CA2142995A1

CA2142995A1 - Implant with electrical transponder marker

Info

Publication number: CA2142995A1
Application number: CA002142995A
Authority: CA
Inventors: Terry Russell Knapp; Thomas Lawrence Monsees; Winston A. Andrews
Original assignee: Individual
Current assignee: Lipomatrix Inc
Priority date: 1992-08-24
Filing date: 1993-08-05
Publication date: 1994-03-03
Also published as: EP0703760A1; US5300120A; EP0703760A4; AU5003093A; ATE189375T1; AU674022B2; DE69327802D1; DE69327802T2; EP0703760B1; WO1994004094A1; JPH08501956A; US5674288A; BR9306947A

Abstract

A passive transponder (28) may be encoded with a number or code of up to 64 binary bits and then mounted to virtually any prosthesis implanted in a human, such as a breast implant. After implanta-tion, the transponder's code may be conveniently read with a hand held electromagnetic reader (24) which may merely be brought within proximity of the transponder (28). The encoded transponder (28) may thus be read in a non-invasive procedure and without the use of any sophisticated or potentially harmful medical equipment or technology such as X-ray. The information encoded in the transponder (28) may correspond to patient demographics and implant da-ta to aid in tracking the implant's manufacturer and use for medical as well as legal reasons.

Description

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IMPLANT WITH ELECTRICAL TRANSPONDER MARKER
Background and SummarY of the Invention With the advance of me~Al tech~ology, there are a number of medical pros~heC~C and devices which are im-plantable in humans for re-constructive and/or cosmetic purposes. These include breast implants; penile im-5 plants; musculature and other soft tissue implants; pacemakers; valves; artificial ~oints and limbs such as knees, shoulders, legs, fingers, etc.; pins; screws;
plates; rods; nails and other braces and supports. In order to ensure the cont~ safety and health of pa-10 tients receiving these implants, the Safe Medical DeviceAct of 1990 has been enacted which dictates that manufac-turers of Class III implantable medical devices institute a device registry for trAcklng of their devices, notifi-cation of patients, and otherwise monitoring these im-15 plants after they have been placed in a patient. Compli-ance with this Act has been proposed through a method of tracking which requires the surgeon who implants the device to complete and return a form or card with patient demographic data and implant data to the manufacturer or 20 to a third party registry service. This method re~uires 21~2~S
W094/04094 "~ ^ PCT/US93/0749 careful accumulation of data by a surgeon or his staff as well as secure inventory control proce~l~res in order ~o ensure that the data ~s properly ~sco~ted with the correct implant. Addit~Ally, there is a risk of 108S
5 of the data entirely resulting from ~s~rected or lost _ ~nicAtions. Furthermore, ~cce~ to this data can be impeded in the event of an emergency situation or other circumstAncec which inter$ere with a patient's ability to recall or ~e~L~ the proper information wh~ch me~o~l 10 personn~l may then use to Aa~eS-c the registry and data contAln~ therein.
There have been some suggestions in the prior art of marking the implants the~eclves with, for example, a radiopaque marker or other marker which contains the 15 information relating to the implant. Ideally, this data could then be viewable by X-ray or some other non-inva-sive manner. Ho~_v~l, there are difficulties with these prior art a~LoA~h~. First of all, a breast lmplant with a radiopaque marker would at least partially o~ .e 20 or mask tissue which is desired to be viewed in order to detect artifacts relating to tumors or the like for diag-nosing cAnc~r. Obviously, this is highly ~n~-Q~rable as the ;n~ence of breast ~A~c~r presents a significant risk to many females. Additionally, repeated exposure to 25 X-ray is not generally considered healthful or desirable and represents at least an added ~nConven~nce entAil~ng some degree of exr~-ns~- to recall or access the implant data. Therefore, radiopaque markers have not been viewed as a suitable long-term solution to this problem.
In order to solve these and other problems in the prior art, and in order to provide a cullvel~ient, fool proof marker secured to the implant itself and yet read-able in a non-invasive r~nn~r, the inventors herein have sl~cee~ in designing and developing an implant which 35 incorporates a passive transro~çr which may be encoded and subsequently ~r~ A with a hand held electromagnet-~ W094/04094 2 1 ~ 2 9 3 iS PCT/US93/07499 ic reader in a quick and ~nex~cive proceAt-re. The passive transronAer may be secured to the implant by any convenient means. For example, in a breast implant, the multi-layered shell for the implant may be laminated 5 around the transronA~r to thereby be permanently and securely fixed to the implant. The transpQnAer may be laminated in the ~idewall of the shell, or between layers which comprise the seal patch which is applied to the shell to seal the mandrel or~ ng. Similarly, the tran-10 sponA~r may be laminated onto the surface of most otherimplants in an unobtrusive location. In some other im-plants, the transronA~r may be inserted into a hole or inlay and ~A l~A in place.
As passive transro~A~rs are commercially avA~lAhle 15 in a cylindrical shape sized at 2 mm in diameter and 11 mm in length, the patient will not sense any discom-fort or even the precAnce of the transronA~r. Also, the transponAer may be e~r,oA~A~ with any suitable enCoA~ng scheme. A commercially aVA~lAhle transr~nAe~ presently 20 provides for the storage of up to 64 binary bits of data.
This data rAp~r,~ty may accommodate the direct storage of much, if not all, of the information desired to be re-corded and maintA~n~A in a device registry. Furthermore, the storage r~p~c~ty of the transponA~ is expected to be 25 increased as further development occurs over time. Al-ternately, a number, roll~ction of numbers, combination of numbers and le~ters, or other indirect code may be stored which after r~;ng may be used to Arr~CS a data bank which itself contains the desired information. Of 30 course, if information is directly stored in the implant, it becomes immediately aVA i 1 ~hl e upon re~A~ng the tran-sponA~r. This provides ready Acr~s~ to information in emergency situations. Alternately, with the widespread availability, ~rr~c~ibility~ and use of computers over 35 telecommunications networks including telep~on~ lines, it is not generally considered to be unduly limiting to 214~5 ~ .
W094/04094 ~ PCT/US93/07499 -provide that the code read from the transpon~er be then used to ~ccess an a~ iate data bank in order to ob-tain the patient demogrAph~cs, manufacturer's name, date of manufacture, surgeon' 8 name, date of implantation, 5 etc.
A comp~n~o~ hand held electromagnetic reader is also commercially aVA~ 1 ~hl e wh~ch emits a low frequency magnetic field to activate the passive transronADr and thereby cause it to transmit its encoAe~ data to the lO reader. With this particular commercial device, no bat-tery or other sou ~e of electrical power need be included in the passive transpon~er. This further reduces the size required for the transpo~ADr and renders it particu-larly suitable to this application.
While the principal advantages and features of the present invention have been described above, a more com-plete and thorough underst~A~g of the invention may be attA~nD~ by referring to the drawings and description of the preferred embodiment which follow.
20 8rief Description of the Drawinqs Figure 1 is a perspective view of a breast implant contA~ n~ ng a passive transpon~er with a hand held reader in position to read the enco~DA data contA~ne~ therein;
Figure 2 is a partial cros~-sectionAl view of the 25 transpon~Dr as laminated between the multiple layers ~f a seal patch for a breast implant, Figure 3 is a perspective view of a pectoralis muscle implant with a passive transp~n~Dr mounted there-in;
Figure 4 is a perspective view of a soft chin im-plant with passive transponder mounted therein;
Figure 5 is a perspect~ve view of a rigid chin implant with a passive transpo~r mounted therein;
Figure 6 is a perspective view of a nipple trans-35 plant with a passive transponder mounted therein;

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Figure 7 is a perspective view of an otoplasty implant with a passive transponder mounted therein;
Figure 8 is a perspective view of a penile im-plant, surgically implanted, with a passive transpsnA~r 5 mounted therein;
Figure 9 is a top view of a pace maker with a pas-sive transponder mounted thereon;
Figure 10 is a top view of a heart valve with a passive transponder mounted to the edge thereof;
Figure 11 is a perspective view of a total knee ~oint prosthesis with a passive transpon~ mounted thereon;
Figure 12 is a perspective view of a shoulder ar-throplasty system with a passive transpo~e~ mounted 15 therein;
Figure 13 is a partial cross-sect~on~l view of a passive transponA~r ~ nl A~ A into and below the surface of an implant;
Figure 14 is a perspective view of a femoral fixa-20 tion system implanted in a femur with a passive trans-ponAer mounted thereto:
Figure 15 is a perspective view of an orthopedic nailing system with a passive transponAer mounted there-in;
Figure 16 is a perspective view of a finger ~oint prosthesis with a passive transron~er mounted therein;
Figure 17 is a perspective view of a craniomaxil-lofacial plating system with a passive transponAe~ mount-ed therein;
Figure 18 is a perspective view of still another plating system with a passive transponder mounted there-in; and Figure 19 is a partial cross-sectional view of a typical implant with a passive transponA~ mounted within 35 a cored hole drilled therein.

W094/04094 2 1 ~ 2 ~ t ~ ' PCT/US93/074 ~

Detailed DescriPtion of the Preferred EmboA~ -It As shown in Figure 1, a-breast implant 20 has been implanted in a female's breast 22 and includes a ~ conP
shell 24 inflated with an a~lo~l1ate fill material 26.
5 At the posterior side of the implant 20 is shown the trans~onAer 28 which has been laminated between ad~acent layers 30, 32 of the shell 24. Transpon~Pr 28 may be any passive transponApr such as a Trovan Model ID100 avail-able from Ele~Llo,lic Identification Systems Ltd. of Santa 10 Barbara, California. This particular transpQnAPr is designed to be environmentally ~n~ep~nAPnt and suitable for operation while being directly submerged in liquids.
Furthermore, it may be read spherically from any direc-tion through most materials, and including most impor-15 tantly those materials comprising implants for the humanbody. The transponA~r may be directly PncoAPr~ with up to 64 binary bits of data to provide almost one trill~on ro~s~hle diffelel.~ code combinations. It is anticipated that FDA a~ val will be forthcoming for its use as part 20 of the invention disclosed and claimed herein.
A hand held reader 34 is also shown in Figure 1 and may be a Trovan Model LID500, or other suitable de-vice. Its principle of operation includes emitting a low frequency magnetic field for activating the passive tran-25 sponApr 28. As such, transponder 28 has no power sourceand instead derives the energy nePAPA for its operation from the magnetic field generated by the reader 34. This permits the transponA~r 28 to have a virtually unlimited life span. The hand held reader 34 is shown ~onnected to 30 a AecoAPr ~o--~loller 36 which Ac~es a data bank 38 in response to the detected code cont~;neA within transpond-er 28 to thereby access such data which has been stored corresponA~g to transponder 28. Alternately, as men-~; on~ above, the hand held reader 34 may be used to ac-35 cess the code cont~i~e~ within transponder 28 and thenother means used to access a data bank for the retrieval W094/04094 2 i ~ 2 9 ~ 5 PCT/US93/07499 of the desired information. Such means might include the use of a tel~phon~ and modem to ~cce~s a registry con-tA~neA in a geographically centrally located site.
As shown in Figure 2, the transp~nA~r 28 may be 5 laminated ~e~ n ad~acent layers 40, 42 of the seal patch 44 which is commonly used to seal the mandrel open-ing 46 in a shell 48 of a breast implant 50. For other implants, oG-lv~lient mounting locations may be readily determined with due consideration given to avo~ A ~ n~ dis-10 comfort to the patient as well as optimizing r~-~AAh~l~ty of the transronApr with the hand held reader.
As shown in Figure 3, a pectoralis muscle implant 52 may ~ollve~iently have a passive transro~r 54 con-t~ne~ therein. The passive transponA~r 54 may be molded 15 in place, or a hole or inlay drilled for placement of the implant, after which the implant surface may then be ref~ n~ ~heA .
As shown in Figures 4 and 5, a soft chin implant 56 or a hard chin implant 58 may also have a passive 20 transronA~r 60, 62 mounted therein. As shown in Figure 6, a nipple implant 64 has a passive transpon~r 66 mounted internally. In all of these transplants, the mounting of the passive transronAer is achieved to pro-vide minimal discomfort or sensation to the patient, as 25 well as to avoid interference with the cosmetic appear-ance of the implant. As shown in Figure 7, an otoplasty implant 68 may have a passive transronAe~ 70 mounted therein. As shown in Figure 8, a penile implant 72 may have a passive transronA~r 74 mounted therein.
As shown in Figure 9, a pace maker 76 may also have a passive transronAer 78 mounted either on its sur-face or below the protective metal casing thereof. The inventors have found that reading of the passive tran-sro~A~ by the hand held reader may be achieved even when 35 the transponder is obscured by metallic surfaces. As shown in Figure 10, a heart valve 80 may have a passive W094/04094 2 1 ~ 2 9 9 5~ t~, PCT/US93/0749 ~

transponder 82 mounted to its edge in order to avoid interference with the operability thereof, or fixation thereof.
As shown in Figures 11 and 12, a total knee ~oint S prosthec~ 8 84 or a shoulder ~ o~he-c1~ 86, either one of which includes a ma~or~ty of parts made from titanium or the like, may also conveniently carry a passive trans-r~n~ 88, 9o.
As shown in Figure 13, the passive trAnsrQn~ 92 10 may be rl~ce~ within a trough 94 or the like and ~veLed with a ~s~l~nt 96 so that the surface of the transpon~r 98 is uninterrupted and smooth as is desirable in many transpon~ rs.
As shown in ~igures 14 and 15, a femoral fixation 15 ~ nt 100, or an orthopedic ~ g ~y~ 102 may cG.lvelliently have a passive transpnn~ 104, 106 ~nl~
therein. As shown in Figure 16, a finger ~oint ~o-~Lhe-sis 108 may also have a passive transponA~r 110 located in a position which does not interfere with the movable 20 Joint portion 112 of the prosthec~ 108. As shown in Figures 17 and 18, a crani~ nfacial plating ~y~en.
114 or any other plating ~y5 t- 116 may also ~nv~lliently include a passive transpon~r 118, 120. As an alterna-tive to the inlay mounting shown in Figure 13, a hole 122 25 may be drilled in any convenient location of an implant 124 and the passive transponder 126 inserted therein and sealed in place by sealer 128, with the outer surface of sealer 128 being f 1 ni ~he~ to provide a smooth surface on implant 124.
As disclosed herein, a wide variety of implants made of all sorts of material may conveniently include a passive transpo~r which may be implanted, and then read by the hand held reader. This compatibility and ease of operation permits the use of a passive transpn~.r with 35 virtually any implant. The inventors have disclosed herein a representative sample of such implants. Howev--W094/04094 2 1 ~ 2 9 ~ S PCT/US93/07499 er, the scope of the present invention ls broad enough to encompass any ~mplant presently known to the inventors herein.
There are various changes and modifications which 5 may be made to the invention as would be apparent to those skilled in the art. However, these changes or modifications are included in the te~ch~ ng of the disclo-sure, and it is int~n~^~ that the invention be limlted only by the scope of the claims Apr~ d hereto.

Claims

What Is Claimed Is:

1. In an implantable prosthesis adapted for im-plantation in a human, the improvement comprising a tran-sponder mounted thereto so that said transponder is im-planted as said prosthesis is implanted, said transponder having means for being encoded with a unique tag so that said transponder may be readily identified after implan-tation by reading said unique tag.

2. The prosthesis of Claim 1 wherein said tran-sponder has means for its tag to be read with a non-inva-sive protocol.

3. The prosthesis of Claim 2 wherein said tran-sponder has means for its tag to be read electromagneti-cally.

4. The prosthesis of Claim 3 wherein said tran-sponder has means for being energized by a remote reader thereby obviating a need for a battery to be contained in said transponder.

5. The prosthesis of Claim 4 wherein said tran-sponder has means for being encoded with a number select-ed from within a range of 0 to 64 bits, binary.

6. The prosthesis of Claims 5 wherein said prosthe-sis is a breast implant including an envelope.

7. The prosthesis of Claim 6 wherein said tran-sponder is mounted to said implant by being laminated between layers of said envelope.

8. The prosthesis of Claim 7 wherein said implant further comprises a seal patch on said envelope, said transponder being laminated into said seal patch.

9. The prosthesis of Claim 1 wherein said tran-sponder is mounted within the profile of said prosthesis.

10. The prosthesis of Claim 9 wherein said tran-sponder is sealed within a hole in said prosthesis.

11. The prosthesis of Claim 1 wherein said prosthe-sis is a soft tissue implant.

12. The prosthesis of Claim 1 wherein said prosthe-sis is a reconstructive bone implant.

13. The prosthesis of Claim 1 wherein said prosthe-sis is a joint reconstructive implant.

14. The prosthesis of Claim 13 wherein said pros-thesis is a replacement joint.

15. A prosthesis intended for human implantation, said prosthesis including a transponder mounted thereto so that said transponder is implanted as said prosthesis is implanted, said transponder having means for being encoded with a unique identifier so that said trans-ponder's identifier may be read after implantation and associated with a data base for reporting selected data corresponding to said implant.

16. The prosthesis of Claim 15 wherein said tran-sponder has means for its identifier to be read remotely.

17. The prosthesis of Claim 16 wherein said tran-sponder has means for its identifier to be read electro-magnetically.

18. The prosthesis of Claim 17 wherein said tran-sponder has means for being energized by a remote reader thereby obviating a need for a battery to be contained in said transponder.

19. The prosthesis of Claim 18 wherein said pros-thesis is a breast implant comprised of an envelope with a multi-layered seal patch, said transponder being mount-ed therein by being sealed between the layers of said seal patch.

20. The prosthesis of Claim 19 wherein said tran-sponder has means for being encoded with a number select-ed from within the range of 0 to 64 bits, binary.

21. The prosthesis of Claim 15 wherein said tran-sponder is mounted within the profile of said prosthesis.

22. The prosthesis of Claim 21 wherein said tran-sponder is sealed within a hole in said prosthesis.

23. The prosthesis of Claim 15 wherein said pros-thesis is a soft tissue implant.

24. The prosthesis of Claim 15 wherein said pros-thesis is a reconstructive bone implant.

25. The prosthesis of Claim 15 wherein said pros-thesis is a joint reconstructive implant.

26. The prosthesis of Claim 25 wherein said pros-thesis is a replacement joint.

27. A breast implant comprised of an elastomeric shell, a multi-layered elastomeric seal patch adhered to said shell, and an electromagnetically readable trans-ponder laminated between the layers of said seal patch, said transponder having means for being encoded with a unique code so that after implantation said code may be read by a remote, non-invasive reader to thereby learn selected data concerning said implant.