Packaged Systems for Implanting Markers in a Patient and Methods for Manufacturing and Using Such Systems

• US 20080287779A1
• Filed: 06/27/2008
• Published: 11/20/2008
• Est. Priority Date: 12/30/2002
• Status: Active Grant

• Current Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Original Assignee: Calypso Medical Technologies, Inc. (Siemens AG)
• Inventors: Seiler, Keith, Hadford, Eric
• Granted Patent: US 8,011,508 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 2090/3975 active
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/3001 for sharps
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61N 2005/1011 Apparatus for permanent insertion of sources
• CPC Class Codes: A61N 2005/1051 using an active marker markers in general A61B90/39

Abstract

Packaged systems for implanting a marker in a patient and methods for manufacturing and using such systems. In one embodiment, a packaged system comprises an introducer having a cannula and a stylet configured to be received in the cannula, a marker in the cannula, and a package having a sterile compartment. The marker can have a casing configured to be implanted in a patient and a resonating circuit in the casing. The resonating circuit can comprise a coil configured to wirelessly transmit a target signal in response to a wirelessly transmitted excitation signal. The introducer is contained within the sterile compartment. In another embodiment, the marker is not loaded in the introducer within the compartment of the package.

Claims

1. A packaged system for implanting a marker in a patient, comprising:

an introducer having a cannula and a stylet configured to be received in the cannula;

a marker in the cannula, the marker having a casing configured to be implanted in a patient and a resonating circuit in the casing, the resonating circuit comprising a coil configured to wirelessly transmit a target signal in response to a wirelessly transmitted excitation signal; and

a package having a sterile compartment, wherein the introducer is contained within the sterile compartment.

2. The packaged system of claim 1 wherein the marker comprises a first marker and the system further comprises a second marker in the cannula, and wherein the second marker comprises another casing configured to be implanted in the patient and another resonating circuit that wirelessly transmits another target signal in response to another wirelessly transmitted excitation signal.

3. The packaged system of claim 1 wherein:

the marker comprises a first marker, the casing comprises a first casing, and the resonating circuit comprises a first resonating circuit configured to wirelessly transmit a first target signal at a first frequency in response to a first excitation signal; and

the system further comprises a second marker having a second casing and a second resonating circuit in the second casing, the second resonating circuit being configured to wirelessly transmit a second signal at a second frequency in response to a second excitation signal, wherein the first frequency is different than the second frequency.

4. The packaged system of claim 1 wherein the marker is the sole marker in the cannula.

5. The packaged system of claim 1 wherein:

the introducer comprises a first introducer and the marker comprises a first marker, the casing comprises a first casing, and the resonating circuit comprises a first resonating circuit configured to produce a wirelessly transmitted first target signal in response to a first excitation signal; and

the system further comprising a second introducer in the package and a second marker in the second introducer, the second marker comprising a second casing configured to be implanted in the patient and a second resonating circuit in the second casing, and the second resonating circuit being configured to wirelessly transmit a second target signal in response to a second excitation signal.

6. The packaged system of claim 5 wherein the package comprises a tray and a cover sealed to the tray, the tray having a first introducer retainer in which the first introducer is positioned and a second introducer retainer in which the second introducer is positioned.

7. The packaged system of claim 1 wherein:

the introducer comprises a first introducer and the marker comprises a first marker, the casing comprises a first casing, and the resonating circuit comprises a first resonating circuit configured to produce a wirelessly transmitted first target signal at a first frequency in response to a first excitation signal; and

the system further comprising a second introducer in the package and a second marker in the second introducer, the second marker comprising a second casing configured to be implanted in a patient and a second resonating circuit in the second casing, and the second resonating circuit being configured to wirelessly transmit a second target signal at a second frequency in response to a second excitation signal.

8. The packaged system of claim 7 wherein the package comprises a tray and a cover sealed to the tray, the tray having a first introducer retainer in which the first introducer is positioned and a second introducer retainer in which the second introducer is positioned.

9. The packaged system of claim 1 wherein:

the introducer comprises a first introducer and the marker comprises a first marker, the casing comprises a first casing, and the resonating circuit comprises a first resonating circuit configured to produce a wirelessly transmitted first target signal at a first frequency in response to a first excitation signal;

the system further comprising a second introducer in the package and a second marker in the second introducer, the second marker comprising a second casing configured to be implanted in a patient and a second resonating circuit in the second casing, and the second resonating circuit being configured to wirelessly transmit a second target signal at a second frequency in response to a second excitation signal; and

the system further comprising a third introducer in the package and a third marker in the third introducer, the third marker comprising a third casing configured to be implanted in a patient and a third resonating circuit in the third casing, and the third resonating circuit being configured to wirelessly transmit a third target signal at a third frequency in response to a third excitation signal

10. The system of claim 1 wherein the introducer has a lumen, a distal tip, and a projection projecting into the lumen at the distal tip to releasably retain the marker in the lumen during storage.

11. The system of claim 1 wherein:

the introducer further comprises a handle;

the stylet has a proximal section fixed to the handle and a distal section projecting from the handle;

the cannula has a proximal portion and a distal portion, the proximal portion of the cannula being slidably receivable in the handle and slidably positioned over the stylet, and the cannula being slidable through the handle and over the stylet between a storage position in which the distal portion of the cannula extends beyond the stylet and a release position in which at least a length of the distal portion of the cannula is positioned over the stylet; and

the marker is retained in the length of the distal portion of the cannula in the storage position.

12. The system of claim 1 wherein the marker does not have external leads projecting externally of the casing.

13. The system of claim 1 wherein the marker further comprises a capacitor electrically coupled to the coil and a ferromagnetic element positioned at least partially within the coil, and wherein the ferromagnetic element has a diameter not greater than approximately 0.7 mm.

14. The packaged system of claim 1 wherein:

the introducer comprises a first introducer having a first handle, the cannula comprises a first cannula of the first introducer having a portion slidably receivable in the first handle, and the stylet comprises a first stylet of the first introducer fixedly attached to the first handle and slidably received in the first cannula, and the system further comprises a second introducer having a second handle, a second cannula having a portion slidably received in the second handle, and a second stylet fixedly attached to the second handle and slidably received in the second cannula;

the marker comprises a first marker in the first cannula of the first introducer, the first marker having a first resonating circuit configured to produce a wirelessly transmitted first target signal at a first frequency in response to a first excitation signal; and

the system further comprises a second marker in the second cannula of the second introducer, the second marker comprising a second resonating circuit configured to wirelessly transmit a second target signal at a second frequency in response to a second excitation signal.

15. A packaged system for implanting markers in a patient, comprising:

a plurality of introducers including a first introducer having a first cannula and a first stylet configured to be received in the first cannula, and a second introducer having a second cannula and a second stylet configured to be received in the second cannula;

a first marker in the first cannula, the first marker having a first casing configured to be implanted in a patient and a first resonating circuit in the first casing, and the first resonating circuit being configured to be energized by a wirelessly transmitted first excitation signal and produce a wirelessly transmitted first target signal in response to the first excitation signal;

a second marker in the second cannula, the second marker having a second casing configured to be implanted in the patient and a second resonating circuit in the second casing, and the second resonating circuit being configured to be energized by a wirelessly transmitted second excitation signal and produce a wirelessly transmitted second target signal in response to the second excitation signal; and

a package having a sterile compartment, wherein the first and second introducers are contained in the sterile compartment.

16. The packaged system of claim 15 wherein the package comprises a tray and a cover sealed to the tray, the tray having a first introducer retainer in which the first introducer is positioned and a second introducer retainer in which the second introducer is positioned.

17. The system of claim 15 wherein the first introducer has a lumen, a distal tip, and a projection projecting into the lumen at the distal tip to releasably retain the first marker in the lumen during storage.

18. The system of claim 15 wherein:

the first introducer further comprises a handle;

the first stylet has a proximal section fixed to the handle and a distal section projecting from the handle;

the first cannula has a proximal portion and a distal portion, the proximal portion of the first cannula being slidably receivable in the handle and slidably positioned over the first stylet, the first cannula being slidable through the handle and over the first stylet between a storage position in which the distal portion of the first cannula extends beyond the first stylet and a release position in which at least a length of the distal portion of the first cannula is over the first stylet; and

the first marker is retained in the length of the distal portion of the first cannula in the storage position.

19. The packaged system of claim 15 wherein the first target signal has a first frequency and the second target signal has a second frequency different than the first frequency.

20. The system of claim 15 wherein the first marker further comprises a capacitor electrically coupled to the coil and a ferromagnetic element positioned at least partially within the coil, and wherein the ferromagnetic element has a diameter not greater than approximately 0.7 mm.

21. A packaged system for implanting markers in a patient, comprising:

an introducer having a cannula and a stylet configured to be received in the cannula;

a plurality of markers in the cannula, the markers including a first marker having a first casing configured to be implanted in a patient and a first resonating circuit in the first casing, the first resonating circuit comprising a first coil configured to wirelessly transmit a first target signal in response to a wirelessly transmitted first excitation signal, and the markers including a second marker having a second casing configured to be implanted in the patient and a second resonating circuit in the second casing, the second resonating circuit comprising a second coil configured to wirelessly transmit a second target signal in response to a wirelessly transmitted second excitation signal;

a spacer in the cannula between the first marker and the second marker; and

a package having a sterile compartment, wherein the introducer is contained in the sterile compartment.

22. The packaged system of claim 21, wherein the first target signal has a first frequency and the second target signal has a second frequency different than the first frequency.

23. The packaged system of claim 21, further comprising a second introducer in the package and a third marker in the second introducer, the third marker comprising a third casing and a third resonating circuit in the third casing, the third resonating circuit comprising a third coil configured to wirelessly transmit a third target signal in response to a wirelessly transmitted third excitation signal.

24. The packaged system of claim 21 wherein the package comprises a tray and a cover sealed to the tray, the tray having an introducer retainer in which the first introducer is positioned.

25. The system of claim 21 wherein:

the introducer further comprises a handle;

the stylet has a proximal section fixed to the handle and a distal section projecting from the handle;

the cannula has a proximal portion and a distal portion, the proximal portion of the cannula being slidably receivable in the handle and slidably positioned over the stylet, and the cannula being slidable through the handle and over the stylet between a storage position in which the distal portion of the cannula extends beyond the stylet and a release position in which at least a length of the distal portion of the cannula is over the stylet; and

the first and second markers are retained in the length of the distal portion of the cannula in the storage position.

26. The system of claim 21 wherein the first and second markers do not have external leads projecting externally of the casing.

27. The system of claim 21 wherein the first marker further comprises a capacitor electrically coupled to the first coil and a ferromagnetic element positioned at least partially within the first coil, and wherein the ferromagnetic element has a diameter not greater than approximately 0.7 mm.

28-29. -29. (canceled)

31. In localization systems that involve implanting markers in a patent, a method for manufacturing a packaged system for implanting a marker in a patient, comprising:

providing a first marker having a first casing configured to be implanted in a patient and a first resonating circuit in the first casing, wherein the first resonating circuit comprises a first coil configured to wirelessly transmit a first target signal in response to a wirelessly transmitted first excitation signal;

preloading the first marker into a first cannula of a first introducer; and

sealing the first introducer with the first marker in the first cannula in a compartment of a package.

32. The method of claim 31, further comprising:

providing a second marker having a second casing configured to be implanted in the patient and a second resonating circuit in the second casing, wherein the second resonating circuit comprises a second coil configured to wirelessly transmit a second target signal in response to a wirelessly transmitted second excitation signal; and

preloading the second marker into the first cannula of the first introducer before sealing the first introducer in the compartment of the package.

33. The method of claim 32 wherein providing the first marker comprises configuring the first resonating circuit to have a first frequency, and providing the second marker comprises configuring the second resonating circuit to have a second frequency different than the first frequency.

34. The method of claim 32 wherein providing the first marker comprises configuring the first resonating circuit to have a first frequency, and providing the second marker comprises configuring the second resonating circuit to have the first frequency.

35. The method of claim 32, further comprising placing a spacer in the cannula between the first and second markers.

36. The method of claim 31, further comprising:

providing a second marker having a second casing configured to be implanted in the patient and a second resonating circuit in the second casing, wherein the second resonating circuit comprises a second coil configured to wirelessly transmit a second target signal in response to a wirelessly transmitted second excitation signal; and

preloading the second marker into a second cannula of a second introducer; and

sealing the second introducer in the compartment of the package with the first introducer.

37. The method of claim 36 wherein providing the first marker comprises configuring the first resonating circuit to have a first frequency, and providing the second marker comprises configuring the second resonating circuit to have a second frequency different than the first frequency.

38. The method of claim 36 wherein providing the first marker comprises configuring the first resonating circuit to have a first frequency, and providing the second marker comprises configuring the second resonating circuit to have the first frequency.

39. The method of claim 36, further comprising placing a spacer in the cannula between the first and second markers.

40. In localization systems for determining the location of a target site in a patient, a method for manufacturing and handling a packaged system for implanting a marker in the patient, comprising:

providing a first marker having a first casing configured to be implanted in a patient and a first resonating circuit in the first casing, wherein the first resonating circuit comprises a first coil configured to wirelessly transmit a first target signal in response to a wirelessly transmitted first excitation signal;

preloading the first marker into a first cannula of a first introducer;

sealing the first introducer with the first marker in the first cannula in a compartment of a package; and

transporting the first introducer with the first marker in the first cannula in the compartment of the package to a customer.