U.S. patent application number 09/430208 was filed with the patent office on 2001-11-29 for apparatus and method for automated invoicing of medical device systems.
Invention is credited to LINBERG, KURT R..
Application Number | 20010047314 09/430208 |
Document ID | / |
Family ID | 23706525 |
Filed Date | 2001-11-29 |
United States Patent
Application |
20010047314 |
Kind Code |
A1 |
LINBERG, KURT R. |
November 29, 2001 |
APPARATUS AND METHOD FOR AUTOMATED INVOICING OF MEDICAL DEVICE
SYSTEMS
Abstract
A system and method for remote invoicing and inventory control
of medical components of an implantable medical device system upon
implantation into a patient is described. The system includes at
least one medical component implanted in a patient. A programmer is
capable of identifying each medical component implanted in the
patient. A remote expert data center globally accessible to the
programmer is connected to the programmer via an interface. An
invoice module positioned on the remote expert data center receives
information identifying each medical component implanted in the
patient and prepares an invoice including each medical component
implanted into the patient. An inventory module updates records
regarding inventory of each implanted medical component.
Inventors: |
LINBERG, KURT R.; (EDEN
PRAIRIE, MN) |
Correspondence
Address: |
GIRMA WOLDE MICHAEL
MEDTRONIC INC
7000 CENTRAL AVENUE NE
MINNEAPOLIS
MN
55432
|
Family ID: |
23706525 |
Appl. No.: |
09/430208 |
Filed: |
October 29, 1999 |
Current U.S.
Class: |
705/28 |
Current CPC
Class: |
G16H 40/67 20180101;
Y10S 128/904 20130101; G16Z 99/00 20190201; Y10S 128/903 20130101;
G16H 40/63 20180101; G06Q 10/087 20130101 |
Class at
Publication: |
705/28 |
International
Class: |
G06F 017/60 |
Claims
What is claimed is:
1. In a bi-directional remote communication system wherein a
web-based remote expert data center is linked in remote
communications with a programmer, the programmer being associated
with at least one IMD, a system for remote invoicing of a medical
component used in the implantable medical device upon implantation
in a patient, the remote invoicing system comprising: at least one
medical component used in conjunction with the implantable medical
device system implanted into the patient; a programmer capable of
identifying each medical component implanted in the patient; a
remote expert data center positioned at a distal location relative
to the programmer; an interface between the programmer and the
remote expert data center; and an invoice preparation module in
data communication with the remote expert data center for receiving
information identifying each medical component implanted in the
patient and for preparing an invoice itemizing each medical
component implanted in the patient.
2. The system of claim 1, wherein the medical component further
comprises an implantable medical device.
3. The system of claim 2, wherein the implantable medical device
further comprises a pacemaker.
4. The system of claim 2, wherein the implantable medical device
further comprises a defibrillator.
5. The system of claim 1, wherein the medical component further
comprises at least one lead used to connect an implantable medical
device to the patient.
6. The system of claim 1, wherein the interface between the
programmer and the remote expert data center further comprises a
local area network communications link.
7. The system of claim 1, wherein the interface between the
programmer and the remote expert data center further comprises an
internet communications link.
8. The system of claim 1, wherein the interface between the
programmer and the remote expert data center further comprises a
telephone line communications link.
9. The system of claim 1, wherein the interface between the
programmer and the remote expert data center further comprises a
satellite communications link.
10. The system of claim 1, wherein the interface between the
programmer and the remote expert data center further comprises a
global positioning system communications link.
11. The system of claim 1, wherein the interface between the
programmer and the remote expert data center further comprises at
least two communication links selected from the group of
communication links consisting of a local area network link, an
internet link, a telephone line link, a satellite link, a global
positioning system link, and a combination thereof.
12. The system of claim 1, wherein the invoice preparation module
receives bar code information identifying the medical component
implanted into the patient.
13. The system of claim 1, wherein the invoice preparation module
receives serial number information identifying the medical
component implanted into the patient.
14. The system of claim 1, wherein the invoice preparation module
receives model number information identifying the medical component
implanted into the patient.
15. The system of claim 1, and further comprising: an interface
between the remote expert data center and a medical facility where
the medical component is implanted into the patient for
transmitting the invoice to the medical facility.
16. A system for maintaining inventory of a medical component of an
implantable medical device system upon implantation in a patient,
the system comprising: at least one medical component used in
conjunction with the implantable medical device system implanted in
the patient; a programmer capable of identifying each medical
component implanted in the patient; a remote expert data center
positioned globally at a distal location relative to the
programmer; an interface between the programmer and the remote
expert data center; and an inventory control module in data
communication with the remote expert data center for receiving
information identifying each medical component implanted in the
patient and for updating an inventory module regarding inventory of
each medical component implanted in the patient.
17. The system of claim 16, wherein the medical component further
comprises an implantable medical device.
18. The system of claim 17, wherein the implantable medical device
further comprises a pacemaker.
19. The system of claim 17, wherein the implantable medical device
further comprises a defibrillator.
20. The system of claim 16, wherein the medical component further
comprises at least one lead used to connect an implantable medical
device to the patient.
21. The system of claim 16, wherein the interface between the
programmer and the remote expert data center further comprises a
local area network communications link.
22. The system of claim 16, wherein the interface between the
programmer and the remote expert data center further comprises an
internet communications link.
23. The system of claim 16, wherein the interface between the
programmer and the remote expert data center further comprises a
telephone line communications link.
24. The system of claim 17, wherein the interface between the
programmer and the remote expert data center further comprises a
satellite communications link.
25. The system of claim 17, wherein the interface between the
programmer and the remote expert data center further comprises a
global positioning system communications link.
26. The system of claim 17, wherein the interface between the
programmer and the remote expert data center further comprises at
least two communication links selected from the group of
communication links consisting of a local area network link, an
internet link, a telephone line link, a satellite link, a global
positioning system link, and a combination thereof.
27. The system of claim 16, wherein the inventory control module
receives bar coded information identifying the medical component
implanted into the patient.
28. The system of claim 16, wherein the inventory control module
receives serial number information identifying the medical
component implanted into the patient.
29. The system of claim 16, wherein the inventory control module
receives model number information identifying the medical component
implanted into the patient.
30. A method of remote invoicing of a medical component of an
implantable medical device system upon implantation in a patient,
the method comprising the steps of: initiating an interface between
the implantable medical device system and an a remote expert data
center located at a distal location relative the implantable
medical device system; transmitting information identifying the
medical component implanted in the patient to the remote expert
data center; and preparing an invoice for the medical component in
the remote expert data center based upon the transmitted
information identifying the medical component.
31. The method of claim 30, wherein the step of transmitting
information includes the further step of: transmitting bar code
information identifying the medical component implanted in the
patient to the remote expert data center.
32. The method of claim 30, wherein the step of transmitting
information includes the further step of: transmitting serial
number information identifying the medical component implanted in
the patient to the remote expert data center.
33. The method of claim 30, wherein the step of transmitting
information includes the further step of: transmitting model number
information identifying the medical component implanted in the
patient to the remote expert data center.
34. The method of claim 30, and further including the step of
comprising: transmitting location information regarding a location
of the implant procedure to the remote expert data center.
35. The method of claim 30, and further including the step of
comprising: transmitting operator information regarding an
implanting physician to the remote expert data center.
36. The method of claim 30, and further including the step of
comprising: transmitting timing information regarding a date and
time of the implantation of the implantable medical device system
to the remote expert data center.
37. The method of claim 30, and further including the step of
comprising: transmitting an itemized bill to a medical facility
where the implantation of the medical component occurred.
38. The method of claim 30, wherein the step of initiating an
interface further including the step of comprises: initiating a
local area network communications link between the implantable
medical device system and the remote expert data center.
39. The method of claim 30, wherein the step of initiating an
interface further including the step of comprises: initiating an
internet communications link between the implantable medical device
system and the remote expert data center.
40. The method of claim 30, wherein the step of initiating an
interface further including the step of comprises: initiating a
telephone line communications link between the implantable medical
device system and the remote expert data center.
41. The method of claim 30, wherein the step of initiating an
interface further including the step of comprises: initiating a
satellite communications link between the implantable medical
device system and the remote expert data center.
42. The method of claim 30, wherein the step of initiating an
interface further including the step of comprises: initiating a
global positioning system communications link between the
implantable medical device system and the remote expert data
center.
43. The method of claim 30, wherein the step of initiating an
interface further including the step of comprises: initiating at
least two communications link between the programmer and the remote
expert data center links selected from the group of communication
links consisting of a local area network link, an internet link, a
telephone line link, a satellite link, a global positioning system
link, and a combination thereof.
44. A method of remotely controlling inventory of a medical
component of an implantable medical device system upon implantation
into a patient, the method comprising: initiating an interface
between the implantable medical device system and a remote expert
data center located at a distal location relative to the
implantable medical device system; transmitting information
identifying the medical component implanted into the patient to the
remote expert data center; and updating the inventory of the
medical component in the remote expert data center based upon the
information identifying of the medical component.
45. The method of claim 44, wherein the step of transmitting
information includes the further step of: transmitting bar code
information identifying the medical component implanted in the
patient to the remote expert data center.
46. The method of claim 44, wherein the step of transmitting
information includes the further step of: transmitting serial
number information identifying the medical component implanted in
the patient to the remote expert data center.
47. The method of claim 44, wherein the step of transmitting
information includes the further step of: transmitting model number
information identifying the medical component implanted in the
patient to the remote expert data center.
48. The method of claim 44, and further including the step of:
transmitting location information regarding the location of the
implant procedure to the remote expert data center.
49. The method of claim 44, and further including the step of:
transmitting operator information regarding an implanting physician
to the remote expert data center.
50. The method of claim 44, and further including the step of:
transmitting timing information regarding a date and a time of the
implantation of the implantable medical device system to the remote
expert data center.
51. The method of claim 46, and further including the step of:
transmitting the identifying information to an inventory management
system; and controlling inventory of the medical component at the
location of the implantation.
52. The method of claim 44, wherein the step of initiating an
interface further including the step of: initiating a local area
network communications link between the implantable medical device
system and the remote expert data center.
53. The method of claim 44, wherein the step of initiating an
interface further including the step of: initiating an internet
communications link between the implantable medical device system
and the remote expert data center.
54. The method of claim 44, wherein the step of initiating an
interface further including the step of: initiating a telephone
line communications link between the implantable medical device
system and the remote expert data center.
55. The method of claim 44, wherein the step of initiating an
interface further including the step of: initiating a satellite
communications link between the implantable medical device system
and the remote expert data center.
56. The method of claim 44, wherein the step of initiating an
interface further including the step of: initiating a global
positioning system communications link between the implantable
medical device system and the remote expert data center.
57. The method of claim 44, wherein the step of initiating an
interface further including the step of: initiating at least two
communication links between the programmer and the remote expert
data center selected from the group of communication links
consisting of a local area network link, an internet link, a
telephone line link, a satellite link, a global positioning system
link, and a combination thereof.
58. A system for remote invoicing of a medical component used in of
an implantable medical device system upon implantation in a
patient, the system comprising: means for initiating an interface
between the implantable medical device system and a remote expert
data center located at a distal location relative to the
implantable medical device system; means for transmitting
information identifying the medical component implanted into the
patient to the remote expert data center; and means for preparing
an invoice for the medical component in the remote expert data
center based upon the information identifying the medical
component.
59. A system for remotely controlling inventory of a medical
component of an implantable medical device system upon implantation
in a patient, the system comprising: means for initiating an
interface between the implantable medical device system and a
remote expert data center globally located at a distal location
relative to the implantable medical device system; means for
transmitting information identifying the medical component
implanted into the patient to the remote expert data center; and
means for updating the inventory of the medical component in the
remote expert data center based upon the information identifying of
the medical component.
Description
THE FIELD OF THE INVENTION
[0001] The present invention relates generally to medical device
systems. Specifically, the invention pertains to a remote
bi-directional communications with one or more programmable
devices, that are associated with implantable medical devices.
Generally, the invention relates to an integrated system and method
of bi-directional telecommunications between a web-based expert
data center and at least one programmer, utilizing various types of
network platforms and architecture to implement, in the programmer,
distance-based troubleshooting, maintenance, upgrade, information
and administrative services thereby providing an economical and
highly interactive system for therapy and clinical care. More
specifically, the present invention provides an automatic invoice
of medical components used in conjunction with an implantable
medical device systems.
BACKGROUND OF THE INVENTION
[0002] A technology-based health care system that fully integrates
the technical and social aspects of patient care and therapy should
be able to flawlessly connect the client with care providers
irrespective of separation distance or location of the
participants. While clinicians will continue to treat patients in
accordance with accepted modern medical practice, developments in
communications technology are making it ever more possible to
provide medical services in a time and place independent
manner.
[0003] Prior art methods of clinical services are generally limited
to in-hospital operations. For example, if a physician needs to
review the performance parameters of an implantable device in a
patient, it is likely that the patient has to go to the clinic.
Further, if the medical conditions of a patient with an implantable
device warrant a continuous monitoring or adjustment of the device,
the patient would have to stay in a hospital indefinitely. Such a
continued treatment plan poses both economic and social problems.
Under the exemplary scenario, as the segment of the population with
implanted medical devices increases many more hospitals /clinics
including service personnel will be needed to provide in-hospital
service for the patients, thus escalating the cost of healthcare.
Additionally the patients will be unduly restricted and
inconvenienced by the need to either stay in the hospital or make
very frequent visits to a clinic.
[0004] Yet another condition of the prior art practice requires
that a patient visit a clinical center for occasional retrieval of
data from the implanted device to assess the operations of the
device and gather patient history for both clinical and research
purposes. Such data is acquired by having the patient in a
hospital/clinic to down load the stored data from the implantable
medical device. Depending on the frequency of data collection this
procedure may pose a serious difficulty and inconvenience for
patients who live in rural areas or have limited mobility.
Similarly, in the event a need arises to upgrade the software of an
implantable medical device, the patient will be required to come
into the clinic or hospital to have the upgrade installed. Further,
in medical practice it is an industry-wide standard to keep an
accurate record of past and present procedures relating to an IMD.
Generally, a report should be generated each time a medical
component such as a programmer and/or analyzer is connected to the
IMD. Various information should be contained in the report
including an identification of all the medical components used
during a procedure. Specifically, all peripheral and major devices
that are used in down linking to the IMD need to be reported.
Presently, there is no automated system for providing an automated
report of all the major components used in a procedure involving
communications with an IMD. The current practice is for a medical
person to physically record or enter data related to the devices
used in the down linking procedure. One of the limitations of this
procedure is the fact that is error prone and often requires
rechecking of the data to verify accuracy. Further, the current
method does not lend itself to a centralized network where
identification and related data, for globally distributed
programmers and peripheral devices used in conjunction with IMDS,
could be stored.
[0005] A further limitation of the prior art relates to the
management of multiple implantable devices in a single patient.
Advances in modern patient therapy and treatment have made it
possible to implant a number of devices in a patient. For example,
implantable devices such as a defibrillator or a pacer, a neural
implant, a drug pump, a separate physiologic monitor and various
other implantable devices may be implanted in a single patient. To
successfully manage the operations and assess the performance of
each device in a patient with multi-implants requires a continuous
update and monitoring of the devices. Further, it may be preferred
to have an operable communication between the various implants to
provide a coordinated clinical therapy to the patient. Thus, there
is a need to monitor the performance of the implantable devices on
a regular, if not a continuous, basis to ensure optimal patient
care. In the absence of other alternatives, this imposes a great
burden on the patient if a hospital or clinic is the only center
where the necessary frequent follow up, evaluation and adjustment
of the medical devices could be made. Moreover, even if feasible
the situation would require the establishment of multiple service
areas or clinic centers to provide adequate service to the
burgeoning number of multi-implant patients worldwide. Accordingly,
it is vital to have a programmer unit that would connect to a
remote expert medical center to provide access to expert systems
and import the expertise to a local environment. This approach
would enable unencumbered access to the IMD or the patient.
Further, the proliferation of patients with multi-implant medical
devices worldwide has made it imperative to provide remote
services. Thus, frequent use of programmers to communicate with the
IMD and provide various remote services, consistent with the
disclosure contained in co-pending applications titled "Apparatus
and Method for Remote Troubleshooting, Maintenance and Upgrade of
Implantable Device Systems," filed on Oct. 26, 1999, which is
incorporated by reference herein in its entirety, has become an
important aspect of patient care.
[0006] The prior art provides various types of remote sensing and
communications with an implanted medical device. One such system
is, for example, disclosed in Funke, U.S. Pat. No. 4,987,897 issued
Jan. 29, 1991. This patent discloses a system that is at least
partially implanted into a living body with a minimum of two
implanted devices interconnected by a communication transmission
channel. The invention further discloses wireless communications
between an external medical device/programmer and the implanted
devices.
[0007] One of the limitations of the system disclosed in the Funke
patent includes the lack of communication between the implanted
devices, including the programmer, with a remote clinical station.
If, for example, any assessment, monitoring or maintenance is
required to be performed on the IMD the patient will have to go to
the remote clinic station or the programmer device needs to be
brought to the patient's location. More significantly, the
operational worthiness and integrity of the programmer cannot be
evaluated remotely thus making it unreliable over time as it
interacts with the IMD.
[0008] Yet another example of sensing and communications system
with a plurality of interactive implantable devices is disclosed by
Stranberg in U.S. Pat. No. 4,886,064, issued Dec. 12, 1989. In this
disclosure, body activity sensors, such as temperature, motion,
respiration and/or blood oxygen sensors, are positioned in a
patient's body outside a pacer capsule. The sensors wirelessly
transmit body activity signals, which are processed by circuitry in
the heart pacer. The heart pacing functions are influenced by the
processed signals. The signal transmission is a two-way network and
allows the sensors to receive control signals for altering the
sensor characteristics.
[0009] One of the many limitations of Stranberg is the fact that
although there is corporeal two-way communications between the
implantable medical devices, and the functional response of the
heart pacer is processed in the pacer after collecting input from
the other sensors, the processor is not remotely programmable.
Specifically, the system does not lend itself to web-based
communications to enable remote troubleshooting, maintenance and
upgrade from outside the patient's body because the
processor/programmer is internally located in the patient forming
an integral part of the heart pacer.
[0010] Yet another prior art reference provides a multi-module
medication delivery system as disclosed by Fischell in U.S Pat. No.
4,494,950 issued Jan. 22, 1985. The disclosure relates to a system
consisting a multiplicity of separate modules that collectively
perform a useful biomedical purpose. The modules communicate with
each other without the use of interconnecting wires. All the
modules may be installed intracorporeal or mounted extracorporeal
to the patient. In the alternate, some modules may be
intracorporeal with others being extracorporeal. Signals are sent
from one module to the other by electromagnetic waves. Physiologic
sensor measurements sent from a first module cause a second module
to perform some function in a closed loop manner. One
extracorporeal module can provide electrical power to an
intracorporeal module to operate a data transfer unit for
transferring data to the external module.
[0011] The Fischell disclosure provides modular communication and
cooperation between various medication delivery systems. However,
the disclosure does not provide an external programmer with remote
sensing, remote data management and maintenance of the modules.
Further, the system does neither teach nor disclose an external
programmer for telemetrically programming the modules.
[0012] Yet another example of remote monitoring of implanted
cardioverter defibrillators is disclosed by Gessman in U.S. Pat.
No. 5,321,618 issued. In this disclosure a remote apparatus is
adapted to receive commands from and transmit data to a central
monitoring facility over telephone communication channels. The
remote apparatus includes equipment for acquiring a patient's ECG
waveform and transmitting that waveform to the central facility
over the telephone communications channels. The remote apparatus
also includes a segment, responsive to a command received from the
central monitoring facility, for enabling the emission of audio
tone signals from the cardioverter defibrillator. The audio tones
are detected and sent to the central monitoring facility via the
telephone communication channel. The remote apparatus also includes
patient alert devices, which are activated by commands received
from the central monitoring facility over the telephone
communication channel.
[0013] One of the many limitations of the apparatus and method
disclosed in the Gessman patent is the fact that the segment, which
may be construed to be equivalent to a programmer, is not remotely
adjustable from the central monitoring device. The segment merely
acts as a switching station between the remote apparatus and the
central monitoring station.
[0014] An additional example of prior art practice includes a
packet-based telemedicine system for communicating information
between central monitoring stations and a remote patient monitoring
station disclosed in Peifer, WO 99/14882 published Mar. 25, 1999.
The disclosure relates to a packet-based telemedicine system for
communicating video, voice and medical data between a central
monitoring station and a patient that is remotely located with
respect to the central monitoring station. The patient monitoring
station obtains digital video, voice and medical measurement data
from a patient and encapsulates the data in packets and sends the
packets over a network to the central monitoring station. Since the
information is encapsulated in packets, the information can be sent
over multiple types or combination of network architectures,
including a community access television (CATV) network, the public
switched telephone network (PSTN), the integrated services digital
network (ISDN), the Internet, a local area network (LAN), a wide
area network (WAN), over a wireless communications network, or over
asynchronous transfer mode (ATM) network. A separate transmission
code is not required for each different type of transmission
media.
[0015] One of the advantages of the Pfeifer invention is that it
enables data of various forms to be formatted in a single packet
irrespective of the origin or medium of transmission. However, the
data transfer system lacks the capability to remotely debug the
performance parameters of the medical interface device or the
programmer. Further, Pfeifer does not disclose a method or
structure by which the devices at the patient monitoring station
may be remotely updated, maintained and tuned to enhance
performance or correct errors and defects.
[0016] Another example of a telemetry system for implantable
medical devices is disclosed in Duffin et al, U.S. Pat. No.
5,752,976, issued May 19, 1998, incorporated by reference herein in
its entirety. Generally, the Duffin et al disclosure relates to a
system and method for communicating with a medical device implanted
in an ambulatory patient and for locating the patient in order to
selectively monitor device function from a remote medical support
network. The communications link between the medical support
network and the patient communications control device may comprise
a world wide satellite network, a cellular telephone network or
other personal communications system.
[0017] Although the Duffin et al disclosure provides significant
advances over the prior art, it does not teach a communications
scheme in which a programmer is remotely debugged, maintained,
upgraded or modified to ultimately enhance the support it provides
to the implantable device with which it is associated.
Specifically, the Duffin et al disclosure is limited to notifying
remote medical support personnel or an operator about impending
problems with an IMD and also enables constant monitoring of the
patient's position worldwide using the GPS system. However, Duffin
et al does not teach the remote programming scheme contemplated by
the present invention.
[0018] In a related art, Thompson discloses a patient tracking
system in a co-pending application entitled "World-wide Patient
Location and Data Telemetry System For Implantable Medical
Devices", Ser. No. 09/045,272, filed on Mar. 20, 1998 which is
incorporated by reference herein in its entirety. The disclosure
provides additional features for patient tracking in a mobile
environment worldwide via the GPS system. However, the remote
programming concepts advanced by the present invention are not
within the purview of the Thompson disclosure because there is no
teaching of a web-based environment in which a programmer is
remotely evaluated and monitored to effect functional and
parametric tune up, upgrade and maintenance as needed. Further in
Thompson, the components of the programmer cannot be interrogated
for remote identification.
[0019] Yet in another related art, Ferek-Petric discloses a system
for communication with a medical device in a co-pending
application, Ser. No. 09/348,506 which is incorporated by reference
herein in its entirety. The disclosure relates to a system that
enables remote communications with a medical device, such as a
programmer. Particularly, the system enables remote communications
to inform device experts about programmer status and problems, The
experts will then provide guidance and support to the remotely to
service personnel or operators located at the programmer. The
system may include a medical device adapted to be implanted into a
patient; a server PC communicating with the medical device; the
server PC having means for receiving data transmitted across a
dispersed data communication pathway, such as the Internet; and a
client PC having means for receiving data transmitted across a
dispersed communications pathway from the SPC. In certain
configurations the server PC may have means for transmitting data
across a dispersed data communication pathway (Internet) along a
first channel and a second channel; and the client PC may have
means for receiving data across a dispersed communication pathway
from the server PC along a first channel and a second channel.
[0020] One of the significant teachings of Ferek-Petric's
disclosure, in the context of the present invention, includes the
implementation of communication systems, associated with IMDs that
are compatible with the Internet. Specifically the disclosure
advances the art of remote communications between a medical device,
such as a programmer, and experts located at a remote location
using the Internet. As indicated hereinabove, the communications
scheme is structured to primarily alert remote experts to existing
or impending problems with the programming device so that prudent
action, such as early maintenance or other remedial steps, may be
timely exercised. Further, because of the early warning or advance
knowledge of the problem, the remote expert would be well informed
to provide remote advice or guidance to service personnel or
operators at the programmer.
[0021] While Ferek-Petric's invention advances the art in
communications systems relating to interacting with a programmer
via a communication medium such as the Internet, the system does
neither propose nor suggest remote programming, debugging and
maintenance of a programmer without the intervention of a service
person. Further, Ferek-Petric's disclosure does not disclose a
remote interrogation scheme to identify components used in a
programmer-IMD interaction procedure.
[0022] Specifically, generating an invoice for components implanted
in a patient and maintaining and controlling inventory for
implantable components are critical issues for the medical device
industry. For example, at any one time, millions of dollars of
medical components associated with an implantable medical system
have been implanted into a patient. However, there is often a time
delay between the implant procedure and both the billing for the
implanted components and the inventoring of the implanted
components.
[0023] Presently, once an implant procedure of a medical device is
completed, various procedures must occur regarding inventory
control and billing for the implanted components. First, a member
of the hospital or medical facility where the implant procedure
took place must notify a representative of the company that sold
the medical components to the hospital or medical facility that an
implant procedure has occurred. The medical facility member will
indicate that specific medical components, such as pacing and/or
sensing leads and a pacemaker, have been implanted into a patient.
The notification is normally done by preparing paperwork regarding
the implanted components and forwarding the paperwork to the
representative. The representative must fill out additional paper
work regarding the medical components which were implanted and
forward the paperwork to a central location. An invoice is prepared
at the central location itemizing the implanted medical components,
and the hospital or medical facility where the implant procedure
occurred is billed accordingly. The information regarding the
implant procedure is also forwarded to an inventory department of
the company so that the quantity of medical components at a
specific hospital or medical facility can be monitored and
controlled. This entire process may take weeks or even months to be
completed.
[0024] The above-discussed procedure for preparing an invoice and
for controlling inventory is both time consuming and expensive.
Therefore, there is a need for a procedure which will properly
control inventory and invoicing of medical components associated
with an implant procedure.
[0025] Accordingly it would be advantageous to provide a system in
which a programmer could uplink to a remote expert data center to
import enabling software for self-diagnosis, maintenance and
upgrade of the programmer. Yet another desirable advantage would be
to provide a system to implement the use of remote expert systems
to manage a programmer on a real-time basis. A further desirable
advantage would be to provide a communications scheme that is
compatible with various communications media, to promote a fast
uplink of a programmer to remote expert systems and specialized
data resources. Yet another desirable advantage would be to provide
a high speed communications scheme to enable the transmission of
high fidelity sound, video and data to advance and implement
efficient remote data management of a clinical/therapy system via a
programmer thereby enhancing patient clinical care. As discussed
herein below, the present invention provides these and other
desirable advantages.
SUMMARY OF THE INVENTION
[0026] The present invention overcomes the disadvantages and
limitations of the prior art by providing a method and apparatus
for remote invoicing of a medical component used in conjunction
with an implantable medical device system in a patient.
[0027] The present invention generally relates to a communications
scheme in which a remote web-based expert data center interacts
with a patient having one or more implantable medical devices
(IMDs) via an associated external medical device, preferably a
programmer, located in close proximity to the IMDs. Some of the
most significant advantages of the invention include the use of
various communications media between the remote web-based expert
data center and the programmer to remotely exchange clinically
significant information including identification of specific
components of the programmer.
[0028] In the context of the present invention, one of the many
aspects of the invention includes a real-time access of a
programmer to a remote web-based expert data center, via a
communication network, which includes the Internet. The operative
structure of the invention includes the remote web-based expert
data center, in which an expert system is maintained, having a
bi-directional real-time data, sound and video communications with
the programmer via a broad range of communication link systems. The
programmer is in turn in telemetric communications with the IMDs
such that the IMDs may uplink to the programmer or the programmer
may down link to the IMDs, as needed.
[0029] In yet another context of the invention, the critical
components and embedded systems of the programmer are remotely
identified, maintained, debugged and/or evaluated to ensure proper
functionality and performance by down linking expert systems and
compatible software from the web-based expert data center.
[0030] In a further context of the invention, a programmer is
remotely identified monitored, assessed and upgraded as needed by
importing expert systems from a remote expert data center via a
wireless or equivalent communications system. The operational and
functional software of the embedded systems in the programmer may
be remotely adjusted, upgraded or changed as apparent. Some of the
software changes may ultimately be implemented in the IMDs as
needed by down linking from the programmer to the IMDs. Further,
specific components used in programmer-IMD interface will be
identified and documented to comply with medical standards.
[0031] Yet another context of the invention includes a
communications scheme that provides a highly integrated and
efficient method and structure of clinical information management
in which various networks such as Community access Television,
Local area Network (LAN), a wide area network (WAN) Integrated
Services Digital Network (ISDN), the Public Switched telephone
Network (PSTN), the Internet, a wireless network, an asynchronous
transfer mode (ATM) network, a laser wave network, satellite,
mobile and other similar networks are implemented to transfer
voice, data and video between the remote data center and a
programmer. In the preferred embodiment, wireless communications
systems, a modem and laser wave systems are illustrated as examples
only and should be viewed without limiting the invention to these
types of communications alone. Further, in the interest of
simplicity, the applicants refer to the various communications
system, in relevant parts, as a communication systems. However, it
should be noted that the communication systems, in the context of
this invention, are interchangeable and may relate to various
schemes of cable, fiber optics, microwave, radio, laser and similar
communications or any practical combinations thereof.
[0032] Some of the distinguishing features of the present invention
include the use of a robust web-based expert data center to manage
the programmer-IMD events and identify the programmer components
used therein and tune the operational and functional parameters of
a programmer in real-time. Specifically, the invention enables
remote diagnosis, maintenance, upgrade, performance tracking,
tuning and adjustment of a programmer from a remote location.
Although the present invention focuses on the remote real-time
monitoring and management of the programmer, some of the changes
and upgrades made to the programmer could advantageously be
transferred to the IMDs. This is partly because some of the
performance parameters of the programmer are functionally parallel
to those in the IMDs. Thus, one additional benefit of the present
invention is an enhancement of the programmer may be implemented,
on a proactive basis, in the IMDs by down linking from the
programmer thereby upgrading the IMDs to promote the patient's well
being.
[0033] Yet one of the other distinguishing features of the
invention includes the use a highly flexible and adaptable
communications scheme to promote continuous and real-time
communications between a remote expert data center and a programmer
associated with a plurality of IMDs. The IMDs are structured to
share information intracorporeally and may interact with the
programmer, as a unit. Specifically, the IMDs either jointly or
severally can be interrogated to implement or extract clinical
information as required. In other words, all of the IMDs may be
accessed via one IMD or, in the alternate, each one of the IMDs may
be accessed individually. The information collected in this manner
may be transferred to the programmer by up linking the IMDs as
needed.
[0034] Further, the present invention provides significant
advantages over the prior art by enabling remote automated
self-identification information of a programmer. The automated
self-identification scheme is compatible with a global preferably
web-based data center which is configured to interrogate and obtain
the identification of components. Primarily, the
component-identification procedure relates to the programmer-IMD
sessions. Components used in these sessions are identified and
centrally logged for reference and compliance requirements.
Generally, the web-based expert data center will interrogate the
programmer to identify components used in the sessions.
[0035] The invention provides significant compatibility and
scalability to other web-based applications such as telemedicine
and emerging web-based technologies such as tele-immersion. For
example, the system may be adapted to webtop applications in which
a webtop unit may be used to uplink the patient to a remote data
center for non-critical information exchange between the IMDs and
the remote expert data center. In these and other web-based similar
applications the data collected, in the manner and substance of the
present invention, may be used as a preliminary screening to
identify the need for further intervention using the advanced web
technologies.
[0036] In the context of the system and method of the invention,
several advantages are provided including: (a) the ability to
provide a remote connection between a programmer and a centralized
remote expert data center; (b) the ability to transmit
identification information for components of the programmer to the
remote expert data center; (c) the ability to transmit information
relating to a location of an implant procedure to a remote expert
data center; (d) the ability to transmit information relating to a
data and a time of an implant procedure to a remote expert data
center; (e) the ability to remotely and automatically generate an
itemized bill including all implemented medical components during
an implant procedure; (f) the ability to automatically forward an
itemized bill including all implemented medical components from a
remote expert data center to a medical facility where the implant
procedure took place; and (g) the ability to automatically and
remotely generate an inventory including all medical components of
implanted devices in a patient and an ability to automatically
forward the inventory to an inventory management system.
[0037] The system and method of the invention has certain features,
including a data communications link/connection between a
programmer used in conjunction with IMDs and a remote expert data
center. The programmer is located at a location distinct from the
location of the remote expert data center. The invention further
includes a medical instrument capable of identifying each medical
component implanted into a patient. The invention further includes
an information preparation module and data communication with the
remote expert data center which receives information identifying
each implanted medical component and prepares an invoice listing
each of the implanted medical components. The invention further
includes an inventory control module and a data communication
scheme with the information network that receives the information
identifying each implanted medical component and forwards the
identification data to an inventory management system.
[0038] Other advantages, and features of the invention will become
apparent by referring to the appended drawings, detailed
description, and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The present invention will be appreciated as the same
becomes better understood by reference to the following detailed
description of the preferred embodiment of the invention when
considered in connection with the accompanying drawings, in which
like numbered reference numbers designate like parts throughout the
figures thereof, and wherein:
[0040] FIG. 1 is a simplified schematic diagram of major uplink and
downlink telemetry communications between a remote clinical
station, a programmer and a plurality of implantable medical
devices (IMDs);
[0041] FIG. 2 is a block diagram representing the major components
of an IMD;
[0042] FIG. 3A is a block diagram presenting the major components
of a programmer or webtop unit;
[0043] FIG. 3B is a block diagram representing a laser transceiver
for high speed transmission of voice, video and other data;
[0044] FIG. 4 is a block diagram illustrating the organizational
structure of the wireless communication system in accordance with
the present invention;
[0045] FIG. 5 is a block diagram of an implantable medical
component used in conjunction with an implantable medical
device.
[0046] FIG. 6 is a simplified block diagram showing the overall
system of the present invention.
[0047] FIG. 7 is a detailed block diagram showing an overall
programmer invoice and inventory system used in conjunction with
the present invention.
[0048] FIG. 8 is a flow chart illustrating a method of remote
invoicing of a medical component used in conjunction with an
implantable medical device system.
[0049] FIG. 9 is a flow chart illustrating a method of remotely
controlling inventory of a medical component used in conjunction
with an implantable medical device system.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0050] FIG. 1 is a simplified schematic of the major components of
the present invention. Specifically, a bi-directional wireless
communications system between programmer 20, webtop unit 20' and a
number of implantable medical devices (IMDS) represented by IMD 10,
IMD 10' and IMD 10" is shown. The IMDs are implanted in patient 12
beneath the skin or muscle. The IMDs are electrically coupled to
electrodes 18, 3 0, and 3 6 respectively in a manner known in the
art. IMD 10 contains a microprocessor for timing, sensing and
pacing functions consistent with preset programmed functions.
Similarly, IMDs 10' and 10" are microprocessor-based to provide
timing and sensing functions to execute the clinical functions for
which they are employed. For example, IMD 10' could provide neural
stimulation to the brain via electrode 30 and IMD 10" may function
as a drug delivery system that is controlled by electrode 36. The
various functions of the IMDs are coordinated using wireless
telemetry. Wireless links 42, 44 and 46 jointly and severally
couple IMDs 10, 10' and 10" such that programmer 20 may transmit
commands or data to any or all the of IMDs via one of telemetry
antennas 28, 32 and 38. This structure provides a highly flexible
and economical wireless communications system between the IMDS.
Further, the structure provides a redundant communications system,
which enables access to any one of a multiplicity of IMDs in the
event of a malfunction of one or two of antennas 28, 32 and 38.
[0051] Programming commands or data are transmitted from programmer
20 to IMDs 10, 10' and 10" via external RF telemetry antenna 24.
Telemetry antenna 24 may be an RF head or equivalent. Antenna 24
may be located on programmer 20 externally on the case or housing.
Telemetry antenna 24 is generally telescoping and may be adjustable
on the case of programmer 20. Both programmer 20 and webtop unit
20' may be placed a few feet away from patient 12 and would still
be within range to wirelessly communicate with telemetry antennas
28, 32 and 38.
[0052] The uplink to remote web-based expert data center 62,
hereinafter referred to as, interchangeably, "data center 62",
"expert data center 62" or "web-based data center 62" without
limitations, is accomplished through programmer 20 or webtop unit
20'. Accordingly programmer 20 and webtop unit 20' function as an
interface between IMDs 10, 10' and 10" and data center 62. One of
the many distinguishing elements of the present invention includes
the use of various scalable, reliable and high-speed wireless
communication systems to bi-directionally transmit high fidelity
digital/analog data between programmer 20 and data center 62.
[0053] There are a variety of wireless mediums through which data
communications could be established between programmer 20 or webtop
unit 20' and data center 62. The communications link between
Programmer 20 or webtop unit 20' and data center 62 could be modem
60, which is connected to programmer 20 on one side at line 63 and
data center 62 at line 64 on the other side. In this case, data is
transferred from data center 62 to programmer 20 via modem 60.
Alternate data transmission systems include, without limitations,
stationary microwave and/or RF antennas 48 being wirelessly
connected to programmer 20 via tunable frequency wave delineated by
line 50. Antenna 48 is in communications with data center 62 via
wireless link 65. Similarly, webtop unit 20', mobile vehicle 52 and
satellite 56 are in communications with data center 62 via wireless
link 65. Further, mobile system 52 and satellite 56 are in wireless
communications with programmer 20 or webtop unit 20' via tunable
frequency waves 54 and 58, respectively.
[0054] In the preferred embodiment a Telnet system is used to
wirelessly access data center 62. Telnet emulates a client/server
model and requires that the client run a dedicated software to
access data center 62. The Telnet scheme envisioned for use with
the present invention includes various operating systems including
UNIX, Macintosh, and all versions of Windows.
[0055] Functionally, an operator at programmer 20 or an operator at
data center 62 would initiate remote contact. Programmer 20 is down
linkable to IMDs via link antennas 28, 32 and 38 to enable data
reception and transmission. For example, an operator or a clinician
at data center 62 may downlink to programmer 20 to perform a
routine or a scheduled evaluation of programmer 20. In this case
the wireless communication is made via wireless link 65. If a
downlink is required from programmer 20 to IMD 10 for example, the
downlink is effected using telemetry antenna 22. In the alternate,
if an uplink is initiated from patient 12 to programmer 20 the
uplink is executed via wireless link 26. As discussed herein below,
each antenna from the IMDs can be used to uplink all or one of the
IMDs to programmer 20. For example, IMD 10" which relates to neural
implant 30 can be implemented to up-link, via wireless antenna 34
or wireless antenna 34', any one, two or more IMDs to programmer
20. Preferably bluetooth chips, adopted to function within the body
to outside the body and also adopted to provide low current drain,
are embedded in order to provide wireless and seamless connections
42, 44 and 46 between IMDs 10, 10' and 10". The communication
scheme is designed to be broadband compatible and capable of
simultaneously supporting multiple information sets and
architecture, transmitting at relatively high speed, to provide
data, sound and video services on demand.
[0056] FIG. 2 illustrates typical components of an IMD, such as
those contemplated by the present invention. Specifically, major
operative structures common to all IMDs 10, 10' and 10" are
represented in a generic format. In the interest of brevity, IMD 10
relative to FIG. 2 refers to all the other IMDs. Accordingly, IMD
10 is implanted in patient 12 beneath the patient's skin or muscle
and is electrically coupled to heart 16 of patient 12 through
pace/sense electrodes and lead conductor(s) of at least one cardiac
pacing lead 18 in a manner known in the art. IMD 10 contains timing
control 72 including operating system that may employ
microprocessor 74 or a digital state machine for timing, sensing
and pacing functions in accordance with a programmed operating
mode. IMD 10 also contains sense amplifiers for detecting cardiac
signals, patient activity sensors or other physiologic sensors for
sensing the need for cardiac output, and pulse generating output
circuits for delivering pacing pulses to at least one heart chamber
of heart 16 under control of the operating system in a manner well
known in the prior art. The operating system includes memory
registers or RAM/ROM 76 for storing a variety of programmed-in
operating mode and parameter values that are used by the operating
system. The memory registers or RAM/ROM 76 may also be used for
storing data compiled from sensed cardiac activity and/or relating
to device operating history or sensed physiologic parameters for
telemetry out on receipt of a retrieval or interrogation
instruction. All of these functions and operations are well known
in the art, and many are generally employed to store operating
commands and data for controlling device operation and for later
retrieval to diagnose device function or patient condition.
[0057] Programming commands or data are transmitted between IMD 10
RF telemetry antenna 28, for example, and an external RF telemetry
antenna 24 associated with programmer 20. In this case, it is not
necessary that the external RF telemetry antenna 24 be contained in
a programmer RF head so that it can be located close to the
patient's skin overlying IMD10. Instead, the external RF telemetry
antenna 24 can be located on the case of programmer 20. It should
be noted that programmer 20 can be located some distance away from
patient 12 and is locally placed proximate to the IMDs such that
the communication between IMDs 10, 10' and 10" and programmer 20 is
telemetric. For example, programmer 20 and external RF telemetry
antenna 24 may be on a stand a few meters or so away from patient
12. Moreover, patient 12 may be active and could be exercising on a
treadmill or the like during an uplink telemetry interrogation of
real time ECG or other physiologic parameters. Programmer 20 may
also be designed to universally program existing IMDs that employ
RF telemetry antennas of the prior art and therefore also have a
conventional programmer RF head and associated software for
selective use therewith.
[0058] In an uplink communication between IMD 10 and programmer 20,
for example, telemetry transmission 22 is activated to operate as a
transmitter and external RF telemetry antenna 24 operates as a
telemetry receiver. In this manner data and information may be
transmitted from IMD10 to programmer 20. In the alternate, IMD 10
RF telemetry antenna 26 operates as a telemetry receiver antenna to
downlink data and information from programmer 20. Both RF telemetry
antennas 22 and 26 are coupled to a transceiver comprising a
transmitter and a receiver.
[0059] FIG. 3A is a simplified circuit block diagram of major
functional components of programmer 20. The external RF telemetry
antenna 24 on programmer 20 is coupled to a telemetry transceiver
86 and antenna driver circuit board including a telemetry
transmitter and telemetry receiver 34. The telemetry transmitter
and telemetry receiver are coupled to control circuitry and
registers operated under the control of microremote expert data
center 80. Similarly, within IMD 10, for example, the RF telemetry
antenna 26 is coupled to a telemetry transceiver comprising a
telemetry transmitter and telemetry receiver. The telemetry
transmitter and telemetry receiver in IMD 10 are coupled to control
circuitry and registers operated under the control of micro remote
expert data center 74.
[0060] Further referring to FIG. 3A, programmer 20 is a personal
remote expert data center type, microprocessor-based device
incorporating a central processing unit, which may be, for example,
an Intel Pentium microprocessor or the like. A system bus
interconnects CPU 80 with a hard disk drive, storing operational
programs and data, and with a graphics circuit and an interface
controller module. A floppy disk drive or a CD ROM drive is also
coupled to the bus and is accessible via a disk insertion slot
within the housing of programmer 20. Programmer 20 further
comprises an interface module, which includes a digital circuit, a
non-isolated analog circuit, and an isolated analog circuit. The
digital circuit enables the interface module to communicate with
interface controller module. Operation of the programmer in
accordance with the present invention is controlled by
microprocessor 80.
[0061] In order for the physician or other caregiver or operator to
communicate with the programmer 20, a keyboard or input 82 coupled
to CPU 80 is optionally provided. However the primary
communications mode may be through graphics display screen of the
well-known "touch sensitive" type controlled by a graphics circuit.
A user of programmer 20 may interact therewith through the use of a
stylus, also coupled to a graphics circuit, which is used to point
to various locations on screen or display 84 which display menu
choices for selection by the user or an alphanumeric keyboard for
entering text or numbers and other symbols. Various touch-screen
assemblies are known and commercially available. Display 84 and or
the keyboard comprise means for entering command signals from the
operator to initiate transmissions of downlink or uplink telemetry
and to initiate and control telemetry sessions once a telemetry
link with data center 62 or an implanted device has been
established. Display screen 84 is also used to display patient
related data and menu choices and data entry fields used in
entering the data in accordance with the present invention as
described below. Display screen 84 also displays a variety of
screens of telemetered out data or real time data. Display screen
84 may also display plinked event signals as they are received and
thereby serve as a means for enabling the operator to timely review
link-history and status.
[0062] Programmer 20 further comprises an interface module, which
includes digital circuit, non-isolated analog circuit, and isolated
analog circuit. The digital circuit enables the interface module to
communicate with the interface controller module. As indicated
hereinabove, the operation of programmer 20, in accordance with the
present invention, is controlled by microprocessor 80. Programmer
20 is preferably of the type that is disclosed in U.S. Pat. No.
5,345,362 to Winkler, which is incorporated by reference herein in
its entirety.
[0063] Screen 84 may also display up-linked event signals when
received and thereby serve as a means for enabling the operator of
programmer 20 to correlate the receipt of uplink telemetry from an
implanted device with the application of a response-provoking
action to the patient's body as needed. Programmer 20 is also
provided with a strip chart printer or the like coupled to
interface controller module so that a hard copy of a patient's ECG,
EGM, marker channel of graphics displayed on the display screen can
be generated.
[0064] As will be appreciated by those of ordinary skill in the
art, it is often desirable to provide a means for programmer 20 to
adapt its mode of operation depending upon the type or generation
of implanted medical device to be programmed and to be compliant
with the wireless communications system through which data and
information is transmitted between programmer 20 and data center
62.
[0065] FIG. 3B is an illustration of the major components of Wave
unit 90 utilizing laser technologies such as for example the
WaveStar Optic Air Unit, manufactured by Lucent Technologies or
equivalent. This embodiment may be implemented for large data
transfer at high speed in applications involving several
programmers. The unit includes laser 92, transceiver 94 and
amplifier 96. A first wave unit 90 is installed at data center 62
and a second unit 90' is located proximate to programmer 20 or
webtop unit 20'. Data transmission between remote data center 62
and programmer unit 20 is executed via wave units 90. Typically,
the first wave unit 90 accepts data and splits it into unique
wavelength for transmission. The second wave unit 90' recomposes
the data back to its original form.
[0066] FIG. 4 is a simplified block diagram illustrating the
principal systems of the invention. The Remote expert system or
data center 62 includes data resource 100. As discussed
hereinabove, data center 62 is preferably in wireless
communications with programmer 20. The medium of communications
between programmer 20 and data center 62 may be selected from one
or a combination of several cable and wireless systems discussed
hereinabove. Further, programmer 20 is in wireless communications
with a number of IMDs, such as shown in FIG. 1. Although three IMDs
are shown for illustrative purposes, it should be noted that
several IMDs may be implemented and the practice of the present
invention does not limit the number of implants per se.
[0067] FIG. 5 is a block diagram illustrating an implantable
medical component which is implanted in a patient under medically
accepted standard implantation procedures. For example, implantable
medical component 230 represents IMD 10, pacing and sensing leads
16 and 18, or any other implantable medical component which is
implanted in a patient. Implantable medical component 230 includes
memory component 232 which can be a microprocessor, a memory
component of a read-only memory (ROM) device, or any other
component capable of storing information. Memory component 232
stores identification information which specifically identifies
implantable medical component 230. Memory component 232 stores
various information which identifies implantable medical component
230. For example, memory component 232 stores bar code information
234, serial number 236, and model number 238; each of which
provides specific identifying information about implantable medical
component 230. Therefore, by retrieving information from memory
component 232, implantable medical component 230 can be
specifically identified.
[0068] FIG. 6 is a simplified block diagram illustrating the
principle system used in conjunction with the invention. System 250
includes programmer 252 and remote expert data center 254
interconnected via data communications link/connection 256.
Programmer 252 is located within medical facility 260 (shown in
FIG. 6, such as a clinic, hospital, or physician's office.
[0069] Programming system 25 includes various instruments including
programmer 200 and analyzer 210. The system is used to program one
or more IMDs as shown in FIG. 4. IMD 10 is one of various devices
such as a pacemaker, defibrillator or combinations thereof. IMDs
may also represent a drug-delivery system, an electrical stimulator
including a nerve or muscle stimulator, a neuro-stimulator, or a
heart-assist device or pump. IMD 10, programmer 200, and analyzer
210 are microprocessor-based components capable of exchanging data
and information between each other via a standard data
communications link.
[0070] Remote expert data center 254 is a remote expert data
centerized network system located at a distal location relative to
programmer 252. For example, remote expert data center 254 can be
located at a central location, such as at a corporate headquarters
or manufacturing facility of the company which manufactures and
owns programmer 252. As shown in FIG. 6, programmer 252 is
connected to remote expert data center 254 via data communications
link/connection 256. Data communications link/connection 256 can be
one of a variety of links or interfaces, such as a local area
network (LAN) connection, an internet connection, a telephone line
connection, a satellite connection, a global positioning system
(GPS) connection, a cellular connection, any combination thereof,
or an equivalent communications link.
[0071] Data communications link/connection 256 permits the exchange
of information between programmer 252 and remote expert data center
254. As discussed below, this novel feature of the invention
provides one of the many distinguishing advances over the prior
art.
[0072] FIG. 7 is a detailed block diagram illustrating the overall
system used in conjunction with the invention. System 250 includes
remote expert data center 254 and medical facility 260. Remote
expert data center 254 is located at a distal location relative to
medical facility 260. Remote expert data center 254 includes
invoice preparation module 262 and inventory control module
264.
[0073] Medical facility 260, which is a hospital, a clinic, or a
medical facility, can be located throughout the world and includes
programmer 252 and accounting system 266. Patient 268 is also
located at medical facility 260. Programmer 252 further includes
programmer 200, analyzer 210, and RF head 258. Patient 268 further
includes heart 8, IMD 10, and pacing and/or sensing leads 16 and
18.
[0074] Programmer 252 is connected to remote expert data center 254
via data communication links/connection 256. Similarly, remote
expert data center 254 is connected to medical facility 260 via
data communications link/connection 270. Data communication
links/connections 256 and 270 can be one of a variety of links or
interfaces, such as a LAN connection, an internet connection, a
telephone connection, a satellite connection, a GPS connection, any
combination thereof, or an equivalent communication link.
Similarly, programmer 252 is in data communication with IMD 10 via
RF head 258.
[0075] Once an implant procedure has been completed and medical
components such as IMD 10 and pacing and/or sensing leads 16 and
18, are implanted into patient 268, it is critical that information
identifying each medical component implanted into patient 268 is
identified. Further, it is important that this identifying
information is forwarded to the owner or manufacturer of the
individual medical components so that the owner or manufacturer of
the medical components can generate a bill for the implanted
medical components and forward the bill to medical facility 260 for
payment. Also, the owner or manufacturer of the medical components
can control inventory of the implanted medical component at medical
facility 260.
[0076] Prior art systems require a medical personnel, such as a
physician, to prepare paperwork identifying the implanted medical
components or physically enter the identifying information into a
data entry system. The identifying information is then routed
through medical facility 260, and eventually a report itemizing all
implanted components is generated and transmitted to the owner or
manufacture of the implantable medical devices. The owner or
manufacturer of the implantable medical components must then
generate an invoice and forward the invoice to medical facility 260
requesting payment. Additionally, the owner or manufacturer of the
implanted medical components must track the inventory of various
medical components at numerous medical facilities located
throughout the world, including medical facility 260. This prior
art process is manual labor intensive in that each step in the
process requires a person to physically write down identifying
information regarding each implanted medical component or enter
identifying information for each implanted medical component into a
data entry system. This entire process often takes weeks or even
months to be completed. Therefore, at any given time, millions of
dollars of medical components have been implanted into patients
throughout the world; however, no billing or inventory information
has been generated regarding these components.
[0077] With system 250 shown in FIG. 7, the above-discussed
limitations in preparing an invoice and controlling inventory in a
time-sensitive manner are alleviated. Specifically, with system
250, the inventory and invoicing processes are automated such that
manual entries are no longer required.
[0078] As previously discussed, during the manufacture process of
implantable medical components, such as IMD 10 and pacing and/or
sensing leads 16 and 18, identifying information is programmed into
a memory device of each component. For example, bar code
information 234, serial number 236, and model number 238, shown in
FIG. 7, are programmed into a microprocessor or ROM device during a
manufacture process. During an implant procedure, programmer 252 is
connected to patient 268 via RF head 258. Programmer 252, through
specific use of programmer 200 and analyzer 210, both assesses the
performance of pacing and/or sensing leads 16 and 18 during the
implantation procedure and programs IMD 10. Therefore, programmer
252 is in data communication with IMD 10 and pacing and/or sensing
leads 16 and 18 during an implant procedure. Programmer 252 is also
in data communication with remote expert data center 254. Remote
expert data center 254 is located at a distal location relative to
programmer 252.
[0079] The identifying information of each implanted medical
component is transmitted from programmer 252 to remote expert data
center 254 via data communications link/connection 256. The
identifying information for each implanted medical component is
automatically forwarded to invoice preparation module 262 within
remote expert data center 254. Invoice preparation module 262
automatically prepares an invoice or bill itemizing each implanted
medical component. In one embodiment, each implanted medical
component is identified by its identifying information, such as bar
code information, serial number, and/or model number. The itemized
invoice is then automatically forwarded to medical facility 260 via
data communications link/connection 270. Similar to data
communications link/connection 256, data communications
link/connection 270 can be one of a variety of links or interfaces,
such as a LAN connection, an internet connection, a telephone line
connection, a satellite connection, a GPS connection, any
combination thereof, or an equivalent thereof. In one embodiment of
the present invention, the itemized bill or invoice is transmitted
directly to accounting system 266 of medical facility 260 from
remote expert data center 254 requesting payment.
[0080] The above-process is an entirely automated process which
alleviates both operator error and time delays throughout the
process due to operator inefficiency. With system 250, an invoice
itemizing each remote medical component implanted into patient 268
can be automatically and instantaneously generated and transmitted
to medical facility 260. The entire process takes seconds, rather
than the weeks or months previously needed for this process.
[0081] Consistent with the above-discussed process, once the
identifying information regarding each implanted medical component
has been transmitted to remote expert data center 254, it is also
instantaneously transmitted to inventory control module 264.
Inventory control module 264 contains remote expert data center
generated data regarding the quantity of specific medical
components at various medical facilities throughout the world,
including medical facility 260. It is important that medical
facility 260 have the proper amount of each implantable medical
component. The specific number of implantable medical components at
medical facility 260 can vary depending upon the frequency of
implantation of the specific medical component. However, it is
critical that enough medical components are inventoried at medical
facility 260 so that a specific medical component is available for
an implant procedure. It is also important that medical facility
260 does not have an over abundant amount of specific medical
components such that the medical component can no longer be
implanted into a patient due to expiration of the component. For
example, the Food and Drug Administration (FDA) has specific
requirements regarding the age of a component before it can no
longer be implanted into a patient. If the component has been
manufactured prior to a specific date, the FDA may prevent
implantation of the device.
[0082] Once the identifying information of each remote medical
component has been transmitted to inventory control module 264,
inventory control module 264 can automatically generate an
inventory request to forward medical components to medical facility
260 to replace the implanted components.
[0083] FIG. 8 is a flow chart illustrating a method of
automatically generating an invoice and forwarding the invoice to
medical facility 260. Method 300 begins with step 302, wherein a
memory portion 232 of implantable medical component 230 is
programmed with identifying information providing identification of
the implantable medical component. As previously discussed, a
microprocessor or ROM device can be programmed with identifying
information such as bar code information 234, serial number 236,
and model number 238. At step 304, implantable medical component
230 is implanted into patient 268 as part of an implantable medical
device system. In one embodiment of the present invention,
implantable medical component 230 is either IMD 10 or pacing and/or
sensing leads 16 and 18.
[0084] At step 306, an interface between the implantable medical
device system and remote expert data center 254 located at a distal
location relative to the implantable medical device system is
initiated. As previously discussed, the interface, such as data
communications link/connection 256 can be one of a variety of links
or interfaces, such as a LAN connection, an internet connection, a
telephone line connection, a satellite connection, a GPS
connection, any combination thereof, or an equivalent
communications link. At step 308, the identifying information of
implantable medical component 230 implanted into patient 268 is
transmitted to remote expert data center 254. In addition to
transferring the identifying information, operator information
regarding an implanting physician, timing information regarding a
date and time of the implant procedure, and medical facility
information regarding the location of the implant procedure is
transmitted to remote expert data center 254, as shown at step
310.
[0085] At step 312, an automated invoice is prepared on remote
expert data center 254 for implantable medical component 230 based
upon the identifying information. The preparation of the invoice
occurs within invoice preparation module 262. The invoice may also
include information regarding the implanting physician, the date
and time of the implant procedure, and the location of the implant
procedure. The invoice is transmitted to medical facility 260 where
the implant procedure occurred, as shown at step 314. In one
embodiment of the present invention, the invoice is transmitted
directly to accounting system 266 of medical facility 260 via data
communications link/connection 270.
[0086] FIG. 9 is another flow chart illustrating a method of
controlling inventory of medical components within medical facility
260. Method 320 includes steps 302-310 which are identical to steps
302-310 of FIG. 10, and have been labeled as such. Method 320
deviates from method 300 shown in FIG. 10 at step 322 where the
identifying information of implantable medical component 230 is
transmitted to inventory control system 264. At step 324, the
inventory of medical component 230 at medical facility 260 is
controlled. In one preferred embodiment, inventory control module
264 automatically generates a transmittal order requiring the owner
or manufacturer of remote medical component to transmit a
replacement of implantable medical component 230 to medical
facility 260 to replace the implanted component. Therefore, the
inventory of a specific medical component at medical facility 260
is precisely controlled such that a proper number of medical
components are within the inventory of medical facility 260.
[0087] Although specific embodiments of the invention have been set
forth herein in some detail, it is understood that this has been
done for the purposes of illustration only and is not to be taken
as a limitation on the scope of the invention as defined in the
appended claims. It is to be understood that various alterations,
substitutions, and modifications may be made to the embodiment
described herein without departing from the spirit and scope of the
appended claims.
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