U.S. patent application number 12/476906 was filed with the patent office on 2009-10-01 for method of selling procedure specific allografts and associated instrumentation.
Invention is credited to Reinhold Schmieding.
Application Number | 20090248592 12/476906 |
Document ID | / |
Family ID | 26934557 |
Filed Date | 2009-10-01 |
United States Patent
Application |
20090248592 |
Kind Code |
A1 |
Schmieding; Reinhold |
October 1, 2009 |
METHOD OF SELLING PROCEDURE SPECIFIC ALLOGRAFTS AND ASSOCIATED
INSTRUMENTATION
Abstract
A method for selling a product and all phases of service and
support to a customer for optimal use of the product includes
customizing a product for a surgical allograft procedure to be
performed and providing the customized product and services as an
integrated turnkey package to a medical provider. The products
include bone and soft tissue allografts for all types of orthopedic
reconstructive procedures and a loan of the associated
instrumentation. The service portion of the package includes
training support on use of the instruments, training of operating
room personnel, technical and customer support both before the
performance of the procedure and on-site support. After completion
of the surgical procedure, the service provider arranges for the
return of the loaned instrumentation.
Inventors: |
Schmieding; Reinhold;
(Naples, FL) |
Correspondence
Address: |
DICKSTEIN SHAPIRO LLP
1825 EYE STREET NW
Washington
DC
20006-5403
US
|
Family ID: |
26934557 |
Appl. No.: |
12/476906 |
Filed: |
June 2, 2009 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
09981752 |
Oct 19, 2001 |
7548865 |
|
|
12476906 |
|
|
|
|
60241764 |
Oct 20, 2000 |
|
|
|
Current U.S.
Class: |
705/500 ;
128/898 |
Current CPC
Class: |
G16H 20/40 20180101;
G06Q 99/00 20130101; A61F 2002/2835 20130101; G06Q 30/02 20130101;
A61F 2002/2839 20130101; G06Q 10/10 20130101 |
Class at
Publication: |
705/500 ;
128/898 |
International
Class: |
G06Q 90/00 20060101
G06Q090/00; A61B 17/00 20060101 A61B017/00 |
Claims
1-17. (canceled)
18. A method of preparing a customized donor allograft for a
predetermined surgical procedure, the method comprising: receiving
predetermined specifications and conditions of a patient to undergo
the predetermined surgical procedure, said predetermined
specifications and conditions being received from a medical
provider; harvesting and sizing to a specific diameter, length,
width and/or thickness, at least one of a meniscal and an
osteochondral donor allograft according to the predetermined
specifications and conditions of the patient, and also according to
the predetermined surgical procedure to be performed on the
patient, thereby creating said customized donor allograft;
effecting delivery of the customized donor allograft to the medical
provider, and delivering surgical instrumentation to the medical
provider, said surgical instrumentation being selected based on the
customized donor allograft and on the predetermined surgical
procedure.
19. The method of claim 18, wherein a tissue bank delivers the
customized donor allograft directly to the medical provider.
20. The method of claim 18, wherein the surgical instrumentation
includes at least one of a fixation plate and an interference
screw.
21. The method of claim 18, wherein the customized donor allograft
is prepared without the use of antibiotics.
22. The method of claim 18, wherein the customized donor allograft
is delivered to a medical facility at which the predetermined
surgical procedure is to be performed.
23. The method of claim 18, further comprising training operating
personnel in the use of the surgical instrumentation to perform the
predetermined surgical procedure.
24. The method of claim 18, wherein the surgical instrumentation is
loaned to the medical provider, and wherein the medical provider
returns the surgical instrumentation to the first business entity
after the predetermined surgical procedure is completed.
25. The method according to claim 18, further comprising providing
technical support during the procedure.
26. The method according to claim 25, wherein the step of providing
technical support includes providing for the presence of trained
representative knowledgeable in the use of the instruments and the
performance of the surgical procedure at an operation location
during the procedure.
Description
[0001] This application claims the benefit of U.S. Provisional
Application Ser. No. 60/241,764, filed Oct. 20, 2000.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a business method of
selling a surgical product and necessary instrumentation for using
the product together with a service package including training for
using the product and associated instruments, customer service and
technical support.
[0004] 2. Brief Description of the Related Art
[0005] In preparing to perform a surgical procedure requiring a
bone or soft tissue allograft, it was heretofore necessary for the
surgeon, hospital, or medical center performing the procedure to
make arrangements with a tissue bank for the delivery of the
allograft within the appropriate time window prior to the surgery.
If the surgeon or medical facility does not already own the
necessary instrumentation to be used to perform the procedure, then
separate arrangements must also be made to purchase, lease or
borrow the appropriate instruments through a provider or another
medical facility. Additionally, the surgeon performing the
procedure may need training if he or she is unfamiliar with the
procedure or needs a "refresher" course, thus requiring additional
arrangements to be made with yet another entity who can provide the
training. Thus, the administrative preparation for the surgical
procedure can become quite complex and time consuming for the
medical provider.
SUMMARY OF THE INVENTION
[0006] To address the disadvantages encountered in the prior art,
it is an object of the present invention to streamline the
pre-operative process for the medical provider to thereby enable
the medical provider to focus on providing medical care to its
patients.
[0007] It is also an object of the present invention to provide a
comprehensive turnkey service to a medical provider as support for
the performing of a surgical allograft procedure.
[0008] It is a further object of the present invention to provide a
business method of selling a surgical product along with a loan of
the necessary instrumentation for using the product, together with
a service package including training on using the product and
associated instruments, customer service and technical support.
[0009] It is a still further object of the present invention to
maintain an ongoing business relationship with a source provider of
the surgical product as part of the business method to facilitate
providing the turnkey service to the medical provider.
[0010] The present invention is a method for selling a product and
all phases of service and support to a customer for optimal use of
the product. Moreover, the product itself is specially designed
according to the conditions and needs of the procedure to be
performed.
[0011] In particular, the products include bone and soft tissue
allografts for all types of orthopedic reconstructive procedures
and a loan of the associated instrumentation. The service portion
of the package includes training support on use of the instruments,
training of operating room personnel, technical in-service and
customer support.
[0012] When the surgeon determines that allograft surgery is
necessary, upon compiling the necessary medical data, the surgeon
or hospital places the order for the allograft through the service
provider, who then makes the appropriate arrangements to coordinate
the delivery of the allograft from a tissue bank with the assembly
and delivery of a customized set of instrumentation for the
specific procedure. The service provider also arranges for any
training which may be necessary for the surgeon, provides for the
presence of a service representative in the operating room to
assist the surgeon during the procedure, and arranges for the
return of the loaned instrumentation after the procedure.
[0013] Other features and advantages of the present invention will
become apparent from the following description of the invention
which refers to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWING
[0014] FIG. 1 is a flowchart illustrating the method in accordance
with the present invention.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0015] The present invention is a business method of providing an
integrated product and service package for orthopedic surgery
practitioners, and is illustrated in the flow chart shown in FIG.
1. Specifically, the inventive method serves as a single source
provider of bone and soft tissue allografts for reconstructive
surgical procedures, associated instrumentation and peripheral
materials to perform the specified surgical procedure, and all
levels of training, service and support in the use of the
products.
[0016] Upon determination between an orthopedic surgeon and a
patient that a reconstructive procedure is to be performed (step
S1), the practitioner determines the specifications for the grafts
needed for the procedure, and then collects relevant records and
information useful for obtaining a customized allograft for the
procedure (step S2). Such data to be collected may include the
patient's blood type, the identification of any antibiotic or other
allergies suffered by the patient, the dimensions of the grafts
needed, X-rays and/or other pre-operative documentation.
[0017] The surgeon or the medical facility then places an order
with the service provider which practices the business method of
the present invention, and provides the obtained medical data to
the service provider (step S3). The medical provider can order the
allograft together with a loan of the associated instrumentation
for performing the allograft procedure, or, if the medical provider
already owns the appropriate instrumentation, the allograft
only.
[0018] As part of the overhead structure of the business method
arrangement, the service provider maintains an ongoing relationship
with one or more tissue banks, in which the service provider
provides instrumentation and training to the tissue bank personnel
as needed for harvesting the allografts in accordance with the
processing techniques and specifications for the procedures
indicated by the customer. Such relationship is mutually beneficial
to both the service provider and the tissue bank since the tissue
bank personnel receives updated equipment and ongoing opportunities
for training in the use of the instrumentation and harvesting
techniques, while the service provider is assured of a reliable
source of size specific allografts prepared specifically for the
surgical procedures to be performed and the instrumentation to be
used by the customers.
[0019] In accordance with the business arrangement between the
tissue bank(s) and the service provider, when an order is received
from a medical provider customer, the service provider contacts the
tissue bank to arrange for a graft to be harvested in accordance
with the specifications and indications provided by the medical
provider, and to schedule the delivery of the allograft within a
designated time frame prior to the scheduled surgery (step S4).
[0020] The allografts are harvested at the tissue bank from donors
under standard operating room sterile techniques and are subjected
to extensive tests and studies to guard against the possibility of
transmission of HIV, hepatitis, and other infections and to avoid
problems with recipient immune sensitization and antibiotic
sensitivities.
[0021] The allografts are preferably non-irradiated and can be
preserved by any method, including fresh preserved, fresh freezing,
cryopreservation, freeze-drying, and decellurization. Furthermore,
the allografts are customized to the specifications and conditions
of the patient and the procedure. For example, the dimensions of
the graft can be specifically obtained to accommodate requested
dimensions (diameter, length, width and/or thickness of the
grafts), or if a patient is known to be sensitive to certain
antibiotics normally used in the processing of the allografts, the
allografts can be prepared without the use of antibiotics.
[0022] Examples of the types of grafts which may be supplied in
accordance with the present method include size specific
osteochondral cores; cancellous tunnel plugs; femoral and tibial
meniscus allografts (frozen and cryopreserverd) including femoral
menisci with bone blocks and tibial plateau with meniscus; proximal
tibial and distal femoral bone wedges; cortical cervical rings;
fresh osteochondral allografts such as femoral hemi-condyles, whole
distal femurs, trochleas, talus, and patellas; and anterior
cruciate and posterior cruciate ligament reconstruction allografts
(frozen and cryopreserved) including Achilles tendons with bone
blocks, quadriceps tendons with bone blocks, hamstrings
(semi-tendinosus, gracilis), anterior and posterior tibialis
tendons, bone-tendon-bone tendons, and hand and foot flexor and
extensor tendons.
[0023] For each order in which a loan of the corresponding
instrumentation for the selected allograft has been requested, a
customized instrumentation kit is assembled to include the
appropriate precision instruments and fixation elements, such as
fixation plates, interference screws, etc., taking into account the
type and size of the requested allograft, for optimally implanting
the graft (step S5). Preferably, the instruments loaned to the
surgeon or medical facility for the operation are owned by the
service provider. Alternatively, the service provider may arrange
for the instruments to be sent to the surgeon or medical facility
from another provider.
[0024] The service provider confirms the delivery date of the
grafts and works with the patient's medical team to establish a
system of training, if necessary, to take place either at the
surgeon's facilities and/or an outside training facility, which may
be operated by the service provider or a third party (step S6).
[0025] In accordance with the schedule determined between the
service provider and the surgeon, the graft specific
instrumentation, fixation aids, and associated materials are
delivered to the operating location for in-service with the
operating room staff and for sterilization (if not already provided
in a sterilized state) (step S8). Meanwhile, at the tissue bank,
the allograft is harvested according to the specifications
indicated by the medical provider (step S7), and then packaged and
shipped to the surgeon or hospital in a cooled packaging, if
necessary (step S9). The delivery of the graft is coordinated to be
delivered to the designated medical facility with a simultaneous or
temporally proximal delivery of the graft specific instrumentation
and related materials needed to perform the implantation.
Preferably, the procedure specific allograft is shipped from the
tissue bank by overnight delivery to the operating location 1-2
days in advance of the surgery, to arrive no later than the day of
the operation.
[0026] If the operation is unforeseeably postponed or otherwise
does not take place withing a day or two of the date the allograft
is received from the tissue bank, the surgeon should at least keep
in mind that fresh grafts such as precut osteochondral cores must
be used within 14 days to maintain live cells in the allograft.
With frozen or cryopreserved allografts, however, more flexibility
may be afforded for the usable time frame of the graft, provided
the receiving medical provider has adequate storage facilities to
appropriately maintain the viability of the graft.
[0027] Prior to and during the surgical procedure, the service
provider provides technical and customer support to ensure smooth
operation of the procedure and to maximize the degree of success
achieved by the procedure (S6, S10). In particular, if desired by
the surgeon, the service provider sends a technical service
representative who is knowledgeable about the surgical procedure
and the use of the instrumentation and associated materials to be
present with the surgeon at the time of surgery (step S10) to
provide technical support and guidance for the surgeon and the
operation staff during the operation (step S11).
[0028] After the operation is completed, a representative of the
provider facilitates return of the loaned instrumentation and any
other non-disposable materials to the provider (step S12).
[0029] As described above, the present invention provides a turnkey
system in which a service provider loans a medical provider a
customized instrumentation kit as an integrated package with the
allograft for a specified surgical procedure, along with training
and technical support services. Since tissue banks generally do not
provide the instrumentation or training needed to implant a graft
harvested from their facilities and instrument companies generally
do not sell allografts, the system of the present invention
streamlines the pre-operative administrative preparation process
for the medical provider so that the medical provider need only
place an order with the service provider for all the necessary
arrangements to prepare for the surgical procedure.
[0030] As a business venture, the turnkey system and method of
providing the integrated product and service package described
herein is profitable for the service provider by charging the
medical provider a fee between about 50% to 100% above the cost of
obtaining the allograft from the tissue bank. The profit collected
by the service provider is based upon the rental of the
instrumentation, the intra-operative support, educational training,
and service coordination efforts, and not on the sale of the
allograft, as such sale would likely pose ethical concerns.
[0031] However, medical facilities often cannot or will not bill
for loaner fees for the instrumentation, because most insurance
carriers only provide coverage for products and services received
for medical care. More specifically, most insurance carriers will
not reimburse a medical provider or a patient for the rental costs
of instrumentation, because they are ultimately returned to the
instrument provider where neither the patient nor the medical
provider will derive further future benefit or use from the loaned
instrumentation (unless another loaner fee is paid to the
instrument provider). Thus, the fee charged for the integrated
product and service package is billed to the customer as the price
of the graft, while the rental of the instrumentation and
associated materials are included for free as part of the package.
In this manner, the entire cost of the package (obtaining the
allograft at cost through the tissue bank plus the rental fee for
the instrumentation) is built into the cost of the allograft. The
tissue bank recovers the cost of providing the allograft from the
service provider. Such cost thus represents a portion of the cost
of the integrated package paid by the medical provider (or the
insurance carrier) to the service provider.
[0032] Although the present invention has been described in
relation to particular embodiments thereof, many other variations
and modifications and other uses will become apparent to those
skilled in the art. It is preferred, therefore, that the present
invention be limited not by the specific disclosure herein, but
only by the appended claims.
* * * * *