CA2871997A1 - Handheld tracking systems and devices for aligning implant systems during surgery - Google Patents
Handheld tracking systems and devices for aligning implant systems during surgery Download PDFInfo
- Publication number
- CA2871997A1 CA2871997A1 CA2871997A CA2871997A CA2871997A1 CA 2871997 A1 CA2871997 A1 CA 2871997A1 CA 2871997 A CA2871997 A CA 2871997A CA 2871997 A CA2871997 A CA 2871997A CA 2871997 A1 CA2871997 A1 CA 2871997A1
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- Canada
- Prior art keywords
- handheld
- patient
- handheld device
- tracking system
- data
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1664—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the hip
- A61B17/1666—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the hip for the acetabulum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00221—Electrical control of surgical instruments with wireless transmission of data, e.g. by infrared radiation or radiowaves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2055—Optical tracking systems
- A61B2034/2057—Details of tracking cameras
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2065—Tracking using image or pattern recognition
Abstract
The present invention discloses handheld tracking systems and devices comprising of at least one handheld tracking device for intra-operative aligning or positioning of surgical implant systems and instruments with reference to the anatomy of a patient. The handheld tracking system further comprises of at least one trackable element. The handheld device is mounted at the proposed implantation site using the holding means while trackable element(s) is/are mounted at predetermined location(s) such that data from said deployed trackable element(s) relating to the position of the patient and the surgical instruments are input continuously into the handheld devices. The handheld device then processes the data on the basis of pre-loaded preoperative scanned images in the processing means to monitor the accurate placement of said implant system onsite in sterile environment.
Description
Title Handheld tracking systems and devices for aligning implant systems during surgery.
Field of Invention The present invention relates to handheld tracking system and devices for aligning implant systems during surgery and the process of performing minimally invasive surgical tracking with the said handheld tracking devices.
This complete specification is cognate of provisional application numbers 1345/DEL/2012 dated 2nd May 2012 and 3283/DEL/2012 dated 25th October 2012 under Section 9(2) of The Patents Act 1970.
Background Over time and through repeated use, bones and joints can become damaged or worn.
The cartilage in the joint areas which provides a cushioning effect on the joints during physical activity can become worn out or damaged due to repetitive strain on bones and joints as in case of athletic activity or when subjected to traumatic events, or due to certain diseases such as osteoarthritis. This condition results in pain, stiffness, and decreased mobility for the patient.
Arthroplasty procedure is commonly used to replace a diseased joint with an artificial joint. During a typical arthroplasty procedure, an arthritic or otherwise dysfunctional joint is reshaped and / or realigned, and an implant system is accurately positioned into the damaged region. Arthroplasty procedures may take place on any of the joints in different regions of the body including but not limited to knee, hip, shoulder and elbow.
One of the key goals of arthroplasty is restoration of the patient anatomy, specifically aligning or the positioning of implant components with reference to the anatomy. This alignment of the implant with the anatomy is usually performed by using mechanical instruments and/ or navigation systems. The disadvantages of using mechanical instruments lie in probability of the inaccurate alignment since these are based on average anatomical relationships and do not take into account any parameter of that particular patient or surgical setup. Also, these mechanical instruments may not be very intuitive and easy to use, requiring large surgical incision as well as continuous monitoring of instruments, while manually aligning the instruments with the key anatomical landmarks on the body. These anatomical landmarks could be unstable resulting in in-accurate judgment.
Further the existing navigation systems in the arthroplasty procedure are very complex and expensive. Using such systems typically requires an additional person to handle the navigation computer outside the sterile area in the operation theater.
Besides, the existing navigation systems depend on direct line-of-sight between external cameras or infra-red sensors placed outside the sterile environment, and navigation instruments used inside the sterile zone in the surgery. This makes the surgical procedure very cumbersome and requires the surgeon to frequently move out of the surgery site so that the camera system present outside the sterile area can see the tracker system present inside the sterile area Therefore, there is a need of handheld tracking system and devices for intra-operatively aligning implant systems on a patient which are simpler to use during surgical procedures yet highly accurate, and which provide greater intra operative flexibility to the surgeon such that it is completely controlled and used inside the sterile field.
Above disadvantages have been addressed in one such article titled "Improving acetabular cup orientation in the total hip arthroplasty by using smartphone technology"
published in the journal of the arthroplasty discloses the use of smartphone for the acetabular placement. The advantages of the use of smartphone assisted surgery are many; for instance accurate digital inclination, less time consumption, no need of external references incisions, and minimum set up requirements. However this article does not discloses information related to accurate detection of anteversion orientation, which is the critical angle. Any inaccuracy in anteversion orientation significantly increases the chances of post-surgery complications such as repeated dislocation.
OBJECTOF THE INVENTION:
Field of Invention The present invention relates to handheld tracking system and devices for aligning implant systems during surgery and the process of performing minimally invasive surgical tracking with the said handheld tracking devices.
This complete specification is cognate of provisional application numbers 1345/DEL/2012 dated 2nd May 2012 and 3283/DEL/2012 dated 25th October 2012 under Section 9(2) of The Patents Act 1970.
Background Over time and through repeated use, bones and joints can become damaged or worn.
The cartilage in the joint areas which provides a cushioning effect on the joints during physical activity can become worn out or damaged due to repetitive strain on bones and joints as in case of athletic activity or when subjected to traumatic events, or due to certain diseases such as osteoarthritis. This condition results in pain, stiffness, and decreased mobility for the patient.
Arthroplasty procedure is commonly used to replace a diseased joint with an artificial joint. During a typical arthroplasty procedure, an arthritic or otherwise dysfunctional joint is reshaped and / or realigned, and an implant system is accurately positioned into the damaged region. Arthroplasty procedures may take place on any of the joints in different regions of the body including but not limited to knee, hip, shoulder and elbow.
One of the key goals of arthroplasty is restoration of the patient anatomy, specifically aligning or the positioning of implant components with reference to the anatomy. This alignment of the implant with the anatomy is usually performed by using mechanical instruments and/ or navigation systems. The disadvantages of using mechanical instruments lie in probability of the inaccurate alignment since these are based on average anatomical relationships and do not take into account any parameter of that particular patient or surgical setup. Also, these mechanical instruments may not be very intuitive and easy to use, requiring large surgical incision as well as continuous monitoring of instruments, while manually aligning the instruments with the key anatomical landmarks on the body. These anatomical landmarks could be unstable resulting in in-accurate judgment.
Further the existing navigation systems in the arthroplasty procedure are very complex and expensive. Using such systems typically requires an additional person to handle the navigation computer outside the sterile area in the operation theater.
Besides, the existing navigation systems depend on direct line-of-sight between external cameras or infra-red sensors placed outside the sterile environment, and navigation instruments used inside the sterile zone in the surgery. This makes the surgical procedure very cumbersome and requires the surgeon to frequently move out of the surgery site so that the camera system present outside the sterile area can see the tracker system present inside the sterile area Therefore, there is a need of handheld tracking system and devices for intra-operatively aligning implant systems on a patient which are simpler to use during surgical procedures yet highly accurate, and which provide greater intra operative flexibility to the surgeon such that it is completely controlled and used inside the sterile field.
Above disadvantages have been addressed in one such article titled "Improving acetabular cup orientation in the total hip arthroplasty by using smartphone technology"
published in the journal of the arthroplasty discloses the use of smartphone for the acetabular placement. The advantages of the use of smartphone assisted surgery are many; for instance accurate digital inclination, less time consumption, no need of external references incisions, and minimum set up requirements. However this article does not discloses information related to accurate detection of anteversion orientation, which is the critical angle. Any inaccuracy in anteversion orientation significantly increases the chances of post-surgery complications such as repeated dislocation.
OBJECTOF THE INVENTION:
2 It is an object of the present invention to provide handheld tracking systems and devices for intra-operatively aligning implant systems and/or surgical instrument with reference to the anatomy of the patient during surgery.
It is another object of the present invention to provide simple, easy to set up handheld tracking systems and devices for accurate positioning and/or sizing of implant system with reference to the anatomy of the patient during surgery and without being dependent on the line-of-sight connectivity outside the sterile area.
It is yet another object of the invention to provide active handheld device capable of indicating the position and/or size information through audio and/ or visual means during surgical procedures.
It is yet another object of the invention to provide handheld tracking system comprising of at least one handheld device having sensors capable of detecting and displaying runtime implant system information within sterile environment.
It is yet another object of the invention to provide handheld device which can be mounted on multiple types of instruments during surgery as well as anchored on to the patient.
It is yet another object of the invention to provide handheld device with the capability of reading and processing pre-operative image based patient data as well as intra-operative images from implant systems, instruments and / or patient position.
It is yet another object of the invention to provide handheld device capable of communicating wirelessly using data communication link or protocol without any external device or reference.
It is yet another object of the invention to provide a method of handheld surgical tracking using the systems and devices of the present invention.
It is another object of the present invention to provide simple, easy to set up handheld tracking systems and devices for accurate positioning and/or sizing of implant system with reference to the anatomy of the patient during surgery and without being dependent on the line-of-sight connectivity outside the sterile area.
It is yet another object of the invention to provide active handheld device capable of indicating the position and/or size information through audio and/ or visual means during surgical procedures.
It is yet another object of the invention to provide handheld tracking system comprising of at least one handheld device having sensors capable of detecting and displaying runtime implant system information within sterile environment.
It is yet another object of the invention to provide handheld device which can be mounted on multiple types of instruments during surgery as well as anchored on to the patient.
It is yet another object of the invention to provide handheld device with the capability of reading and processing pre-operative image based patient data as well as intra-operative images from implant systems, instruments and / or patient position.
It is yet another object of the invention to provide handheld device capable of communicating wirelessly using data communication link or protocol without any external device or reference.
It is yet another object of the invention to provide a method of handheld surgical tracking using the systems and devices of the present invention.
3 PCT/IBL3/53441 03-03-2014 pcTIEF1190.5031411pRif 30111.08.201 4 I
= CA 02871997 2014-10-29 P-504'CT-2 REPLACEMENT SHEET
I
. .
Al It is yet another object of the invention to provide cost effective and less cumbersome tracking system which can easily be used by the surgeon during various surgical procedures.
.
.
, .
Summary of the Invention The present invention relates to handheld tracking systems and devices comprising of at ' least one handheld tracking device for infra-operative aligning or positioning of Surgical implant systems and instruments with reference to the anatomy of a patient. X
present invention also provides process of minimally invasive surgical tracking wi the sterile environment using the systems and devices of the present invention . .
. .
Accordingly, the present invention provides handheld tracking system for infra-..
operative alignment of surgical instruments and/ or implant system. The handheld tracking system comprises of at least one handheld device which has means for input of data, processing means, storage means and means for output, of processed data, rechargeable source of power. The handheld tracking system further comprises of at =
=
least one trackable element, and at least one holding means, which is used for securing .
the handheld device in sterile environment. .
=
Thelandheld device loaded with pre-operative scan data and other patient specific data, . .
is placed or mounted at the proposed implantation site with the help of holding means "
= _ while trackable element(s) are mounted at predetermined location(s). The data from the deployed trackable element(s) relating to the position of the patient and the surgical instruments are input continuously to the handheld device through the means for input, .
and further continuously processed on the basis of the pre-loaded preoperative scanned =
images in the processing means, to provide continuous processed data to monitor the .
accurate placement of the implant system onsite in sterile environment.
=
In another aspect of invention, present invention also discloses the method of using .
handheld tracking system. The method may comprise the step of uploading patient specific preoperative scans and patient specific data in the handheld device.
Additionally, method may include the uploading position data of the trackable element =. positioned on the head of femur to said handheld device to prevent any length = =
= CA 02871997 2014-10-29 P-504'CT-2 REPLACEMENT SHEET
I
. .
Al It is yet another object of the invention to provide cost effective and less cumbersome tracking system which can easily be used by the surgeon during various surgical procedures.
.
.
, .
Summary of the Invention The present invention relates to handheld tracking systems and devices comprising of at ' least one handheld tracking device for infra-operative aligning or positioning of Surgical implant systems and instruments with reference to the anatomy of a patient. X
present invention also provides process of minimally invasive surgical tracking wi the sterile environment using the systems and devices of the present invention . .
. .
Accordingly, the present invention provides handheld tracking system for infra-..
operative alignment of surgical instruments and/ or implant system. The handheld tracking system comprises of at least one handheld device which has means for input of data, processing means, storage means and means for output, of processed data, rechargeable source of power. The handheld tracking system further comprises of at =
=
least one trackable element, and at least one holding means, which is used for securing .
the handheld device in sterile environment. .
=
Thelandheld device loaded with pre-operative scan data and other patient specific data, . .
is placed or mounted at the proposed implantation site with the help of holding means "
= _ while trackable element(s) are mounted at predetermined location(s). The data from the deployed trackable element(s) relating to the position of the patient and the surgical instruments are input continuously to the handheld device through the means for input, .
and further continuously processed on the basis of the pre-loaded preoperative scanned =
images in the processing means, to provide continuous processed data to monitor the .
accurate placement of the implant system onsite in sterile environment.
=
In another aspect of invention, present invention also discloses the method of using .
handheld tracking system. The method may comprise the step of uploading patient specific preoperative scans and patient specific data in the handheld device.
Additionally, method may include the uploading position data of the trackable element =. positioned on the head of femur to said handheld device to prevent any length = =
4 =
. , .
. .
. . . .
. = .
AMENDED SHEET - IPEA/US
= CA 02871997 2014-10-29 TliiMilagAlf 41,1 ti"9 14 14 P-50-PCT-2 REPLACEMENT SHEET =
=
Fig. 2,3 and Fig. 4 depict detailed illuStration of handheld tracking device.
Fig 13, Fig 9 .
and Fig 10 and Fig. 11 depict the method of use of handheld tracking system in arthroplasty iurgery. .
The handheld tracking system as shown in Fig. 9 comprising of one handheld device (2) and trackable element (3200). The handheld device is mounted on the anatomy of patient body (800) by holding means (1027) while trackable element (3200) which is readable by said handheld device is mounted on the surgical instrument (1004) through slot (3101). The said trackable element (3200) may be either made of reflected material or have unique colors. The trackable element (3200) is secured on to the surgical instrument (1004) through means (3101) in such a manner that device (2) can easily detect the trackable element (3201).
=
The handheld device may comprise of processors, rechargeable or single use battery, ,15 speakers, touch screen displays, camera sensors, accelerometer sensors, gyro sensors, flashlights, etc. Said sensors present in the handheld device are capable of communicating with each other or with_the surgical team without any external device or = reference and are capable of detecting and displaying runtime implant system information with-in the sterile environment. = =
. .
- =
.
Figs. 2, 3 and. 4 are directed towards the detailed illustrations of exemplary handheld -tracking device. The said handheld device comprises of display -screen (300), digital -=
cameras (200A, 200B) on.the front and rear side of handtielddevicerespectiv.ely; buiit=in , =
speakers (400), built in flashlights (500, 501) on the front and rear side of the handheld -device respectively. The handheld device also comprises of. digital memory in order to store the preoperative as well as intra-operative data that are useful in the various stages of surgeries.
The digital cameras (200A, 2003) have sensor(s) for capturing image, processor(s) to process the captured image and results are displayed on the said display screen (300).
The display screen can also be a touch screen which can be used as input to record the initial desired position of the trackable element (201) by the surgeon. The display screen displays initial (201) as well as current dynamic position (220) of trackable element. The = =
AMENDED SHEET - IPEA/US =
handheld device recognizes the tracker shape and using image processing displays the boundary of the tracker system (210) which may be circle(s), square(s) or ellipse(s). The display screen may also provide the information indicating the relative difference (310) between said initial and current position of trackable element in reference to a specific surgical step in surgery. The said information is quite useful in surgical procedure, for example in total hip arthroplasty, as it indicates the position of acetabular cup, anteversion, inclination, depth of reaming etc.
The built-in speaker (400) of the said handheld device (1, 2) can provide specific feedback during surgery such as confirmation sound or out of limit "warning beep".
The built-in flash lights (500, 501) with the built-in cameras (200A, 200B) can accurately capture trackable element (2500, 3200, 3300, 3500) positions even with a complex background.
In the arthroplasty surgery the systems and the devices of the present invention can be easily placed in a sterile zone. Fig. 4 describes the device holder to hold the handheld device (1, 2), inside the sterile environment. The said device holder (1020) may include reusable or disposable transparent sterile bag.
Fig. 5 depicts the mounting arrangement (1025, 1026, 1027) of handheld device (2) on to the anatomy or bone of the patient (800). It comprises of assembly of instrument (1025), sterile sleeve (1026) and sterile pin (1027).
Figs. 5 describes holding means of handheld device (2) on to the patient's anatomy. The one side of said sterile pin or screw (1027) is connected to the patient's anatomy or bone (800) while the other side is connected to device holder (1020). The sterile pin or screw (1027) is kept inside the sterile sleeve (1026) such that the sterile pin can be inserted into the patient bone (800) even in the non-sterile environment, thereby allowing the surgeon to position the device at any desired location prior and/or during the surgery.
Fig. 6 also describes another such holding mechanism of handheld tracking device (2) on to the patient's anatomy. The said device holder (2000) consists of a base (2010) which is shaped to match the handheld device (2) for a secured fit (2030). The said device holder t1.90iicil 4 I
(2000) also has a door like mechanism (2020) such that it can hinge with the said base of device holder (2010) to form a close and secure enclosure thereby protecting the handheld device (2). The base Of the device holder (2010) may have an opening (2031) to ensure the = =
proper functioning of the camera / sensors of the hand held device (2). The handheld (2) device could be mounted onto the bone via assembly of device holder (2000) and the pin =
(1027)secured through (1100)screw mechanism.
Figs, 1A, 1B, 7 and 8 depicts the handheld tracking system and devices in sterile environment in which at least one handheld devices (1, 2) are illustrated. These handheld devices are placed around the surgical instruments and /or the patients' anatomy within easy view of the operating surgeon or their assistants. For instance where more than one handheld devices are used, the handheld device (1) may be placed near or secured on the surgical instrument (1000, 1003) while other handheld device (2) may be placed near or mounted on the patient's anatomy (800). The handheld device (2) may be secured to the anatomy or bone of the patient via holding device(1030) or assembly of (1020-1025-1026-1027 or 1027-2000).
The patient is positioned on the flat surface, (1010) of the surgical table which has grids and/or marks (1011) which acts as trackable elements to facilitate initial calibration with the handheld devices for tracking of the patient's position during the surgery.
The bidirectional data communication happens between device 1 channel (600) and device 2 channel (700) .
Fig. 7 illustrates the arrangement of at least one of the trackable elements (3500, 2500) in same or different planes on their respective handheld devices (1, 2). The trackable elements are made of either reflective .material or have Unique color enabling camera sensor to easily identify the elements. Fig. 7, Fig 1B also show the axis (1002) of the surgical instrument (1003) whose position is to be tracked during the surgery relative to patient anatomy (800) for accurate surgical outcome.
Fig 8 shows another detailed view of the arrangement described in Fig. 7. It shows device holder (3000) similar in construction to device holder (2000 and/ or 1020).
The said. device 3-0 holder (3000) of the handheld device (1) has a door like mechanism (3020) such that it can hinge with the said base of device holder (3030) to form a close and secure enclosure thereby protecting the handheld device (1). The base= of the device holder (3030) May have an opening (3031) to ensure the proper functioning of the camera / sensors of the handheld device (1).
=
=
== =
= AMENDED SHEET - IPEA/US
=
PCT/1B13/53441 03-03-2014 FiNligg3406iiii)1.131:9013ou1 4 = P-50-PCT-2 REPLACEMENT SHEET
=
Fig 12 shows in detail preferred method of using handheld tracking system which = includes the steps of uploading of patient specific preoperative scans in the handheld device (1,2), uploading of additional patient-specific data by the surgeon in said = handheld 'device, uploading position data of the trackable element (2700) positioned on the head of femur to said handheld device to prevent any length discrepancy *in leg = length of the patient on completion of surgery, mounting of handheld device on to the patient anatomy/bone and securing the same with said holding means, positioning of at least one trackable element (2500, 3200, 3300,3500),on to the surgical instrument, aligning the patient with preoperative scan stored on to said handheld device to determine the desired position of the implant system mounting of anatomically matched patient specific block (810) on to the surgical instrument, aligning it to the preoperative scan and fixing the desired position of implant as reference position on said display means of said handheld device, dynamically tracking the surgical instruments in relation to said identified reference position to ascertain the correct course of surgery and the .
subsequent implantation of the implant system Examples . In an exemplary embodiment, the present invention provides the use of handheld . =tracking system and devices for hip. arthroplasty. . Hip arthroplasty is - a surgical procedure in which the hip joint is replaced by a prosthetic implant system, which includes a cup placement On the acetabultun (socket) side and step placement on = . =.. =
=
- == - .
=
the femur (ball) side. Hip arthroplasty can be performed as a total replacement or a = .
. _ =
hemi (half) replacement. Such arthroplasty prOtedure is generally conducted to relieve arthritic pain or to fix severe physical joint damage as part of hip fracture treatment.
Generally the cup placement procedure is divided into two or three stages depending upon the type of implant used. In case of cemented cup implant, the acetabultun is reamed using a reamer as a first step and then a cup is placed along with cement. While in un-cemented press-fit implant, the acetabulum is reamed and then the cup is press-fitted onto the bone using an impaction tool.
The hip arthroplasty surgery usually starts with preoperative scan, which may be X-Ray, = CT scan or MRI scans in order to assess the acetabular depth, size and anatomical =
= 10 =
= = AMENDED SHEET -IPEA/US
PCT/I1313/53441 03-03-2014 IfC9A-g MagaiifiA./01:901i el P-50-PCT-2 REPLACEMENT SHEET .
911: landmarks. The preoperative scan also aids in the selection of the most favorable = implant size suitable for the patient anatomy. After this step relevant patient data is transferred and/or stored into the handheld device.
=
' 5 During surgery, the handheld device (2) is mounted rigidly on to the pelvis bone .(800) =
= while trackable element (3200) is mounted on to the surgical instrument such as reamer as shown in Fig 9. The camera sensor (200A) of the handheld device (2) captures the =
desired position of the trackable element (3200) and/or instrument axis (1002) of instrument (1003, 1004). This captured position could be optimized using either pre-op data, anatomically matched block (810) or surgeon's intra-operative clinical judgment.
This captured information is processed and displayed (201) onto the screen (300) of the =
handheld device (2).
Once this desired position is approved by the surgeon, the handheld device guides the surgeon in the subsequent surgical steps to reproduce the planned/desired/approved instrument axis. For example, during the reaming procedure multiple sizes of reamers =
are used to prepare the acetabulum. The handheld device displays the desired position as well as the current 'dynamic position of the trackable element (3200) and/or instrument (1004) as shown in Fig. 9 and Fig 1B. This allows the surgeon to correct the 'position of the surgical instrument and to go back to the pre-identified desired position repeatedly during the entire procedure of reaming and impaction, resulting in accurate acetabular implant component placement.
In another embodiment, the trackable eleme.nt mounted on instrument (1004) has defined dimensions. The handheld device (2) is capable of processing the trackable element image (201) and recognizing it as object(s) with specific dimensions which may be in the form of circle(s), ellipse(s) or square(s) etc. This allows the handheld device (2) to indicate critical information such as angles, distances, diameters etc. For example, Fig 10 shows two circular trackable elements (3200, = 3300) of defined dimension that indicates depth of reaming.
In yet another embodiment, the trackable element (2700) can be mounted on to one bone and the handheld device can be mounted on to another bone. The handheld tracking =
= 11 AMENDED SHEET - IPEA/US
system in this situation can help accurately position the implant system and thereby also accurately align the relative position of the bones in a joint. For example, in hip arthroplasty procedure, Fig 11 shows a simple trackable element (2700) which is affixed onto the femur bone (801) using a small button type tracker or simply by using methylene blue pen to mark a specific area during surgery. This trackable element/mark can be detected by the camera (200B) mounted on pelvis bone (800) and the processed image of this trackable element (215) is displayed onto handheld device (2).
This trackable element position can be initially recorded by the surgeon before opening the joint. This position can be used at a later stage during stem and cup placement to accurately incorporate the leg length required for that patient.
Although the process described above is used for hip arthroplasty, the process of the present invention can be modified and adapted for other surgical procedures where recreation of patient anatomy is critical. Such surgical procedures may include, but are not limited to knee arthroplasty, hip arthroplasty, shoulder arthroplasty, wrist arthroplasty, ankle arthroplasty, spinal surgeries, and osteotomies.
The handheld tracking system of the present invention is able to accurately detect position of implant system and / or surgical instrument with respect to the native anatomy of the patient body without using any external reference from outside the sterile area. The handheld tracking system of the present invention does not require to be in the line-of-sight of any reference outside the sterile area.
Thus, the present invention provides simple, easy to set up, cost effective and less cumbersome surgical navigation systems and devices which can be easily used by a surgeon during various surgical procedures.
. , .
. .
. . . .
. = .
AMENDED SHEET - IPEA/US
= CA 02871997 2014-10-29 TliiMilagAlf 41,1 ti"9 14 14 P-50-PCT-2 REPLACEMENT SHEET =
=
Fig. 2,3 and Fig. 4 depict detailed illuStration of handheld tracking device.
Fig 13, Fig 9 .
and Fig 10 and Fig. 11 depict the method of use of handheld tracking system in arthroplasty iurgery. .
The handheld tracking system as shown in Fig. 9 comprising of one handheld device (2) and trackable element (3200). The handheld device is mounted on the anatomy of patient body (800) by holding means (1027) while trackable element (3200) which is readable by said handheld device is mounted on the surgical instrument (1004) through slot (3101). The said trackable element (3200) may be either made of reflected material or have unique colors. The trackable element (3200) is secured on to the surgical instrument (1004) through means (3101) in such a manner that device (2) can easily detect the trackable element (3201).
=
The handheld device may comprise of processors, rechargeable or single use battery, ,15 speakers, touch screen displays, camera sensors, accelerometer sensors, gyro sensors, flashlights, etc. Said sensors present in the handheld device are capable of communicating with each other or with_the surgical team without any external device or = reference and are capable of detecting and displaying runtime implant system information with-in the sterile environment. = =
. .
- =
.
Figs. 2, 3 and. 4 are directed towards the detailed illustrations of exemplary handheld -tracking device. The said handheld device comprises of display -screen (300), digital -=
cameras (200A, 200B) on.the front and rear side of handtielddevicerespectiv.ely; buiit=in , =
speakers (400), built in flashlights (500, 501) on the front and rear side of the handheld -device respectively. The handheld device also comprises of. digital memory in order to store the preoperative as well as intra-operative data that are useful in the various stages of surgeries.
The digital cameras (200A, 2003) have sensor(s) for capturing image, processor(s) to process the captured image and results are displayed on the said display screen (300).
The display screen can also be a touch screen which can be used as input to record the initial desired position of the trackable element (201) by the surgeon. The display screen displays initial (201) as well as current dynamic position (220) of trackable element. The = =
AMENDED SHEET - IPEA/US =
handheld device recognizes the tracker shape and using image processing displays the boundary of the tracker system (210) which may be circle(s), square(s) or ellipse(s). The display screen may also provide the information indicating the relative difference (310) between said initial and current position of trackable element in reference to a specific surgical step in surgery. The said information is quite useful in surgical procedure, for example in total hip arthroplasty, as it indicates the position of acetabular cup, anteversion, inclination, depth of reaming etc.
The built-in speaker (400) of the said handheld device (1, 2) can provide specific feedback during surgery such as confirmation sound or out of limit "warning beep".
The built-in flash lights (500, 501) with the built-in cameras (200A, 200B) can accurately capture trackable element (2500, 3200, 3300, 3500) positions even with a complex background.
In the arthroplasty surgery the systems and the devices of the present invention can be easily placed in a sterile zone. Fig. 4 describes the device holder to hold the handheld device (1, 2), inside the sterile environment. The said device holder (1020) may include reusable or disposable transparent sterile bag.
Fig. 5 depicts the mounting arrangement (1025, 1026, 1027) of handheld device (2) on to the anatomy or bone of the patient (800). It comprises of assembly of instrument (1025), sterile sleeve (1026) and sterile pin (1027).
Figs. 5 describes holding means of handheld device (2) on to the patient's anatomy. The one side of said sterile pin or screw (1027) is connected to the patient's anatomy or bone (800) while the other side is connected to device holder (1020). The sterile pin or screw (1027) is kept inside the sterile sleeve (1026) such that the sterile pin can be inserted into the patient bone (800) even in the non-sterile environment, thereby allowing the surgeon to position the device at any desired location prior and/or during the surgery.
Fig. 6 also describes another such holding mechanism of handheld tracking device (2) on to the patient's anatomy. The said device holder (2000) consists of a base (2010) which is shaped to match the handheld device (2) for a secured fit (2030). The said device holder t1.90iicil 4 I
(2000) also has a door like mechanism (2020) such that it can hinge with the said base of device holder (2010) to form a close and secure enclosure thereby protecting the handheld device (2). The base Of the device holder (2010) may have an opening (2031) to ensure the = =
proper functioning of the camera / sensors of the hand held device (2). The handheld (2) device could be mounted onto the bone via assembly of device holder (2000) and the pin =
(1027)secured through (1100)screw mechanism.
Figs, 1A, 1B, 7 and 8 depicts the handheld tracking system and devices in sterile environment in which at least one handheld devices (1, 2) are illustrated. These handheld devices are placed around the surgical instruments and /or the patients' anatomy within easy view of the operating surgeon or their assistants. For instance where more than one handheld devices are used, the handheld device (1) may be placed near or secured on the surgical instrument (1000, 1003) while other handheld device (2) may be placed near or mounted on the patient's anatomy (800). The handheld device (2) may be secured to the anatomy or bone of the patient via holding device(1030) or assembly of (1020-1025-1026-1027 or 1027-2000).
The patient is positioned on the flat surface, (1010) of the surgical table which has grids and/or marks (1011) which acts as trackable elements to facilitate initial calibration with the handheld devices for tracking of the patient's position during the surgery.
The bidirectional data communication happens between device 1 channel (600) and device 2 channel (700) .
Fig. 7 illustrates the arrangement of at least one of the trackable elements (3500, 2500) in same or different planes on their respective handheld devices (1, 2). The trackable elements are made of either reflective .material or have Unique color enabling camera sensor to easily identify the elements. Fig. 7, Fig 1B also show the axis (1002) of the surgical instrument (1003) whose position is to be tracked during the surgery relative to patient anatomy (800) for accurate surgical outcome.
Fig 8 shows another detailed view of the arrangement described in Fig. 7. It shows device holder (3000) similar in construction to device holder (2000 and/ or 1020).
The said. device 3-0 holder (3000) of the handheld device (1) has a door like mechanism (3020) such that it can hinge with the said base of device holder (3030) to form a close and secure enclosure thereby protecting the handheld device (1). The base= of the device holder (3030) May have an opening (3031) to ensure the proper functioning of the camera / sensors of the handheld device (1).
=
=
== =
= AMENDED SHEET - IPEA/US
=
PCT/1B13/53441 03-03-2014 FiNligg3406iiii)1.131:9013ou1 4 = P-50-PCT-2 REPLACEMENT SHEET
=
Fig 12 shows in detail preferred method of using handheld tracking system which = includes the steps of uploading of patient specific preoperative scans in the handheld device (1,2), uploading of additional patient-specific data by the surgeon in said = handheld 'device, uploading position data of the trackable element (2700) positioned on the head of femur to said handheld device to prevent any length discrepancy *in leg = length of the patient on completion of surgery, mounting of handheld device on to the patient anatomy/bone and securing the same with said holding means, positioning of at least one trackable element (2500, 3200, 3300,3500),on to the surgical instrument, aligning the patient with preoperative scan stored on to said handheld device to determine the desired position of the implant system mounting of anatomically matched patient specific block (810) on to the surgical instrument, aligning it to the preoperative scan and fixing the desired position of implant as reference position on said display means of said handheld device, dynamically tracking the surgical instruments in relation to said identified reference position to ascertain the correct course of surgery and the .
subsequent implantation of the implant system Examples . In an exemplary embodiment, the present invention provides the use of handheld . =tracking system and devices for hip. arthroplasty. . Hip arthroplasty is - a surgical procedure in which the hip joint is replaced by a prosthetic implant system, which includes a cup placement On the acetabultun (socket) side and step placement on = . =.. =
=
- == - .
=
the femur (ball) side. Hip arthroplasty can be performed as a total replacement or a = .
. _ =
hemi (half) replacement. Such arthroplasty prOtedure is generally conducted to relieve arthritic pain or to fix severe physical joint damage as part of hip fracture treatment.
Generally the cup placement procedure is divided into two or three stages depending upon the type of implant used. In case of cemented cup implant, the acetabultun is reamed using a reamer as a first step and then a cup is placed along with cement. While in un-cemented press-fit implant, the acetabulum is reamed and then the cup is press-fitted onto the bone using an impaction tool.
The hip arthroplasty surgery usually starts with preoperative scan, which may be X-Ray, = CT scan or MRI scans in order to assess the acetabular depth, size and anatomical =
= 10 =
= = AMENDED SHEET -IPEA/US
PCT/I1313/53441 03-03-2014 IfC9A-g MagaiifiA./01:901i el P-50-PCT-2 REPLACEMENT SHEET .
911: landmarks. The preoperative scan also aids in the selection of the most favorable = implant size suitable for the patient anatomy. After this step relevant patient data is transferred and/or stored into the handheld device.
=
' 5 During surgery, the handheld device (2) is mounted rigidly on to the pelvis bone .(800) =
= while trackable element (3200) is mounted on to the surgical instrument such as reamer as shown in Fig 9. The camera sensor (200A) of the handheld device (2) captures the =
desired position of the trackable element (3200) and/or instrument axis (1002) of instrument (1003, 1004). This captured position could be optimized using either pre-op data, anatomically matched block (810) or surgeon's intra-operative clinical judgment.
This captured information is processed and displayed (201) onto the screen (300) of the =
handheld device (2).
Once this desired position is approved by the surgeon, the handheld device guides the surgeon in the subsequent surgical steps to reproduce the planned/desired/approved instrument axis. For example, during the reaming procedure multiple sizes of reamers =
are used to prepare the acetabulum. The handheld device displays the desired position as well as the current 'dynamic position of the trackable element (3200) and/or instrument (1004) as shown in Fig. 9 and Fig 1B. This allows the surgeon to correct the 'position of the surgical instrument and to go back to the pre-identified desired position repeatedly during the entire procedure of reaming and impaction, resulting in accurate acetabular implant component placement.
In another embodiment, the trackable eleme.nt mounted on instrument (1004) has defined dimensions. The handheld device (2) is capable of processing the trackable element image (201) and recognizing it as object(s) with specific dimensions which may be in the form of circle(s), ellipse(s) or square(s) etc. This allows the handheld device (2) to indicate critical information such as angles, distances, diameters etc. For example, Fig 10 shows two circular trackable elements (3200, = 3300) of defined dimension that indicates depth of reaming.
In yet another embodiment, the trackable element (2700) can be mounted on to one bone and the handheld device can be mounted on to another bone. The handheld tracking =
= 11 AMENDED SHEET - IPEA/US
system in this situation can help accurately position the implant system and thereby also accurately align the relative position of the bones in a joint. For example, in hip arthroplasty procedure, Fig 11 shows a simple trackable element (2700) which is affixed onto the femur bone (801) using a small button type tracker or simply by using methylene blue pen to mark a specific area during surgery. This trackable element/mark can be detected by the camera (200B) mounted on pelvis bone (800) and the processed image of this trackable element (215) is displayed onto handheld device (2).
This trackable element position can be initially recorded by the surgeon before opening the joint. This position can be used at a later stage during stem and cup placement to accurately incorporate the leg length required for that patient.
Although the process described above is used for hip arthroplasty, the process of the present invention can be modified and adapted for other surgical procedures where recreation of patient anatomy is critical. Such surgical procedures may include, but are not limited to knee arthroplasty, hip arthroplasty, shoulder arthroplasty, wrist arthroplasty, ankle arthroplasty, spinal surgeries, and osteotomies.
The handheld tracking system of the present invention is able to accurately detect position of implant system and / or surgical instrument with respect to the native anatomy of the patient body without using any external reference from outside the sterile area. The handheld tracking system of the present invention does not require to be in the line-of-sight of any reference outside the sterile area.
Thus, the present invention provides simple, easy to set up, cost effective and less cumbersome surgical navigation systems and devices which can be easily used by a surgeon during various surgical procedures.
Claims (14)
1. Handheld tracking system for intraoperative alignment of surgical instruments and/ or implant system, said system comprising of ;
¨ at least one handheld device (1, 2), having means for input of data (200A, 200B, 300), processing means, storage means and means for output (300, 400) of processed data, rechargeable source of power, said handheld device being loaded with patient specific preoperative scanned images as well as other patient specific data, ¨ at least one trackable element_(1011, 2500, 3200, 3300,3500), mounted on predetermined locations ¨ at least one holding means (1020, 1030, 1027, 1025, 1026), for securing said handheld device in sterile environment, said handheld device capable of being placed at the proposed implantation site in a manner that all said trackable elements are capable of being monitored on said handheld device such that data from said deployed trackable element(s) relating to the position of the patient and the surgical instruments is input continuously through the means for input, said data being processed on the basis of said pre-loaded preoperative scanned images and said patient specific information to provide continuous processed data to monitor the accurate placement of said implant system onsite in sterile environment.
¨ at least one handheld device (1, 2), having means for input of data (200A, 200B, 300), processing means, storage means and means for output (300, 400) of processed data, rechargeable source of power, said handheld device being loaded with patient specific preoperative scanned images as well as other patient specific data, ¨ at least one trackable element_(1011, 2500, 3200, 3300,3500), mounted on predetermined locations ¨ at least one holding means (1020, 1030, 1027, 1025, 1026), for securing said handheld device in sterile environment, said handheld device capable of being placed at the proposed implantation site in a manner that all said trackable elements are capable of being monitored on said handheld device such that data from said deployed trackable element(s) relating to the position of the patient and the surgical instruments is input continuously through the means for input, said data being processed on the basis of said pre-loaded preoperative scanned images and said patient specific information to provide continuous processed data to monitor the accurate placement of said implant system onsite in sterile environment.
2. Handheld tracking system as claimed in claim 1 wherein said means for input is a combination of devices selected from at least one digital camera (200A, 200B), multiple sensors, touch screen, touchpad, keyboard, voice input system.
3. Handheld tracking system as claimed in claim 1 wherein said means for output is a combination selected from display means, audio means, audiovisual means, touch screen which is capable of providing runtime information including initial input by surgeon, recording specific position and measure specific angle of said surgical instrument during various surgical steps.
4. Handheld tracking system as claimed in claim 2 wherein said multiple sensors includes inbuilt digital camera sensor, gyro meter sensor, accelerometer sensors.
5. Handheld tracking system as claimed in claim 1 wherein predetermined locations of the trackable elements are selected from the bone such as femur bone head and/or surgical instruments deployed in the surgery.
6. Handheld tracking system as claimed in claim 1 wherein said trackable element is selected from reflective material, material of unique color, methyl bluemarker, button and such other elements that allows said sensor to detect the position of said trackable element accurately.
7. Handheld tracking system as claimed in claim-1 wherein said handheld device is placed by itself at positions, or secured with holding means selected from holding device (1030), holding assembly (1025-1027-1030) with device holder (1020) having slots (1100), and sterile pin (1027) for fixing device holder (1020) having slots (1100).
8. Handheld tracking system ai claimed in claim 7 wherein said holding assembly comprises of holding instrument (1025) that is connected to said device holder (1020), removable sterile sleeve (1026) and sterile pin (1027), such that said holding instrument (1025) is placed within said removable sterile sleeve (1026) and fixed on location using sterile pin (1027).
9. Handheld tracking system as claimed in claim 7 wherein said sterile pin (1027) directly connects said device holder (1020) of the handheld device to the bone of the patient.
10. Handheld tracking system as claimed in claim 7, wherein holding device (1030) rigidly connects the handheld device to the anatomy of the patient.
11. Handheld tracking system as claimed in claim 7, wherein device holder is sterile bag having slots.
12. Handheld tracking system as claimed in claim 1 wherein said handheld device has rechargeable battery.
13. Handheld tracking system for intraoperative alignment of surgical instruments and/ or implant system as claimed in claim 1 wherein said system comprises of more than one handheld device (1, 2) each being capable of communicating wirelessly to the other using data communication link or protocol without any external device or reference.
14. The method of using handheld tracking system for aligning surgical instruments/implant system, said method comprising the steps of:
- uploading patient specific preoperative scans in the handheld device (1,2), - uploading of additional patient-specific data by the Surgeon in said handheld device (1,2), - uploading position data of the trackable element (2700) positioned on the head of femur to said handheld device to prevent any length discrepancy in leg length of the patient on completion of surgery, placing said handheld device near the patient or mounting said handheld device on to the patient anatomy/bone and securing the same with said holding means (1920, 1030, 1025, 1026,1027), positioning of at least one trackable element (200) on to the surgical instrument (1904), Aligning the patient on flat surface of trackable surgical table (1011) with preoperative scan stored on to said handheld device to determine the desired position of the implant system, mounting of anatomically matched patient specific block (810) on to the surgical instrument, aligning it to the preoperative scan and fixing the desired position of implant as reference position (201) on said display means (300) of said handheld device, - dynamically tracking the surgical instruments in relation to said identified reference position to ascertain the correct course of surgery and the subsequent implantation of the implant system.
- uploading patient specific preoperative scans in the handheld device (1,2), - uploading of additional patient-specific data by the Surgeon in said handheld device (1,2), - uploading position data of the trackable element (2700) positioned on the head of femur to said handheld device to prevent any length discrepancy in leg length of the patient on completion of surgery, placing said handheld device near the patient or mounting said handheld device on to the patient anatomy/bone and securing the same with said holding means (1920, 1030, 1025, 1026,1027), positioning of at least one trackable element (200) on to the surgical instrument (1904), Aligning the patient on flat surface of trackable surgical table (1011) with preoperative scan stored on to said handheld device to determine the desired position of the implant system, mounting of anatomically matched patient specific block (810) on to the surgical instrument, aligning it to the preoperative scan and fixing the desired position of implant as reference position (201) on said display means (300) of said handheld device, - dynamically tracking the surgical instruments in relation to said identified reference position to ascertain the correct course of surgery and the subsequent implantation of the implant system.
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| IN1345/DEL/2012 | 2012-05-02 | ||
| PCT/IB2013/053441 WO2013164770A2 (en) | 2012-05-02 | 2013-05-01 | Handheld tracking systems and devices for aligning implant systems during surgery |
| IN1345DE2012 IN2012DE01345A (en) | 2012-05-02 | 2013-05-01 |
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| EP (1) | EP2844180A4 (en) |
| JP (1) | JP2015516228A (en) |
| KR (1) | KR20150014442A (en) |
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| IN (1) | IN2012DE01345A (en) |
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| US9247998B2 (en) | 2013-03-15 | 2016-02-02 | Intellijoint Surgical Inc. | System and method for intra-operative leg position measurement |
| AU2015337755B2 (en) * | 2014-10-29 | 2019-07-25 | Intellijoint Surgical Inc. | Systems, methods and devices for anatomical registration and surgical localization |
| DE102015102776A1 (en) | 2015-02-26 | 2016-09-01 | Aesculap Ag | Medical instruments and procedures |
| DE102015102768A1 (en) | 2015-02-26 | 2016-09-01 | Aesculap Ag | Medical Instrument |
| EP3313318A1 (en) * | 2015-06-23 | 2018-05-02 | Matrix It Medical Tracking Systems, Inc. | Sterile implant tracking device and system |
| CA2989290C (en) | 2015-06-28 | 2019-04-02 | S & S Innovations, LLC | Tracking patient information and medical device identifier |
| US11045174B2 (en) | 2015-09-25 | 2021-06-29 | Covidien Lp | Patient movement sensor |
| DE102016115605A1 (en) | 2016-08-23 | 2018-03-01 | Aesculap Ag | Medical instruments and procedures |
| EP3565497A1 (en) * | 2017-01-04 | 2019-11-13 | Medivation AG | A mobile surgical tracking system with an integrated fiducial marker for image guided interventions |
| CN107088091A (en) * | 2017-06-08 | 2017-08-25 | 广州技特电子科技有限公司 | The operation guiding system and air navigation aid of a kind of auxiliary bone surgery |
| DE102017122143A1 (en) | 2017-09-25 | 2019-03-28 | Aesculap Ag | Medical-technical deformation device, deformation system and method for deforming an article |
| CN114007525A (en) * | 2019-06-21 | 2022-02-01 | 马尼什·沙阿 | Clamp for guiding placement of glenoid component of implant in shoulder arthroplasty |
| EP4076251A1 (en) * | 2019-12-16 | 2022-10-26 | Intuitive Surgical Operations, Inc. | Systems for facilitating guided teleoperation of a non-robotic device in a surgical space |
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| US20070015999A1 (en) * | 2005-07-15 | 2007-01-18 | Heldreth Mark A | System and method for providing orthopaedic surgical information to a surgeon |
| US20070167741A1 (en) * | 2005-12-30 | 2007-07-19 | Sherman Jason T | Apparatus and method for registering a bone of a patient with a computer assisted orthopaedic surgery system |
| WO2008151446A1 (en) * | 2007-06-15 | 2008-12-18 | Orthosoft Inc. | Computer-assisted surgery system and method |
| EP2209526A1 (en) * | 2007-11-15 | 2010-07-28 | Koninklijke Philips Electronics N.V. | Method and apparatus for positional tracking of a therapeutic ultrasound transducer |
| US9248000B2 (en) * | 2008-08-15 | 2016-02-02 | Stryker European Holdings I, Llc | System for and method of visualizing an interior of body |
| US20100137871A1 (en) * | 2008-09-10 | 2010-06-03 | OrthAlign, Inc. | Hip surgery systems and methods |
| EP2455038B1 (en) * | 2008-10-21 | 2015-04-01 | Brainlab AG | Integration of surgical instrument and display device for supporting image led surgery |
| CA2766341C (en) * | 2009-06-26 | 2020-03-24 | Cianna Medical, Inc. | Apparatus, systems, and methods for localizing markers or tissue structures within a body |
| WO2011020505A1 (en) * | 2009-08-20 | 2011-02-24 | Brainlab Ag | Integrated surgical device combining instrument; tracking system and navigation system |
| AU2011239570A1 (en) * | 2010-04-14 | 2012-11-01 | Smith & Nephew, Inc. | Systems and methods for patient- based computer assisted surgical procedures |
| KR101964579B1 (en) * | 2011-02-18 | 2019-04-03 | 디퍼이 신테스 프로덕츠, 인코포레이티드 | Tool with integrated navigation and guidance system and related apparatus and methods |
| US10342619B2 (en) * | 2011-06-15 | 2019-07-09 | Brainlab Ag | Method and device for determining the mechanical axis of a bone |
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- 2013-05-01 CA CA2871997A patent/CA2871997A1/en not_active Abandoned
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| CN104271068A (en) | 2015-01-07 |
| EP2844180A4 (en) | 2015-10-21 |
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| IN2012DE01345A (en) | 2015-08-07 |
| KR20150014442A (en) | 2015-02-06 |
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| EP2844180A2 (en) | 2015-03-11 |
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Effective date: 20180501 |