymer forming the body of the glove 552 (i.e., theinner surface 558 can be exposed). Similarly, thegripping surface 532 of thegripping element 530 can be exposed and/or protruding from theglove 552. As will be understood, when it is desired for a portion of thefunctional components portions functional components -
FIG. 11A shows the former 210 in the unloaded state, whileFIG. 11B shows the former 210 loaded with thevacuum systems gripping element 530. The vacuumcone receiving portions 454 are located at distal, volar portions of the index finger, long finger and ring fingers of the former 210. Vacuumconduit receiving portions 456 extend from the vacuumcone receiving portions 454 to a radial aspect of the finger on which each vacuumcone receiving portion 454 is located and then over onto a dorsal aspect of the metacarpal of that finger before terminating. The vacuumconduit receiving portion 456 can terminate in an interconnect receiving portion in a manner analogous to the suctionconduit receiving portion 260 as shown inFIG. 2A . The thumb of the former 210 can also include a discreteelement receiving portion 412, which can be loaded with agripping element 530. Thegripping element 530 can be useful for separating the component (e.g., a silicon wafer) being handled using the glove from thevacuum cones 554. - As a specific application of the method of making polymeric gloves, a method of making surgical gloves with surgical support systems embedded therein is also described. Although the following discussion is directed toward surgical gloves, surgical support systems, and surgical discrete elements, it should be understood that the techniques described herein can be used to embed any type of functional element into any polymeric glove or similar device. It should also be noted that the phrases “support system” and “component system” are used interchangeably herein.
- The method can include providing an hand-shaped former 210 with a plurality of depressions, as shown in
FIGS. 1A, 2A, 3A & 4A , and loading the depressions with corresponding surgical systems. A coating or layer can be formed over and around the surgical systems by dipping the loaded former into a coating precursor solution one or more times. The method can include dipping the former into more than one coating precursor solution. The method can also include dipping the former into one or more coating precursor solutions—and, optionally, allowing the coating precursor to cure—prior to loading the former. - Another embodiment described herein is a method of making a polymeric glove. The method can include providing a first functional component; providing a former comprising an appendage-shaped portion; applying a first coating precursor layer over the appendage-shaped portion of the former to form a first glove layer; loading the first functional component over the first glove layer to produce a loaded former; applying a second coating precursor layer over the appendage-shaped portion of the loaded former to form a second glove layer, and removing the polymeric glove from the former. The first functional component can be selected from a first discrete element and a first component system coupled to a first conduit. The polymeric glove can include the first and second glove layers, and at least a portion of the first functional component can be embedded within the polymeric glove.
- In some embodiments, the first glove layer is stabilized prior to the loading step. In some embodiments, the first glove layer is stabilized after the second coating precursor layer is applied but before the removing step.
- In some embodiments, the method includes applying a third coating precursor layer over the appendage-shaped portion of the loaded former, including the second glove layer, to form a third glove layer. In some embodiments, the second glove layer is stabilized prior to applying the third coating precursor layer. In some embodiments, the second glove layer is stabilized after the third coating precursor layer is applied but before the removing step.
- Prior to describing the method in more detail, exemplary gloves that can be made using the method will be described. The method described herein can be used to produce the gloves described in U.S. Pat. Nos. 7,931,648, 7,951,145 and 8,182,479 to Schneider, and U.S. patent application Ser. No. 13/626,733, entitled “Surgical Glove System and Methods of Using the Same,” filed Sep. 25, 2012, the entirety of which is incorporated herein by reference.
- As shown in
FIGS. 6A-8B , thesurgical system 10 can include asurgical glove 12 configured to be removably attached to a human hand. Theglove 12 can include first and secondsurgical systems 14 attached to theglove 12, wherein the firstsurgical system 14 comprises a firstsurgical instrument 17 and afirst conduit 15, and the secondsurgical system 14 comprises a secondsurgical instrument 17 and asecond conduit 15. Each of the first and secondsurgical systems 14 can be attached to an index finger, a long finger or a little finger of thesurgical glove 12. Similarly, as shown in the Figures, the thumb and the ring finger of thesurgical glove 12 can be free of allsurgical systems 14. - The
surgical systems 14 can also include a first and a second switch (e.g., 48, 56, 58, 62, 64, 70 and 140) attached to theglove 12 for controlling the first and secondsurgical systems 14, respectively. The first and second switches (e.g., 48, 56, 58, 62, 64, 70 and 140) can be attached to a finger of theglove 12 to which the first and secondsurgical systems 14 are attached, respectively. The first and second switches (e.g., 48, 56, 58, 62, 64, 70 and 140) can be operable by a thumb of a human hand wearing theglove 12. - The
surgical systems 14 can also include (i) asafety switch 140 attached to theglove 12 for controlling the firstsurgical system 14 so that said firstsurgical system 14 will not operate unless both said first switch (e.g., 56 or 58) and thesafety switch 140 are actuated simultaneously, or (ii) ashunt 142 for controlling fluid flow between said first and second conduits (e.g., 60 and 68). In some cases, thesurgical system 14 can include one or more additionalsurgical systems 14 and can include both asafety switch 140 and ashunt 142. - The
surgical system 10 can also include a surgical gown 30 that includes a support system comprising first and second support conduits 34 for coupling to the first andsecond conduits 15 of thesurgical glove 12, respectively. The first andsecond support conduits 15 can be attached to the first sleeve of the gown 30 and can terminate issupport connectors 149. - The first and second
surgical systems 14 can include at least oneirrigation port 22 and at least onesuction port 20, respectively. Thesurgical system 10 can include ashunt 142 for controlling fluid flow between theirrigation conduit 68 and thesuction conduit 60. Theshunt 142 can be used to direct the flow of fluid from theirrigation conduit 68 to thesuction conduit 60. Theshunt 142 can also be used to direct the flow of fluid toward thesuction port 22, away from thesuction port 22, or both, either simultaneously or alternately. This can be particularly useful for clearing debris, such as tissue, from the suction system (22, 68 & 69). - The
shunt 142 can include first and second T-valves irrigation conduit 68 and thesuction conduit 60, respectively. The first T-valve 144 can be in fluid communication with the second T-valve 146. As shown inFIG. 6 , a first portion of the shunt (e.g., 144) can be in-line with theirrigation support conduit 69 and a second portion of the shunt (e.g., 146) can be in-line with thesuction support conduit 61. Alternately, as shown inFIG. 7 , a first portion of the shunt (e.g., 144) can be in-line with theirrigation conduit 68 and a second portion of the shunt (e.g., 146) can be in-line with thesuction conduit 60. - As shown in
FIGS. 6A-8B , thesurgical glove 12 can includelight sources 16, anelectrocautery device 18, asuction port 20, and anirrigation port 22 coupled to the same glove. Afirst light source 16 can be located on a distal portion of an index finger and alight conduit 42 can run along an ulnar portion of the index finger onto adorsal portion 150 of the metacarpals (e.g., between the second and third metacarpals). A secondlight source 16 can be located on a distal portion of a long finger and alight conduit 42 can run along an ulnar portion of the long finger onto adorsal portion 150 of the metacarpals (e.g., between the third and fourth metacarpals). The first and second light source control switches 48 can be attached to an ulnar portion of the finger of the glove to which the first and secondlight sources 16, respectively, are attached. -
FIGS. 6B and 8B show embodiments of the surgical system that include a surgical glove with a self-containedpower consuming device 402, comprising apower source 202 in electrical communication with apower consuming element 16 across amagnetic proximity switch 448. InFIGS. 6B and 8B , thefirst switch 48 is actuated due to the proximity of anactuating element 200, which can be adiscrete element 84. In such embodiments, theswitch - The proximity switch can be a latching switch or a non-latching switch. A latching switch will switch-on and stay on once it is actuated by the
actuating element 200 even after theactuating element 200 is removed from the general vicinity of the switch. The latching switch will switch-off when theactuating element 200 is again brought close enough to the switch to release the latch. A non-latching proximity switch will remain on when theactuating element 200 is adjacent the switch, but will turn off when theactuating element 200 is no longer proximate to the switch. - As shown in
FIGS. 6B and 8B , in some embodiments, thesurgical system 10 can include asurgical glove 12 configured to be removably attached to a human hand. Thesurgical glove 12 can include a firstsurgical instrument 17 attached to thesurgical glove 12, where the firstsurgical instrument 17 is nonremoveably, integrally attached to thesurgical glove 12 during the formation of thesurgical glove 12, and the firstsurgical instrument 17 is coupled to a finger of the surgical glove. In some embodiments, as shown inFIGS. 6B and 8B , thesurgical glove 12 can also include afirst switch surgical support system 17, and afirst actuating element 200 attached to a thumb of thesurgical glove 12. Thefirst actuating element 200 can be a discrete element. In some embodiments, thefirst switch first actuating element 200 is placed in close proximity to thefirst switch - In some embodiments, the
first actuating element 200, thefirst switch first actuating element 200 comprises a magnet. - In some embodiment, the first
surgical support system 17 can be alight source 16. In some embodiments, as shown inFIGS. 6B and 8B , the self-containedpower consuming device 402 can be a firstsurgical instrument 17 that includes an LED light source. In some embodiments, as shown inFIG. 6B , the self-containedpower consuming device 402 is a discrete element that includes alight source 16, aswitch 448, and apower supply 202. Although shown as a separate component, it will be understood that thepower supply 202 andlight source 16 can be combined into a single housing. - In some embodiments, the
light source 16 can be an electroluminescent system. For example, the light source can include an electroluminescent material and electrodes arranged to cause the electroluminescent material to emit visible light by applying an electrical differential across the electroluminescent material. In some embodiments, the electroluminescent material can be sandwiched between layers of the glove. In other embodiments, the electroluminescent material can be applied to an inner or outer surface of the glove. As will be understood, the electroluminescent material can replace any of the light sources (e.g., LEDs) shown and described herein. - During development of the gloves described herein, it was determined that static switches can accidentally be triggered when the self-contained
power consuming device 402 is being transported. This issue may be particularly pronounced for latching, static switches, and where, as here, the proximity switch is part of a self-containedpower consuming device 402 that is embedded in the glove (i.e., the product must be shipped with thepower source 202 connected to the power consuming element 404. It has been determined that this can be prevented using aproximity switch system 600 as described herein. - As shown in
FIG. 13 , theproximity switch system 600 can include a self-containedpower consuming device 402, comprising apower source 202 in electrical communication with a power consuming element 404 across amagnetic proximity switch 448; and anexternal magnet 406 removably coupled to themagnetic proximity switch 448. In some embodiments, theexternal magnet 406 is positioned to prevent themagnetic proximity switch 448 from switching on when thedevice 402 is not in use. In some embodiments, the power source is a battery. - In some embodiments, the power consuming element 404 is a
light source 16. In some embodiments, theexternal magnet 406 is coupled to themagnetic proximity switch 448 using tape, the magnetism of an internal magnet 408 contained within theproximity switch 448, a clip, or a combination thereof. - In yet another embodiment, a method of storing and/or transporting a
proximity switch system 600 is described. The method can include providing a self-containedpower consuming device 402, comprising apower source 202 in electrical communication with a power consuming element 404 across amagnetic proximity switch 448; and removably coupling anexternal magnet 406 to themagnetic proximity switch 448 in a position to prevent themagnetic proximity switch 448 from inadvertently switching on. In some embodiments, the method includes shipping the self-containedpower consuming device 600 to a remote location. - As shown in
FIGS. 6A-8B , anelectrocautery device 18 can be coupled to a distal or distal, volar 152 portion of the index finger. Theelectrocautery conduit 52 can run from theelectrocautery device 18 along a radial portion of the index finger and then onto adorsal portion 150 of the metacarpals (e.g., along a radial-dorsal portion of a second metacarpal). A cuttingswitch 56 and a coagulatingswitch 58 can be coupled to theelectrocautery conduit 52 and positioned along a radial surface of the index finger such that the cutting and coagulatingswitches surgical glove 12. As used herein, “electrocautery device” is used broadly and is intended to include cutting sources such as electrical cautery sources, ultrasonic cutting surgical devices, and ultrasonic coagulating surgical devices. - As shown in
FIGS. 8A and 8B , aheat shield 80 can be coupled to the glove and positioned between the user's hand and theelectrocautery tip 18. This positioning can be adapted to prevent injury to the user and damage to the glove. Theheat shield 80 can be separate from, or coupled to, theelectrocautery tip 18. - As shown in
FIG. 7 , asafety switch 140 can be coupled to theelectrocautery conduit 52 and positioned such that none of the fingers of the hand wearing thesurgical glove 12 can actuate thesafety switch 140. For example, thesafety switch 140 can be positioned along adorsal aspect 150 of theglove 12 covering the metacarpals of a hand wearing the glove. As shown inFIG. 7 , thesafety switch 140 can be attached to thesurgical glove 12 proximate a dorso-radial aspect of a second metacarpal of a human hand wearing thesurgical glove 12. - The electrocautery system can be designed such that the
electrocautery device 18 cannot be activated unless both thesafety switch 140 and the appropriate switch (56 or 58, respectively) are actuated simultaneously. Because of the positioning of thesafety switch 140, activation of theelectrocautery device 18 requires two hands and the potential for injury to the patient, the surgeon or other operating room personnel is greatly reduced or eliminated. - As shown in
FIGS. 6A-8B , asuction port 20 can be coupled to a distal or distal, radial portion of the long finger. Thesuction conduit 60 can run from thesuction port 20 along a radial aspect of the long finger and then onto adorsal portion 150 of the metacarpals (e.g., along a dorsal portion between the second and third metacarpals). A suctionport control switch 62 and asuction control port 64 can be provided along thesuction conduit 60. The suctionport control switch 62 and thesuction control port 64 can be positioned along a radial surface of the long finger such that the suctionport control switch 62 and thesuction control port 64 can be actuated by a thumb of the hand to which thesurgical glove 12 is attached. - As shown in
FIGS. 6A-8B , anirrigation port 22 can be coupled to a distal or distal, radial portion of the little finger. Theirrigation conduit 68 can run from theirrigation port 22 along a radial portion of the little finger and then onto adorsal portion 150 of the metacarpals (e.g., along a dorsal portion on the radial or ulnar side of the fifth metacarpal). Anirrigation control switch 70 can be provided along theirrigation conduit 68. Theirrigation control switch 70 can be positioned along a radial surface of the little finger such that theirrigation control switch 70 can be actuated by a thumb of the hand to which thesurgical glove 12 is attached. - Each of the conduits (42, 52, 60 and 68) can include a
terminal interconnect 148 as a proximal end of the conduit. As shown inFIGS. 6 and 7 , each of the terminal interconnects 148 can correspond to asupport interconnect 149 located as a distal end of a corresponding support conduit (43, 53, 61 and 69). As shown inFIG. 7 , the conduits (42, 52, 60 and 68) can terminate in a combinedterminal interconnect 148 and the support conduits (43, 53, 61 and 69) can terminate in a combinedsupport interconnect 149. The terminal interconnect(s) 148 can be a male or female interconnect and the support interconnect(s) 149 can be a complementary female or male interconnect. - Each of the conduits (42, 52, 60 and 68) can traverse a mid-coronal plane of a finger of the
surgical glove 12. Similarly, each of the conduits (42, 52, 60 and 68) can follow a linear isometric path along a finger of the glove. This is of great benefit as it allows the manufacture of a snug fitting surgical glove with the conduits embedded therein. If, as in the prior art, the conduits are positioned along volar or dorsal surfaces of the glove, it is not possible to obtain the desired fit without increasing the risk of separation of the conduit from the glove. - Although
FIGS. 6A-8B are depicted with respect to a right-handed glove, it should be understood that any of the descriptions provided herein can apply equally to the left hand. To facilitate the description of left-handed gloves, the positioning of all aspects of the surgical system have been provided such that they are spatially unambiguous regardless of whether they refer to a right-handed glove or a left-handed glove. Of course, any and all of the surgical systems described herein can be attached to a right-handed glove or a left-handed glove. In some instances, the surgical system can include both a right-handed glove and a left-handed glove. - As shown in
FIGS. 6A-8B , the surgical glove can also include additional discrete elements. The additional discrete elements can be embedded in the surgical glove. As will be understood, discrete elements generally refer to devices or objects attached to (embedded in) the surgical glove that do not include a conduit terminating in a terminal interconnect 148 (e.g., does not require a support conduit). Exemplary, discrete elements include, but are not limited to, a heat shield, a reinforcing element, a battery operated light source, a temperature strip, a reflective element, and a resistance thermometer. -
FIGS. 6A-8B show reinforcing elements - In addition,
discrete element 84 is positioned on a distal, volar portion of the long finger. Thisdiscrete element 84 can provide a reinforcing function or can provide an independent function, such as being a resistance thermometer, a reflector, or a temperature strip. -
Reflective elements light sources 16. As shown inFIGS. 6A-8B , thereflective elements reflective elements light sources 16 in a volar, distal direction. This enables the user to better illuminate the target, e.g., surgical field. Eachreflective element light source 16. Thereflective elements - It should be noted that, because the discrete elements (e.g., 80, 82, 84, 86, 88 & 90) can be thin, uniform sheets, the discrete elements can be included on any portion of the hand or any of the fingers, including the thumb and/or ring finger, without interfering with the surgeon's ability to manipulate surgical clamps or other surgical devices while wearing the surgical gloves. Alternately, the thumb and/or ring finger of the gloves can be free of both surgical systems and discrete elements.
- Having described exemplary surgical gloves that can be made using the method described herein, a method of making surgical gloves such as those shown in
FIGS. 6A-8B is disclosed.FIGS. 14-16 depict a former 710 that can be used to make a glove that is the mirror image of the glove shown inFIGS. 6-8 .FIG. 14A shows various perspectives of the former 710 and the position of the magnetic positioning systems 714 therein, whileFIG. 14B show the volar perspective of the former 710 loaded with bothsurgical systems 14 and discrete elements. -
FIGS. 14A and 14B show various views of a former 710 used to form a left-handed glove. The former 710 can include a suctionsystem positioning system 860. As shown in the volar view ofFIG. 14B , the suction systemmagnetic positioning system 860 can include one or more of a suction devicemagnetic positioning element 720, a suction port control switchmagnetic positioning element 762, a suction control portmagnetic positioning element 764, and a suction conduitmagnetic positioning element 760. As shown inFIG. 15A , the suction systemmagnetic positioning system 860 can include a terminal connectormagnetic positioning element 848 proximate a wrist portion of the former 710. The suction systemmagnetic positioning system 860 can start proximate a distal end of the long finger and extend along volar aspects, radial aspects or volar-radial aspects of the long finger. As shown inFIGS. 15A and 15B , the suction systemmagnetic positioning system 860 can then continue to a dorsal side of the former 710 between the long finger and the index finger of the former and extend between or proximate the second and third metacarpals. - As will be understood, some of the magnetic positioning elements described herein may not be necessary to achieve adequate coupling of the functional component to the former. This can be helpful, particularly in cases where the particular component of the functional component is not magnetic. For example, some of the conduits may be formed of a plastic material, rather than a ferromagnetic metal, while other elements of the functional component may include ferromagnetic metal. In those instances, there would be no need to include magnetic positioning elements to couple with the non-ferromagnetic elements of the functions component.
- The former 710 can also include an irrigation system
magnetic positioning system 862. As shown in the volar view ofFIGS. 14A and 14B , the irrigation systemmagnetic positioning system 862 can include one or more of an irrigation devicemagnetic positioning element 722, an irrigation control switchmagnetic positioning element 770, and an irrigation conduitmagnetic positioning element 768. As shown in the dorsal view ofFIGS. 15A and 15B , the irrigation systemmagnetic positioning system 862 can include a terminal connector receivingmagnetic positioning element 848 proximate a wrist portion of the former 710. The irrigation systemmagnetic positioning system 862 can start proximate a distal end of the little finger and extend along volar aspects, radial aspects or volar-radial aspects of the little finger. As shown inFIGS. 15A and 15B , the irrigation systemmagnetic positioning system 862 can then continue to a dorsal side of the former 710 between the ring finger and the little finger of the former and extend between or proximate the fourth and fifth metacarpals (e.g., along an ulnar portion of the fourth or fifth metacarpal). - The former 710 can also include a cutting system
magnetic positioning system 864. As shown in the volar view ofFIGS. 14A and 14B , the cutting systemmagnetic positioning system 864 can include at least one of a cutting devicemagnetic positioning element 718, a cutting switchmagnetic positioning element 756, a coagulation switchmagnetic positioning element 758, and a cutting conduitmagnetic positioning element 752. As shown in the dorsal view ofFIGS. 15A and 15B , the cutting systemmagnetic positioning system 864 can include a terminal connectormagnetic positioning element 848 proximate a wrist portion of the former 710. The cutting systemmagnetic positioning system 864 can start proximate a volar aspect of the distal end of the index finger and extend along radial aspects of the index finger. As shown inFIGS. 15A and 15B , the cutting systemmagnetic positioning system 864 can then continue to a dorsal side of the former 710 between the thumb and index finger of the former and extend between or proximate the first and second metacarpals (e.g., along a radial portion of the second metacarpal). - The former 710 can also include one or more light source system
magnetic positioning systems FIGS. 15A and 15B , the light source systemmagnetic positioning systems magnetic positioning elements 716, light source switchmagnetic positioning elements 748, and a light source conduitmagnetic positioning element 742. As shown in the dorsal view ofFIGS. 15A and 15B , the light source systemmagnetic positioning systems 864 can include a terminal connectormagnetic positioning element 848 proximate a wrist portion of the former 710. - The first light source system
magnetic positioning system 866 can start proximate a distal end of a dorsal or distal aspect of the long finger and extend to an ulnar aspects of the long finger. As shown inFIGS. 15A and 15B , the first light source systemmagnetic positioning system 866 can then continue to a dorsal side of the former 710 between the long finger and ring finger of the former and extend between or proximate the third and fourth metacarpals (e.g., along an ulnar portion of the third metacarpal). - Similarly, the second light source system
magnetic positioning system 868 can start proximate a distal end of a dorsal or distal aspect of the index finger and extend to an ulnar aspects of the index finger. As shown inFIGS. 15A and 15B , the second lightsource system depression 868 can then continue to a dorsal side of the former 710 between the index finger and long finger of the former and extend between or proximate the second and third metacarpals (e.g., along an ulnar portion of the second metacarpal). - The former 710 can also include one or more discrete element magnetic positioning systems (e.g., 280, 282, 284, 286, 288, 290). As shown in the volar view of
FIGS. 14A and 14B , a heat shieldmagnetic positioning element 780 can be positioned at a distal end of an index finger of the former 710. The heat shieldmagnetic positioning element 780 can overlap with a portion of the cutting devicemagnetic positioning element 718 of the cutting systemmagnetic positioning system 864. In some embodiments, the heat shieldmagnetic positioning element 780 and the cutting devicemagnetic positioning element 718 can be the same magnetic positioning element. In order to simplify the Figures, discrete elementmagnetic positioning elements FIGS. 14A and 14B . - The former 710 can include at least one reinforcing element
magnetic positioning element 782, 786. As shown inFIGS. 14A and 14B , a reinforcing elementmagnetic positioning element 782 can be positioned at a distal end of a volar aspect of the thumb of the former 710. As shown inFIGS. 15A and 15B , a reinforcing element magnetic positioning element 786 can be positioned at a distal end of a dorsal aspect of the thumb of the former 710. These locations of the thumb may be reinforced in order to reduce wear when these locations are used to actuate switches embedded in, or protruding from, the glove. As will be understood, reinforcing elements can be positioned on any portion of the former 710 where it would be desired to reinforce the glove, including any aspect of the fingers and the volar or dorsal metatarsal region of the hand. The reinforcing element magnetic positioning element(s) can be generally rectangular, or round, or any other appropriate shape corresponding to the area where reinforcement in desired. In order to simplify the Figures, reinforcingelements 782, 786 are only shown inFIGS. 14A /B and 15A/B, respectively. - The former 710 can include additional discrete element magnetic positioning elements, such as a
thermometer strip depression 784. The corresponding thermometer strip can visually indicate temperature for example by color. As shown inFIGS. 14A and B, athermometer strip depression 784 can be positioned at a distal end of a volar aspect of the long finger of the former 710. The thermometer stripmagnetic positioning element 784 can be generally rectangular, or round, or any other appropriate shape corresponding to the area where reinforcement in desired. In order to simplify the Figures, thermometer stripmagnetic positioning element 784 is only shown inFIGS. 14A and B. - The magnetic positioning elements can be incorporated into the former 710 using a variety of approaches. In some embodiments, as shown in
FIGS. 16B and 16C , the at least one first discrete element magnetic positioning element (e.g., 782) is embedded within the former 710. In some embodiments, as shown inFIGS. 16A and 16E , the former 710 is hollow and the at least one first magnetic positioning element (e.g., 782) is attached to an interior surface of the former 710. In some embodiments, as shown inFIG. 16D , the at least one first discrete element magnetic positioning element (e.g., 782) is attached to an exterior surface of the former 710. In some embodiments, the first discrete element is embedded in a distal portion (e.g., the tip of a finger) of the glove. Alternately, or in combination, as shown inFIGS. 1-4 , the method can include providing an hand-shaped former 210 with a plurality of depressions and loading the depressions with corresponding surgical systems. For example,FIG. 16E , shows an example of a combination of adepression 282 and amagnetic positioning element 782. A coating can be formed over and around the surgical systems by dipping the loaded former into a coating precursor solution one or more times. The method can include dipping the former in to more than one coating precursor solution.FIGS. 1-4 showexemplary formers 210 both with and withoutsurgical systems 14. It should be noted that the system can be mounted using magnets as described with respect toFIGS. 14-15 either with or without depressions. - As used herein, “depression” refers to an indentation for receiving a portion of a surgical system. Depressions—especially those for surgical systems—can include channel portions with generally U-shaped or V-shaped cross-sections having opposing sides that are generally parallel to one another. As used herein, “generally” refers to the general appearance of a cross-section or a minor deviation for a referenced orientation. For example, generally parallel sides deviate from parallel by ≤30°, or ≤20°, or ≤10, or The sides of the depressions 214 described herein can have generally parallel sides where they are designed to form an interference fit with a portion of a
surgical system 14. This helps enable the opposing sides of the former to for a liquid tight seal with the sides of the portion of thesurgical system 14. It should be observed that where the cross-section is taken through the center of a depression that is circular, elliptical or similarly shaped, the sides of that shape can be considered generally parallel. - The method can include providing a first
surgical system 14 comprising a firstsurgical instrument 17 and a first switch (e.g., 48, 56, 58, 62, 64, 70 & 140) for controlling the firstsurgical system 14. The method can include providing a former 210 comprising an hand-shaped portion 212. The former 210 can include a first depression 214 for receiving the firstsurgical system 14. The first depression 214 can be adapted to produce an interference fit with at least a portion of the firstsurgical system 14. The firstsurgical system 14 can be loaded into the first depression 214 and a polymer coating can be applied over the loaded former 210 to form asurgical glove 12. In addition to the hand-shaped portion, the former 210 can include a wrist portion and a proximal forearm portion. - The method can also include providing at least one discrete element (e.g., 80, 82, 84, 86) such as, but not limited to, a heat shield, a reinforcing material and a temperature indicating device. The former 210 can include at least one discrete element depression (e.g., 280, 282, 284, 288, 290) for receiving the at least one discrete element (e.g., 80, 82, 84, 86, 88, 90). The at least one discrete element depression (e.g., 280, 282, 284, 286, 288, 290) can be, but is not necessarily, adapted to produce an interference fit with at least a portion of the discrete element (e.g., 80, 82, 84, 86, 88, 90). The at least one discrete element can be loaded into the at least one discrete element depression (e.g., 280, 282, 284, 286, 288, 290) and a polymer coating can be applied over the loaded former 210 to form a
surgical glove 12 using the methods described herein. - The applying step can include dipping the loaded former 210 into a pool of coating precursor. The applying step can include dipping the loaded former 210 into a pool of coating precursor more than once. The applying step can include dipping the loaded former 210 into more than one pool of coating precursor. For example, the loaded former 210 can be dipped into a polymer precursor and then into a polymer stabilization pool (e.g., cross-linker, catalyst, initiator, etc.). The method can be continuous. The method can include heating the loaded former 210 prior to dipping in order to facilitate formation of a coating on the loaded former 210.
- Forming a layer or coating as described herein can include dipping the loaded or unloaded former into a polymer precursor one or more times.
- As used herein, “coating precursor” is intended to include a composition helpful for forming a stabilized coating. Exemplary coating precursors include, but are not limited to, polymer precursors (e.g., monomer solutions), polymer solutions (including, latex dispersion), catalysts, initiators, cross-linkers, coagulants, and mixtures thereof.
- As used herein, “interference fit” is intended to refer to a seal that is fluid tight with respect to the coating precursor. In other words, former-side portions of features of a surgical system that form an interference fit with the former 210 will not be coated during the forming process and will be exposed (i.e., uncoated) once the
glove 12 is removed from the former 210. In contrast, because the loaded former 210 is dipped in the coating precursor, all other portions of thesurgical system 14 will be surrounded by (i.e., embedded within) the glove material. - The first depression 214 can include a first surgical instrument receiving portion 217 and a first switch receiving portion (e.g., 248, 256, 258, 262, 264 & 270). The first
surgical system 14 can also include afirst conduit 15 and the first depression 214 can also include a first conduit receiving portion 215. The firstsurgical system 14 can also include aproximal interconnection 148 and the first depression 214 can also include a proximalinterconnection receiving portion 348. The interference fit can be formed with a portion of the firstsurgical instrument 17, a portion of the first switch (e.g., 48, 56, 58, 62, 64, 70 & 140), a portion of theproximal interconnection 148, or a combination thereof. In someformers 210, there will not be an interference fit between theconduit 15 and the first conduit receiving portion 215. - The method can also include removing the
surgical glove 12 from the former 210 by turning thesurgical glove 12 inside-out. A portion of the firstsurgical system 14 can be embedded within thesurgical glove 12 and a portion of the firstsurgical system 14 can be exposed (i.e., extend from the surgical glove 12). The exposed portion can include a portion of the first surgical instrument, a portion of the first switch, or both. The exposed portion can correspond to the former-side of the portion of the firstsurgical system 14 producing an interference fit with the first depression 214. - As will be understood, it may be particularly useful to have particular portions of the
surgical system 14 exposed. Portions that can be beneficial to expose include, but are not limited to,surgical instruments 17, switches (e.g., 48, 56, 58, 62, 64, 70 & 140), ports, andterminal interconnections 148. This may be particularly useful for providing access to switches and ports, as well as, for embodiments where the surgical instruments are removable. In such embodiments, the removable portion cab be attached to the glove after the forming process. In some methods, the former 210 may be dipped, fingers first, into the coating precursor pool to a depth such that the terminal interconnections do not contact the pool of coating precursor. - The method can also include providing a second
surgical system 14 comprising a secondsurgical instrument 17 and a second switch (e.g., 48, 56, 58, 62, 64, 70 & 140) for controlling the secondsurgical system 14. The former 210 can also include a second depression 214 for receiving the secondsurgical system 14. The second depression 214 can be adapted to produce an interference fit with at least a portion of the secondsurgical system 14. The secondsurgical system 14 can be loaded into the second depression 214. - The second depression 214 can include a second surgical instrument receiving portion 217 and a second switch receiving portion 215. The second
surgical system 14 can also include asecond conduit 15 and the second depression 214 can include a second conduit receiving portion 215. The secondsurgical system 14 can also include aproximal interconnection 148 and the second depression 214 can include a proximalinterconnection receiving portion 348. The interference fit can be formed with a portion of the secondsurgical instrument 17, a portion of the second switch (e.g., 48, 56, 58, 62, 64, 70 & 140), a portion of theproximal interconnection 148, or a combination thereof. In someformers 210, there will not be an interference fit between thesecond conduit 15 and the second conduit receiving portion 215. - As will be understood, additional
surgical systems 14 and depressions 214 can be included in order to produce any and all embodiments ofsurgical gloves 12 described herein. For example, the depressions 214 for receiving thesurgical systems 14 can be positioned in an index finger, a long finger or a little finger of the former 210. Similarly, as shown inFIGS. 1-4 , the thumb and the ring finger of the former 210 can be free of all depressions for receiving surgical systems 214. In someformers 210, the multiple depressions 214 do not intersect with one another in order to facilitate uniform coating of the surgical systems 214. - Depending of the desired configuration, the some or all of the
surgical systems 14 and discrete elements (e.g., 80, 82, 84, 86, 88, 90) can be loaded into the respective depressions 214 before or after the former 210 is dipped into the first coating precursor material. Where the surgical system(s) 14 and/or discrete elements (e.g., 80, 82, 84, 86, 88, 90) are loaded into the respective depressions after the former 210 is dipped into the coating precursor material, the former 210 will generally also be dipped into the coating precursor material after thesurgical systems 14 and/or discrete elements (e.g., 80, 82, 84, 86, 88, 90) are loaded into the former 210. - When the surgical system(s) 14 and/or discrete elements (e.g., 80, 82, 84, 86, 89, 90) are intended to be completely embedded in the glove, the method may be performed so that the former 210 is dipped both before and after the surgical system(s) 14 is/are loaded into the depressions 214 of the former 210. In such methods, the former 210 may be dipped more than once before the surgical system(s) 14 is/are loaded 210 and more than once after the surgical system(s) 14 is/are loaded into the former 210. For example, the former may be dipped into a polymer precursor (e.g., monomer solutions) or polymer solution (including, latex dispersion) and subsequently dipped into a solution containing one or more of a catalyst, an initiators, a coagulant, and a cross-linker.
-
FIGS. 1-4 depict a former 210 that can be used to make a glove that is the mirror image of the glove shown inFIG. 6 . InFIGS. 1-4 , the A series (FIGS. 1A, 2A, 3A & 4A ) shows various perspectives of the former 210 and the empty depressions 214 therein, while the B series (FIGS. 1B, 2B, 3B & 4B ) shows those same perspectives of the former 210 where the depressions 214 are loaded with thesurgical systems 14 and, in the case of 2B, discrete elements.FIGS. 1C and 4C show the volar perspective of the former 210 loaded with bothsurgical systems 14 and discrete elements. -
FIGS. 1-4 show various views of a former 210 used to form a left-handed glove. The former 210 can include asuction system depression 360. As shown in the volar view ofFIG. 1 , thesuction system depression 360 can include a suctiondevice receiving portion 220, a suction port controlswitch receiving portion 262, a suction controlport receiving portion 264, and a suctionconduit receiving portion 260. As shown inFIG. 2 , thesuction system depression 360 can include a terminalconnector receiving portion 348 proximate a wrist portion of the former 210. Thesuction system depression 360 can start proximate a distal end of the long finger and extend along volar aspects, radial aspects or volar-radial aspects of the long finger. As shown inFIG. 2 , thesuction system depression 360 can then continue to a dorsal side of the former 210 between the long finger and the index finger of the former and extend between or proximate the second and third metacarpals. - An exemplary interference fit for the
suction control port 64 is shown inFIG. 5B . Thesuction control port 64 can be an opening in thesuction conduit 60. As shown inFIG. 5B , suction controlport receiving portion 264 can include a suctioncontrol port projection 364 adapted for plugging thesuction control port 64. The fit between the sides of thesuction control port 64 and the suctioncontrol port projection 364 can be sufficient to prevent coating precursor from flowing between the sides and into thelumen 464 of thesuction conduit 60. - The former 210 can also include an
irrigation system depression 362. As shown in the volar view ofFIG. 1 , theirrigation system depression 362 can include an irrigationdevice receiving portion 222, an irrigation controlswitch receiving portion 270, and an irrigationconduit receiving portion 268. As shown in the dorsal view ofFIGS. 2A and 2B , theirrigation system depression 362 can include a terminalconnector receiving portion 348 proximate a wrist portion of the former 210. Theirrigation system depression 362 can start proximate a distal end of the little finger and extend along volar aspects, radial aspects or volar-radial aspects of the little finger. As shown inFIG. 2 , theirrigation system depression 362 can then continue to a dorsal side of the former 210 between the ring finger and the little finger of the former and extend between or proximate the fourth and fifth metacarpals (e.g., along an ulnar portion of the fourth or fifth metacarpal). - The former 210 can also include a
cutting system depression 364. As shown in the volar view ofFIG. 1 , the cuttingsystem depression 364 can include a cuttingdevice receiving portion 218, a cuttingswitch receiving portion 256, a coagulationswitch receiving portion 258, and a cuttingconduit receiving portion 252. As shown in the dorsal view ofFIG. 2 , the cuttingsystem depression 364 can include a terminalconnector receiving portion 348 proximate a wrist portion of the former 210. The cuttingsystem depression 364 can start proximate a volar aspect of the distal end of the index finger and extend along radial aspects of the index finger. As shown inFIG. 2 , the cuttingsystem depression 364 can then continue to a dorsal side of the former 210 between the thumb and index finger of the former and extend between or proximate the first and second metacarpals (e.g., along a radial portion of the second metacarpal). - An exemplary interference fit is shown in
FIG. 5A , which shows a cross-section of the relative positioning of the cuttingswitch 56 and cuttingswitch receiving portion 256, where the cuttingswitch 56 is a depression actuated switch. The cuttingswitch 56 can include abase 156 and a switch (e.g., button) 157 extending from thebase 156, where thebase 156 is wider than theswitch 157. Similarly, the cuttingswitch receiving portion 256 can be tiered to include abase receiving portion 356 and aswitch receiving portion 357 that extends deeper into the former 210 than thebase receiving portion 356. The width of thebase receiving portion 356 can be greater than the base 156 so that the coating precursor material can flow between the base 156 and thebase receiving portion 356 when the former 210 is dipped into the coating precursor. However, the width of theswitch receiving portion 357 and theswitch 157 can be substantially identical so that there is contact between the sides of theswitch 157 and theswitch receiving portion 357 sufficient to prevent the coating precursor from flowing between the sides, i.e., sufficient to form an interference fit. The depth of theswitch receiving portion 357 relative to theswitch 157 can be selected to allow coating precursor to flow between lateral faces 158, 258 of thebase 156 andbase receiving portion 256, as shown inFIG. 5A , or to form an interference fit between the lateral faces 158, 258. Of course, this interference fit configuration can apply to any of the switches—especially depression actuated switches—described herein (e.g., 48, 56, 58, 62, 64, 70) or envisioned for use with the methods and systems described herein. - The former 210 can also include one or more light source system depressions 366, 368. As shown in the dorsal view of
FIG. 2 , the light source system depressions 366, 368 can include lightsource receiving portions 216, light sourceswitch receiving portions 248, and a light sourceconduit receiving portions 242. As shown in the dorsal view ofFIG. 2 , the light source system depressions 364 can include a terminalconnector receiving portion 348 proximate a wrist portion of the former 210. - The first light
source system depression 366 can start proximate a distal end of a dorsal or distal aspect of the long finger and extend to an ulnar aspects of the long finger. As shown inFIG. 2 , the first lightsource system depression 366 can then continue to a dorsal side of the former 210 between the long finger and ring finger of the former and extend between or proximate the third and fourth metacarpals (e.g., along an ulnar portion of the third metacarpal). - Similarly, the second light
source system depression 368 can start proximate a distal end of a dorsal or distal aspect of the index finger and extend to an ulnar aspects of the index finger. As shown inFIG. 2 , the first lightsource system depression 368 can then continue to a dorsal side of the former 210 between the index finger and long finger of the former and extend between or proximate the second and third metacarpals (e.g., along an ulnar portion of the second metacarpal). - The former 210 can also include one or more discrete element depressions (e.g., 280, 282, 284, 286, 288, 290). As shown in the volar view of
FIG. 1 , aheat shield depression 280 can be positioned at a distal end of an index finger of the former 210. Theheat shield depression 280 can overlap with a portion of the cuttingdevice receiving portion 218 of the cuttingsystem depression 364. Theheat shield depression 280 can be generally rectangular or any other appropriate shape for use in connection with the cutting device. The cuttingdevice receiving portion 218 will generally extend deeper than theheat shield depression 280 so that the cuttingdevice 18 can be loaded, as shown inFIG. 1B , and then covered by theheat shield 80, as shown inFIG. 1C . Alternately, theheat shield 80 and cuttingdevice 18 can be a single element. In order to simplify the Figures,discrete element depressions FIG. 1 . - The former 210 can include at least one reinforcing
element depression FIG. 1 , a reinforcingelement depression 282 can be positioned at a distal end of a volar aspect of the thumb of the former 210. As shown inFIG. 2 , a reinforcingelement depression 286 can be positioned at a distal end of a dorsal aspect of the thumb of the former 210. These locations of the thumb may be reinforced in order to reduce wear when these locations are used to actuate switches embedded in, or protruding from, the glove. As will be understood, reinforcing elements can be positioned on any portion of the former 210 where it would be desired to reinforce the glove, including any aspect of the fingers and the volar or dorsal metatarsal region of the hand. The reinforcing element depression(s) can be generally rectangular or any other appropriate shape corresponding to the area where reinforcement in desired. In order to simplify the Figures, reinforcingelements FIGS. 1 and 2 , respectively. - The former 210 can include additional discrete element depressions, such as a
thermometer strip depression 284. The corresponding thermometer strip can visually indicate temperature for example by color. As shown inFIG. 1 , athermometer strip depression 284 can be positioned at a distal end of a volar aspect of the long finger of the former 210. Thethermometer strip depression 284 can be generally rectangular or any other appropriate shape corresponding to the area where reinforcement in desired. In order to simplify the Figures,thermometer strip depression 284 is only shown inFIG. 1 . - As shown in the end view of
FIG. 4 , at least onereflective element depression source receiving portions 216. As shown inFIG. 4 , a firstreflective element depressions 288 can be positioned at a distal end of the index finger and a secondreflective element depressions 290 can be positioned as a distal end of the long finger. Thereflective element depressions source receiving portions 216. Thereflective element depressions light source 16 can be loaded, as shown inFIG. 4B , and then covered by thereflective element FIG. 4C . Alternately, thereflective element light source 16 can be a single element. In order to simplify the Figures,reflective element depressions FIG. 4 . - The depths and fit of the depressions can be varied in order to leave appropriate portions of the
surgical systems 14 exposed after application of the coating and other portions completely embedded in the glove. For example, a loose fit may be desired around the conduits so that they are completely embedded in the polymer forming theglove 12. In contrast, an interference fit between portions of a depression and portions of a surgical system may be utilized in order to have certain portions exposed, e.g., switches, ports and interconnects. - In some methods, the former 210 may be dipped only up to the wrist in order to ensure that the proximal portions of the conduits (e.g., 42, 52, 60 and 68) and the
terminal connector 148 are exposed. For example, as shown inFIG. 2A , the former 210 may be dipped fingers first up to the wrist (line D) into a pool of coating precursor. Thus, the proximal portions of a conduit and theterminal connector 148 would be exposed. Alternately, the method could include removing portions of the glove in order to ensure that specific portions of thesurgical systems 14 are exposed. - It is known to use formers in the production of elastomeric gloves. These conventional formers are shaped similarly to the human hand and do not include depressions, especially depressions adapted to receive surgical systems and discrete elements such as those described herein. Thus, attachment of surgical systems to conventional elastomeric gloves would require post-formation attachment of the surgical system to the elastomeric gloves, which is inefficient and risks the integrity of the barrier function of the gloves. The claimed method and formers are a significant improvement over the conventional techniques. Accordingly, the invention is also drawn to the formers described herein for use in the methods described herein.
- The foregoing is provided for purposes of illustrating, explaining, and describing embodiments of this invention. Modifications and adaptations to these embodiments will be apparent to those skilled in the art and may be made without departing from the scope or spirit of this invention.
Claims (8)
1. A proximity switch system, comprising:
a self-contained power consuming device, comprising a power source in electrical communication with a power consuming element across a magnetic proximity switch; and
an external magnet removably coupled to said magnetic proximity switch.
2. The device according to claim 1 , wherein said external magnet is positioned to prevent the magnetic proximity switch from switching on when the device is not in use.
3. The device according to claim 1 , wherein the power source is a battery.
4. The device according to claim 1 , wherein the power consuming element is a light source.
5. The device according to claim 1 , wherein the proximity switch is a reed switch.
6. A method of storing and/or transporting a proximity switch system, comprising:
providing a self-contained power consuming device, comprising a power source in electrical communication with a power consuming element across a magnetic proximity switch; and
removably coupling an external magnet to said magnetic proximity switch in a position to prevent the magnetic proximity switch from inadvertently switching on.
7. The method of claim 6 , further comprising, transporting the self-contained power consuming device to a remote location.
8. The method to claim 6 , wherein the proximity switch is a reed switch.
Priority Applications (1)
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US16/377,601 US20190298467A1 (en) | 2011-09-26 | 2019-06-21 | Polymeric gloves having embedded surgical support systems and discrete elements |
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US201161539350P | 2011-09-26 | 2011-09-26 | |
US13/626,771 US9241764B2 (en) | 2011-09-26 | 2012-09-25 | Method of making polymeric gloves having embedded surgical support systems and discrete elements |
US14/988,464 US20160174636A1 (en) | 2011-09-26 | 2016-01-05 | Method of making polymeric gloves having embedded surgical support systems and discrete elements |
US201662331203P | 2016-05-03 | 2016-05-03 | |
US15/151,151 US10292781B2 (en) | 2011-09-26 | 2016-05-10 | Method of making polymeric gloves having embedded surgical support systems and discrete elements |
US16/377,601 US20190298467A1 (en) | 2011-09-26 | 2019-06-21 | Polymeric gloves having embedded surgical support systems and discrete elements |
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US15/151,151 Continuation US10292781B2 (en) | 2011-09-26 | 2016-05-10 | Method of making polymeric gloves having embedded surgical support systems and discrete elements |
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US16/377,601 Abandoned US20190298467A1 (en) | 2011-09-26 | 2019-06-21 | Polymeric gloves having embedded surgical support systems and discrete elements |
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CN112022328A (en) * | 2020-08-06 | 2020-12-04 | 上海交通大学医学院附属第九人民医院 | Medical gloves with electric knife electrode |
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US20160354068A1 (en) | 2016-12-08 |
US10292781B2 (en) | 2019-05-21 |
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