EP0619101A1
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Implantable inductively coupled medical identification system
Assignee: CR Bard Inc
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Filing: 1994-02-01
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Granted: —
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Expires: 2014-02-01
Abstract
Abstract A system for enabling the acquisition from outside the body of a patient (10) of data pertaining to a medical device (14) implanted therein. A characterization tag (90) is secured to the medical device (14) prior to the implantation thereof. The characterization tag (90) is powered by energy absorbed through the mutual inductive coupling of circuitry (398) in the characterization tag (90) with an alternating magnetic field (204) generated outside the body of the patient (10). That circuitry (398) in the characterization tag (90) is selectively loaded and unloaded in a predetermined sequence of loading conditions that correspond to data about the implanted medical device (14). The alternating magnetic field (204) is generated in a characterization probe (60) moveable external to the body of the patient (10). The characterization probe (60) includes electrical circuitry (420) for sensing variations in the amount of energy absorbed from the field (204) by the circuitry (398) in the characterization tag (90). The characterization tag (90) is secured in a characterization tag recess (106) on the exterior of the medical device (14) by a biocompatible potting material (104). If the medical device is assembled from a plurality of constituent parts, the characterization tag (90) may be permanently captured between a pair of those parts. Two single fluid reservoir access ports (14,230), a double fluid reservoir access port (280), a septum-free access port (320), and a prosthetic hip joint (370) are disclosed as examples of devices with which the system may be employed.
Inventors
- 👤 Guy J. Jordan
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 05:37
CPC Classifications
G; G06; G06K; G06K19/00; G06K19/06; G06K19/067; G06K19/07; G06K19/077; G06K19/07749; G06K19/07773; G06K19/07777; A; A61; A61B; A61B5/00; A61B5/0002; A61B5/0031; A61B90/00; A61B90/90; A61B90/98; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/32; A61F2/36; A61F2/3609; A61M; A61M39/00; A61M39/02; A61M39/0208; G06K7/00; G06K7/0008; A61B2562/00; A61B2562/08; A61F2002/30001; A61F2002/30667; A61F2002/30668; A61F2002/3067; A61F2002/3071; A61F2002/3611; A61F2002/3625; A61F2002/3631; A61F2002/365; A61F2/46; A61F2002/4688; A61F2002/4696; A61F2250/00; A61F2250/0001; A61F2250/0002; A61F2250/0058; A61F2250/0085; A61M2039/0211; A61M2039/0238; Y; Y10; Y10S; Y10S623/00; Y10S623/912
Claims Analysis
Total Claims: 57
Claim 1
Independent Claim
199 words
A system for permitting the acquisition from outside the body of a patient of data pertaining to medical devices implanted in the body of the patient at an implant location therein, the system being characterized by: (a) a medical device capable of subcutaneous implantation at a predetermined implant location in the body of the patient; and (b) a medical device data circuit secured to said medical device prior to the implantation thereof, said data circuit being powered by energy absorbed through the mutual inductive coupling thereof with an alternating magnetic field generated external to the body of the patient, said data circuit comprising: (i) field detection means for inductively coupling with said alternating magnetic field, and responsive thereto for generating a data circuit signal; and (ii) coding means electrically coupled to said field detection means for selectively loading and unloading said field detection means in a predetermined sequence of loading conditions responsive to said data circuit signal, said sequence of loading conditions corresponding to data pertaining to said medical device, and said loading and unloading of said field detection means correspondingly varying the amount of said energy absorbed from said alternating magnetic field in generating said data circuit signal.
Claim 2
Dependent Claim
128 words
A system as recited in Claim 1, further comprising a medical device characterization probe movable external to the body of the patient in the vicinity of the implant location, said identification probe comprising: (a) a hand-held housing moveable on the outside of the body of the patient in the vicinity of the implant location; (b) field generation means disposed within said housing and coupleable to a source of alternating electric power for generating said alternating magnetic field moveable with said housing on the outside of the body of the patient; and (c) sensor means disposed in said housing electrically coupled to said field generation means for producing a probe signal reflecting variations in said amount of said energy absorbed from said alternating magnetic field by said data circuit.
Claim 3
Dependent Claim
71 words
A system as recited in Claim 2, wherein said characterization probe further comprises digital decoding means in said housing electrically coupled to said sensor means for processing said probe signal to produce a digital data signal corresponding to said variations in said amount of said energy absorbed from said alternating magnetic field by said data circuit and for correlating said digital data signal with said data pertaining to said medical device.
Claim 4
Dependent Claim
43 words
A system as recited in Claim 3, wherein said identification probe further comprises display means electrically coupled to said digital decoding means and disposed on the exterior of said housing for giving a visual indication of said data pertaining to said medical device.
Claim 5
Dependent Claim
44 words
A system as recited in Claim 4, wherein said characterization probe further comprises means for scrolling said visual indication on said display means, thereby to enable a user to access data pertaining to the implanted medical device exceeding the capacity of said display means.
Claim 6
Independent Claim
32 words
A system as recited in any one of Claims 3-5, when said characterization probe further comprises means to electrically couple said digital decoding means to a computer external of said identification probe.
Claim 7
Independent Claim
59 words
A system as recited in any one of Claims 2-6, wherein said source of alternating electric power to which said field generating coil is coupleable comprises: (a) a battery disposed within said housing; and (b) power conversion means electrically coupled between said battery and said field generator means for converting direct current from said battery into alternating electric power.
Claim 8
Dependent Claim
12 words
A system as recited in Claim 7, wherein said battery is rechargeable.
Claim 9
Independent Claim
53 words
A system as recited in any one of Claims 2-6, wherein said source of alternating electric power to which said field generating coil is coupleable is external to said housing, and said characterization probe comprises a receptacle in said housing by which to effect electrical coupling with said source of alternating electric power.
Claim 10
Independent Claim
26 words
A system as recited in any one of Claims 3-9, wherein said characterization probe further comprises upgrade means for revising information in said digital decoding means.
Claim 11
Dependent Claim
46 words
A system as recited in Claim 10, wherein said upgrade means of said characterization probe comprises: (a) a selectively openable access portal formed through said housing: and (b) modular means for permitting the nondestructive removal and replacement of said digital decoding means through said access portal.
Claim 12
Independent Claim
80 words
A system as recited in any one of Claims 2-11, wherein said field generation means comprises a first resonant circuit in said housing of said characterization probe, said first resonant circuit comprising components defining a first resonant frequency associated therewith, and said component of said first resonant circuit comprising: (a) a field generating coil in said housing of said identification probe electrically coupled to said sensor means; and (b) a first capacitor connected in parallel to said field generating coil.
Claim 13
Independent Claim
242 words
A method for the acquisition from outside the body of a patient of data pertaining to a medical device implanted therein, the method comprising the steps of: (a) securing a characterization tag to a medical device capable of subcutaneous implantation in the body of the patient, said characterization tag comprising: (i) a structural substrate; (ii) a field detecting coil mounted upon said substrate, said field detecting coil being capable of inductively coupling with an alternating magnetic field generated external to the body of the patient and generating a detecting coil signal by absorbing energy from said alternating magnetic field; and (iii) coding means secured to said substrate and being electrically coupled to said field detecting coil for selectively loading and unloading said field detecting coil in a predetermined sequence of loading conditions responsive to said detecting coil signal, said sequence of loading conditions corresponding to data pertaining to said medical device, and said loading and unloading of said field detecting coil varying the amount of said energy absorbed from said alternating magnetic field in generating said detecting coil signal; (b) surgically implanting said medical device with said characterization tag secured thereto at a predetermined implant location in the body of the patient; (c) generating said alternating magnetic field external to the body of the patient in the vicinity of said implant location; and (d) sensing variations in said amount of said energy absorbed from said alternating magnetic field by said characterization tag.
Claim 14
Dependent Claim
81 words
A method as recited in Claim 13, further comprising the steps of: (a) producing a probe signal reflecting said variations in said amount of energy absorbed from said alternating magnetic field by said characterization tag; (b) processing said probe signal to produce a digital data signal corresponding to said variations in said amount of said energy absorbed from said alternating magnetic field by said characterization tag; and (c) correlating said digital data signal with said data pertaining to said medical device.
Claim 15
Dependent Claim
24 words
A method as recited in Claim 13, further comprising the step of providing a visual indication of the data pertaining to said medical device.
Claim 16
Dependent Claim
82 words
A method as recited in Claim 13, wherein said alternating magnetic field is generated in a first resonant circuit housed in a hand-held identification probe, said first resonant circuit comprising: (a) a field generating coil housed in said identification probe coupleable to a source of alternating electric power; and (b) a first capacitor connected in parallel to said field generating coil, said field generating coil and said first capacitor together defining a first resonant circuit having associated therewith a first resonant frequency.
Claim 17
Dependent Claim
42 words
A method as recited in Claim 15, wherein a second capacitor is connected in parallel to said field detecting coil, said second capacitor in combination with said field detecting coil defining a second resonant circuit having associated therewith a second resonant frequency.
Claim 18
Dependent Claim
45 words
A method as recited in Claim 13, wherein said step of securing comprises the steps of: (a) forming a characterization tag recess in a surface of said medical device; and (b) securing said characterization tag in said characterization tag recess utilizing a biocompatible potting material.
Claim 19
Dependent Claim
39 words
A method as recited in Claim 13, wherein said step of securing comprises the steps of: (a) assembling said medical device from a plurality of components; and (b) permanently capturing said characterization tag between a pair of said components.
Claim 20
Independent Claim
31 words
A system or method as recited in any one of Claims 12 or 16, wherein said field generating coil comprises: (a) a core; and (b) a conductor wrapped about said core.
Claim 21
Dependent Claim
53 words
A system or method as recited in Claim 20, wherein said core assumes a generally elongate shape having a longitudinal axis, and said longitudinal axis is oriented toward the skin of the patient when said characterization probe is moved external to the body of the patient in the vicinity of the implant location.
Claim 22
Dependent Claim
15 words
A system or method as recited in Claim 20, wherein said core is generally C-shaped.
Claim 23
Independent Claim
81 words
A system or method as recited in any one of Claims 20 or 21, wherein said core terminates in first and second non-parallel, flat, flux-transmitting surfaces, said first and second flux-transmitting surfaces defining corresponding first and second flux-transmitting planes, said first and second flux-transmitting planes forming a dihedral angle the interior of which is oriented toward the skin of the patient when said characterization probe is moved external to the body of the patient in the vicinity of the implant location.
Claim 24
Dependent Claim
73 words
A system as recited in Claim 12, wherein said field detection means comprises a second resonant circuit secured to said medical device, said second resonant circuit comprising components defining a second resonant frequency associated therewith, said component of said second resonant circuit comprising: (a) a field detecting coil secured to said medical device and electrically coupled to said coding means; and (b) a second capacitor connected in parallel to said field detecting coil.
Claim 25
Independent Claim
27 words
A system or method as recited in any one of Claims 17 or 24, wherein said second resonant frequency is substantially equal to said first resonant frequency.
Claim 26
Independent Claim
39 words
A system as recited in any one of Claims 12 or 24, further including a characterization tag, said characterization tag comprising a structural substrate having said field detection means and said coding means of said data circuit secured thereto.
Claim 27
Dependent Claim
28 words
A system as recited in Claim 26, wherein said substrate of said characterization tag comprises a capacitor electrically coupled between said field detection means and said coding means.
Claim 28
Independent Claim
31 words
A system or method as recited in any one of Claims 24 or 25, wherein said field detection coil comprises: (a) a core; and (b) a conductor wrapped about said core.
Claim 29
Independent Claim
23 words
A system or method as recited in any one of Claims 20 or 28, wherein said core is comprised of a ferrous material.
Claim 30
Independent Claim
23 words
A system or method as recited in any one of Claims 20 or 28, wherein said core is comprised of a non-ferrous material.
Claim 31
Dependent Claim
26 words
A system as recited in Claim 26, wherein said substrate, said field detecting means and said coding means are encapsulated in a moisture proof, biocompatible material.
Claim 32
Dependent Claim
15 words
A system as recited in Claim 31, wherein said biocompatible material comprises a Parylene™ coating.
Claim 33
Dependent Claim
17 words
A system as recited in Claim 32, wherein said Parylene™ coating is enclosed in an ultraviolet adhesive.
Claim 34
Independent Claim
42 words
A system as recited in any one of Claims 26 or 27, wherein said characterization tag comprises an elongate member having a diameter less than or equal to approximately 2.5 millimeters and a length less than or equal to approximately 6.0 millimeters.
Claim 35
Independent Claim
41 words
A system as recited in any one of Claims 26 or 27, wherein said characterization tag comprises a disc having a thickness less than or equal to approximately 2.5 millimeters and a diameter less than or equal to approximately 20.0 millimeters.
Claim 36
Independent Claim
40 words
A system as recited in any one of Claims 1-12, 24, 26-27, or 31-35, wherein a data circuit recess is formed in the exterior of said medical device, and wherein said data circuit is disposed in said data circuit recess.
Claim 37
Independent Claim
37 words
A system as recited in any one of Claims 1-12, 24, 26-27, or 31-35, wherein said medical device comprises a plurality of components, and wherein said data circuit is permanently captured between a pair of said components.
Claim 38
Independent Claim
86 words
A system or method as recited in any one of Claims 1-37, wherein said coding means comprises: (a) article characterization means for storing data pertaining to said medical device and for reading out said data in a timed sequence by loading said field detection means in said predetermined sequence of loading conditions; and (b) timer means electrically coupled between said field detection means and said article characterization means for driving said article characterization means to read out said data in response to said data circuit signal.
Claim 39
Dependent Claim
73 words
A system or method as recited in Claim 38, wherein said article characterization means comprises: (a) an electrical load: (b) a switching circuit for selectively coupling and uncoupling said load to said field detection means; and (c) a memory means coupled to said switching circuit for storing said data pertaining to said medical device and for reading out said data by driving said switching circuit in a timed sequence corresponding to said data.
Claim 40
Independent Claim
52 words
A system or method as recited in any one of Claims 38 or 39, wherein said timing means comprises a timer circuit coupled between said field detection means and said memory means, said timer circuit being activated by said data circuit signal to drive said memory means to read out said data.
Claim 41
Independent Claim
21 words
A system or method as recited in any one of Claims 1-40, wherein said medical device comprises an implantable access port.
Claim 42
Dependent Claim
98 words
A system or method as recited in Claim 41, wherein said access port comprises: (a) a needle-impenetrable housing having said data circuit secured thereto, said housing enclosing a fluid cavity and defining an access aperture communication through said housing with said fluid cavity; (b) a needle-penetrable septum captured by said housing and sealing said access aperture; and (c) an outlet stem connected at a proximal end thereof with said housing, said outlet stem enclosing an outlet passageway communicating with said fluid cavity and being configured at a distal end thereof to receive the proximal end of a catheter.
Claim 43
Dependent Claim
84 words
A system or method as recited in Claim 42, wherein said housing comprises: (a) a generally planar floor; (b) a top wall disposed opposite said floor generally parallel thereto, said first access aperture being formed through said top wall of said housing: (c) side walls extending from the periphery of said floor to the periphery of said top wall; and (d) a needle-penetrable material encasing the exterior of said floor of said housing and the exterior of portions of said side walls adjacent thereto.
Claim 44
Dependent Claim
20 words
A system as recited in Claim 43, wherein said data circuit is disposed between said housing and said needle-penetrable material.
Claim 45
Dependent Claim
99 words
A system or method as recited in Claim 42, wherein said housing comprises: (a) a base having a flat floor and walls normal to an upstanding therefrom, said walls defining said first fluid cavity; and (b) a cap configured to receive said base, said cap comprising: (i) a top wall having formed therein said access aperture at a position opposite said fluid cavity when said base is received in said cap; and (ii) a skirt depending from the periphery of said top wall, said skirt enclosing said walls of said base when said cap is received in said base.
Claim 46
Dependent Claim
156 words
A system or method as recited in Claim 41, wherein said access port comprises: (a) a needle-impenetrable housing having said data circuit secured thereto, said housing enclosing a first fluid cavity and a second fluid cavity, and said housing defining a first access aperture communicating though said housing with said first fluid cavity and a second access aperture communicating through said housing with said second fluid cavity; (b) a first needle-penetrable septum captured by said housing and sealing said first access aperture; (c) a second needle penetrable septum captured by said housing and sealing said second access aperture; and (d) an outlet stem connected at a proximal end thereof with said housing, said outlet stem enclosing a first outlet passageway communicating with said first fluid cavity and a second outlet passageway communicating with said second fluid cavity, and said outlet stem being configured at a distal end thereof to receive the proximal end of a catheter.
Claim 47
Dependent Claim
204 words
A system or method as recited in Claim 46, wherein said housing comprises: (a) a base having a flat floor and walls normal to an upstanding therefrom, said walls defining said first fluid cavity and said second fluid cavity; (b) a planar septum support configured to mate with the ends of said walls of said base opposite said floor of said base, said septum support having formed therethrough a first septum receiving aperture positioned above said first fluid cavity and second septum receiving aperture position above said second fluid cavity: and (c) a cap configured to receive said septum support and said base, said cap comprising; (i) a top wall having formed therein a first septum access aperture at a position opposite said first septum receiving aperture when said septum support and said base are received in said cap and a second access aperture at a position opposite said second septum receiving aperture when said septum support and said base are received in said cap; and (ii) a skirt depending from the periphery of said top wall of said cap, said skirt enclosing said septum support and said walls of said base when said septum support and said base are received in said cap.
Claim 48
Dependent Claim
77 words
A system or method as recited in Claim 47, wherein a data circuit recess is formed in a surface of said base contacted by said septum support when said septum support mates with said ends of said walls of said base opposite from said floor of said base, and wherein said data circuit is disposed in said data circuit recess prior to the mating of said septum support with said ends of said walls of said base.
Claim 49
Dependent Claim
64 words
A system or method as recited in Claim 47, wherein a data circuit recess is formed in a surface of said septum support contacted by said cap when said base and said septum support are received in said cap, and wherein said data circuit is disposed in said data circuit recess prior to said base and said septum support being received in said cap.
Claim 50
Independent Claim
60 words
A system or method as recited in any one of claims 47 or 49, wherein a data circuit recess is formed in a surface of said base contacted by said cap when said base is received in said cap, and wherein said data circuit is disposed in said data circuit recess prior to said base being received in said cap.
Claim 51
Dependent Claim
125 words
A system or method as recited in Claim 41, wherein said implantable access port comprises: (a) a needle-impenetrable housing enclosing and defining the following: (i) a valve chamber; (ii) an outlet passageway communicating between said valve chamber and the exterior of said housing; (iii) a non-linear entry passageway communicating at the distal end thereof with said valve chamber and at the proximal end thereof with the exterior of said housing; and (iv) a funnel-shaped entrance orifice formed in the surface of said housing communicating at the narrow end thereof with said proximal end of said entry passageway; and (b) a leaflet valve captured in said valve chamber by said housing, thereby to provide a selectively-openable fluid seal between said entry passageway and said outlet passageway.
Claim 52
Dependent Claim
104 words
A system or method as recited in Claim 51, wherein said leaflet valve comprises: (a) a first leaflet valve disk having formed therethrough a centrally-disposed diametrically-aligned first slit; (b) a second leaflet valve disk having formed therethrough a centrally-disposed, diametrically-aligned second slit, said secondly leaflet valve being positioned in mating contact with said first leaflet valve with said second slit disposed at an angle to said first slit; and (c) a sealing disk having a centrally-disposed aperture formed therethrough, said sealing disk being positioned in mating contact with said second leaflet valve disk on the side thereof opposite from said first leaflet valve disk.
Claim 53
Independent Claim
84 words
A system or method as recited in any one of Claims 51 or 52, wherein said housing comprises: (a) a needle-impenetrable body portion defining therewithin said valve chamber, said entry passageway, said entrance orifice, and an access aperture communicating through said housing with said valve chamber on the side of said valve chamber opposite said entry passageway; and (b) a valve chamber plug defining therewithin said outlet passageway and being securable in said access aperture to capture said leaflet valve in said valve chamber.
Claim 54
Dependent Claim
69 words
A system or method as recited in Claim 53, wherein said valve chamber plug comprises: (a) a base portion configured to be secured in said access aperture; and (b) an outlet stem projecting from the side of said base portion opposite said valve chamber, said outlet stem enclosing said outlet passageway, and the distal end of said outlet stem being configured to receive the proximal end of the catheter.
Claim 55
Independent Claim
21 words
A system or method as recited in any one of Claims 1-40, wherein said medical device comprises an implantable prosthetic article.
Claim 56
Dependent Claim
16 words
A system as recited in Claim 55, wherein said prosthetic article comprises a hip joint transplant.
Claim 57
Independent Claim
31 words
A system or method as recited in any one of Claims 36, 37, or 48-50, wherein said data circuit is retained in said data circuit recess by a biocompatible potting material.
References Cited (Backward Citations)
US4333072A
Cited
US4863470A
Cited
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