Sensor introducer system, apparatus and method
First Claim
1. An introducer, to provide subcutaneous access into a subject for a measurement device, said introducer comprising:
- a cannula having a lumen extending between proximal and a distal ends, said proximal end being associated with affixing structure adapted to resist motion of said proximal end relative to a skin surface of the subject; and
a substantially planar housing having a bottom surface and a thickness, disposed substantially transverse to said bottom surface, that is less than about one-fourth the size of a maximum width of said bottom surface, said housing being arranged to dispose a first guide structure in association with said proximal end of said lumen, said first guide structure providing a conduit having a first opening arranged to provide a forgiving target, said first opening being disposed at a first end of said conduit and being sized larger than a size of an opening at said proximal end of said lumen, said conduit being reduced in size at a second opening at a second end that is directed distally toward said lumen, and through which first opening to receive in series a removable insertion needle point and a probe tip of a measurement device to facilitate guiding said tip into said proximal end of said cannula.
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Accused Products
Abstract
An assembly including an introducer cannula and subcutaneous measurement device, and a method of its use. The device can form an aseptic seal to the introducer to resist passage of pathogens through the cannula. Insertion of the device into the introducer desirably causes a one-way coupling operable to force removal of the introducer and device as a single assembly. Installation of certain devices into certain introducers forms an electrical connection between an electrode carried by the introducer and system electronics. Desirably, the introducer provides a funnel-like structure operable to guide a device'"'"'s probe tip into reception in the introducer'"'"'s cannula.
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Citations
38 Claims
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1. An introducer, to provide subcutaneous access into a subject for a measurement device, said introducer comprising:
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a cannula having a lumen extending between proximal and a distal ends, said proximal end being associated with affixing structure adapted to resist motion of said proximal end relative to a skin surface of the subject; and
a substantially planar housing having a bottom surface and a thickness, disposed substantially transverse to said bottom surface, that is less than about one-fourth the size of a maximum width of said bottom surface, said housing being arranged to dispose a first guide structure in association with said proximal end of said lumen, said first guide structure providing a conduit having a first opening arranged to provide a forgiving target, said first opening being disposed at a first end of said conduit and being sized larger than a size of an opening at said proximal end of said lumen, said conduit being reduced in size at a second opening at a second end that is directed distally toward said lumen, and through which first opening to receive in series a removable insertion needle point and a probe tip of a measurement device to facilitate guiding said tip into said proximal end of said cannula. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. An introducer system for a biosensor, said introducer system comprising:
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an introducer assembly comprising a cannula having a lumen extending between proximal and distal ends, said proximal end being associated with a housing that carries affixing structure adapted to resist motion of said proximal end relative to a skin surface of a subject, said housing further carrying holding structure configured to interface individually in series with first structure associated with an installation needle and with second structure associated with said biosensor;
an installation needle assembly comprising said first structure and said installation needle, said needle being structured for insertion into said lumen to facilitate installation of a distal end of said cannula into a subcutaneous target site of the subject, said needle being removable from said cannula subsequent to placement of said distal end of said cannula at said subcutaneous target site; and
a biosensor comprising said second structure and a probe portion configured and arranged to permit a distal probe end to slide through said lumen to dispose said probe end at said site when forming an interface between portions of said holding structure and said second structure, said biosensor further being arranged in harmony with said housing to form a barrier operable to resist passage of outer contaminants into said lumen subsequent to forming said connection. - View Dependent Claims (20, 21, 22, 23, 24, 25)
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26. An introducer system for inserting a probe into a subcutaneous target site in a subject,
said introducer system comprising: -
an introducer assembly comprising;
a cannula having a lumen extending axially between a proximal end and a distal end, said proximal end being associated with affixing structure adapted to resist motion of said proximal end relative to a skin surface of the subject; and
a housing associated with said proximal end of said cannula and providing holding structure, said introducer assembly being configured to interface separately with;
a needle assembly comprising an extended needle shaft configured for placement through said lumen to dispose a needle point distally to said distal end of said cannula, said needle shaft being structured to facilitate subcutaneous insertion of said distal end of said cannula into the subject, a portion of said needle assembly being structured and arranged in harmony with a portion of said holding structure to effect a releasable coupling therebetween to permit withdrawal of said needle shaft subsequent to placement of said distal end of said cannula in proximity to said site; and
a device comprising a proximal probe end spaced apart from a distal probe end, said distal probe end being structured for sliding installation through said lumen to said subcutaneous target site, said proximal probe end being associated with structure adapted to form a one-way coupling with structure associated with said holding structure effective to resist withdrawal of said distal probe end from said cannula. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33)
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34. An introducer system, for inserting a probe into a subcutaneous target site in a subject, comprising:
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an introducer assembly comprising;
a cannula having a lumen extending axially between a proximal end and a distal end, said cannula carrying a first electrode component of a biosensor, said proximal end being associated with affixing structure adapted to resist motion of said proximal end relative to a skin surface of the subject; and
a housing associated with said proximal end of said cannula and providing holding structure, said introducer assembly being configured to interface separately with;
a needle assembly comprising an extended needle shaft configured for placement through said lumen to dispose a needle point distally to said distal end of said cannula, said needle shaft being structured to facilitate subcutaneous insertion of said distal end of said cannula into the subject, a portion of said needle assembly being structured and arranged in harmony with a portion of said holding structure to effect a releasable coupling therebetween to permit withdrawal of said needle shaft subsequent to placement of said distal end of said cannula in proximity to said site; and
a device comprising a proximal probe end spaced apart from a distal probe end, said distal probe end being structured for sliding installation through said lumen to dispose a second electrode component of said biosensor at said subcutaneous target site;
wherein;
assembly of said device into mating reception in said holding structure completes an electrically conductive path between said first electrode and an element of a sensor cable carried by said device. - View Dependent Claims (35)
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36. A method for installing an element of a biosensor into a subcutaneous site in a subject, said method comprising:
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providing a cannula having a lumen extending between a proximal end and a distal end, said proximal end being associated with holding structure adapted to interface with an inserter needle assembly, said lumen containing an extended needle shaft of said inserter needle assembly;
using said inserter needle assembly to insert said distal end of said lumen into proximity to the subcutaneous site;
withdrawing said needle shaft from said lumen to provide open communication through said lumen to the subcutaneous site;
affixing structure associated with said proximal end of said cannula to a skin surface of the subject; and
inserting a probe tip of a measurement device into said lumen and bringing said device into seated engagement with said holding structure to form a one-way connection operable to resist tool-free removal of said probe tip from said lumen. - View Dependent Claims (37, 38)
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Specification