CN101287408A - Body parameter detecting sensor and method for detecting body parameters - Google Patents
Body parameter detecting sensor and method for detecting body parameters Download PDFInfo
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- CN101287408A CN101287408A CNA2006800144919A CN200680014491A CN101287408A CN 101287408 A CN101287408 A CN 101287408A CN A2006800144919 A CNA2006800144919 A CN A2006800144919A CN 200680014491 A CN200680014491 A CN 200680014491A CN 101287408 A CN101287408 A CN 101287408A
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Abstract
A method for detecting biometric parameters includes the steps of performing a bone graft procedure on a vertebra of a spine, providing a biometric sensor (1-9) at the vertebra (10,20), and measuring a biometric parameter at the vertebra with the sensor. The sensor is capable of measuring parameters in an adjacent surrounding including pressure, tension, shear, relative position, and vascular flow. Data relating to the biometric parameter is transmitted to an external source and the data are analyzed to evaluate a biometric condition of the vertebra. A set of the sensors can be placed on transverse processes (70) of the vertebra.
Description
Technical field
The present invention relates to the medical device field, especially, relate to external and imbed sensing system, it (for example is used to detect physiology, muscle skeleton) the concrete parameter of system and determine active precise anatomical position, and the field that relates to the method that is used to detect the anatomical position parameter.
Background technology
In U.S. Patent No. 6,621, in 278, No.6,856,141 and No.6,984,993 (patents of Ariav and transfer Nexense company, i.e. " patent of Nexense ") sensor technology is disclosed.
Useful is, the existing sensors technology is applied to the biometric data Application in Sensing, and the health care personnel can determine the feature of anatomical position like this.
Summary of the invention
Therefore, the object of the present invention is to provide a kind of sensing system, it (for example can detect concrete parameter, the parameter of musculoskeletal system), and determine active precise anatomical position, and the method that is provided for detecting the parameter of anatomical position, the present invention has overcome the shortcoming of the method for aforesaid disclosed up to now equipment and this common type, and the invention provides applications and/or imbed pick off, so that the real-time information about their patient to be provided to the health care supplier.These information can comprise that pathology is handled and with surgical procedure with implant device-dependent information.These pick offs can start by inside or external agency, and these information are propagated by wireless path.Described sensing system will allow the early stage intervention or the correction of implant system, and can use existing sensors.For example, can use disclosed pick off in the Nexense patent.
Be construed to is that other technical characterictic of feature of the present invention can propose in the dependent claims.
Although the present invention is specifically implementing this illustrate and in the sensing system that is described as can detecting concrete body parameter and determining active precise anatomical position, and method for being used to detect, yet this does not also mean that and is limited to the details that illustrates, this is because under the situation that does not break away from spirit of the present invention, and in the full scope of equivalents and zone of claims, can carry out various remodeling and structural change.
Yet when read in conjunction with the accompanying drawings, structure of the present invention and operational approach and additional purpose thereof and advantage will be better understood by following explanation to specific embodiment together.
Description of drawings
Concrete implement advantage of the present invention and will become apparent by the following detailed description of the preferred embodiment of the present invention, this explanation should consider in conjunction with the accompanying drawings, wherein:
Fig. 1 is the schematic partial side of the part of spinal column, wherein has according to incorporate spinal column and the pick off do not carried out of the present invention;
Fig. 2 is the schematic local front and back view of the spine portion of Fig. 1;
Fig. 3 is the schematic partial side of the part of spinal column, wherein has according to intervertebral skeleton of the present invention and pick off;
Fig. 4 is the schematic local front and back view of the spine portion of Fig. 1, wherein has in pedicle screw according to pick off of the present invention;
Fig. 5 is the schematic partial side of the part of spinal column, wherein has according to intervertebral disc implant of the present invention and pick off;
Fig. 6 is the schematic local amplification profile that inserts instrument according to pick off of the present invention;
That Fig. 7 implants for the instrument by Fig. 6, according to the schematic partial cross-sectional view with last femur of pick off of the present invention;
That Fig. 8 implants for the instrument by Fig. 6, according to the schematic partial cross-sectional view with vertebra of pick off of the present invention;
Fig. 9 is the show in schematic partial sections according to the vertebra with pick off in screw of the present invention;
Figure 10 is the schematic partial cross-sectional view according to the femur of the pick off with implantation of the present invention;
Figure 11 is according to the schematic partial cross-sectional view with vertebra of pick off of the present invention;
Figure 12 is the kneed schematic local front and back profile with pick off according to the present invention;
Figure 13 is according to the kneed schematic local lateral sectional view with pick off of the present invention;
Figure 14 is according to the schematic partial cross-sectional view with hip joint of pick off of the present invention;
Figure 15 is according to the schematic local lateral sectional view with vertebra of pick off of the present invention;
Figure 16 is according to the schematic localized axial profile with vertebra of pick off of the present invention;
Figure 17 is according to the kneed schematic partial cross-sectional view with ultrasound wave active sensor of the present invention;
Figure 18 is ultrasonic transmitter and the sketch map that shows kneed computer screen, and wherein knee joint has the ultrasound wave active sensor of handling according to the present invention;
Figure 19 is according to the schematic amplification profile that is linked to the handle of implantable sensor body of the present invention;
Figure 20 is the schematic amplification profile with the handle of the isolating Figure 19 of sensor body;
Figure 21 is the sketch map of infrared visible system;
Figure 22 is the sketch map of electromagnetism visible system;
Figure 23 is the front view that kneed local part is hidden;
Figure 24 is the side view that kneed local part is hidden;
Figure 25 is the partial side view of ligament;
Figure 26 is the partial side view of the ligament of Figure 25, wherein has according to ligament pick off anchor clamps of the present invention;
Figure 27 is the partial side view of ligament and the ligament pick off anchor clamps of Figure 26;
Figure 28 is the partial side view of the ligament of Figure 25, wherein attached with good grounds pick off of the present invention;
Figure 29 is the part sectioned view according to the part of ultrasonic trocar of the present invention system;
Figure 30 is the part sectioned view according to the part of single-sensor sleeve pipe advancing equipment of the present invention;
Figure 31 is the part sectioned view of a part of the sleeve pipe advancing equipment of Figure 30, wherein has a plurality of pick offs;
Figure 32 is the part sectioned view according to the part of a plurality of sensor sleeve advancing equipments of the present invention;
Figure 33 has wherein removed soft tissue and cartilage for opening the operating partial side view of knee joint, and the pick off cutting of bone by arranging according to the present invention;
Figure 34 is the part sectioned view according to trocar needle point of the present invention, wherein holds sensor element;
Figure 35 is the part sectioned view that is used for the insert of one group of pick off;
Figure 36 is according to the schematic side elevation that holds the sickle of one group of pick off of the present invention;
Figure 37 is the schematic side elevation of bone borer;
Figure 38 is for implanting the part sectioned view of the sensing system in the hip according to the present invention;
Figure 39 is the part sectioned view of the sensing system in the implanted femur according to the present invention;
Figure 40 is the part sectioned view of the bone socket pick off insert that is used to arrange a plurality of pick offs according to the present invention;
Figure 41 is according to the partial cut away side views with two spinal segments of pick off implant system of the present invention; And
Figure 42 is the localized axial profile with vertebra joint of implanting the pick off that passes pedicle of vertebral arch.
The specific embodiment
Many aspects of the present invention are open in the following description and relate to accompanying drawing at specific embodiments of the invention.Can design the alternate embodiment that does not break away from the spirit or scope of the present invention.In addition, the known elements of exemplary embodiment of the present invention will not be described in detail maybe and will be omitted, in order to avoid cause relevant details of the present invention unclear.
Before disclosure and description the present invention, be to be understood that as used herein term only is in order to describe the purpose of special embodiment, rather than in order to limit.Have to be noted that as employed in description and appended claims singulative " ", " one " and " described " comprise plural implication, do not comprise unless spell out in the context.
Although description is summed up to limit claims that are considered to novel characteristics of the present invention, yet, can believe that the present invention will be in conjunction with the drawings be better understood the investigation of following explanation, in the accompanying drawings, similarly continue to use in the Reference numeral accompanying drawing below.Figure in the accompanying drawing illustrates not in scale.
External sensing system according to the present invention can be used to assess skin complete and pathology pressure, and pathology pressure may cause local skin ischemia and final skin weak (decubital ulcer).Importantly detect some and may cause the weak parameter of skin.Key element such as pressure, time, shear and vascular flow is the emphasis for detecting for example.Need concrete anatomical position.
That sensing system of the present invention can be embedded to is thin, that have viscosity, in the compatible material, described material is applied in the concrete region-of-interest.Exemplary area comprises calcaneus, hip, rumpbone and other risk zones.These pick offs are formulated anatomic region.If the parameter of overstepping the extreme limit, then pick off is notified telemetry receiver, thereby starts warning to nurse or other health care professional.In concrete an application, this information is used to control the bed that the patient lies and leans on, to discharge region-of-interest.Particularly, regulate the air bag in the mattress, this can unload injured region-of-interest.
The external sensor system can construct in many ways.In the exemplary embodiment, that pick off is arranged on is thin, in the compatible binding agent, and described binding agent is applied directly on the patient's body, and by thin lithium battery power supply.This pick off provides special parameter, and for example pressure, time, shearing force and blood vessel flow.This pick off remote measurement ground notice receiving element, and if surpass some blas parameter, warning then is set.In one embodiment, provide vision aid (computer screen that for example shows the patient's body profile), then accurate region-of-interest can be more remarkable, thereby and make health care professional visual.
The pick off of imbedding need detect can not be directly by eye-observation to some inner parameter.These pick offs will be used in specific position to detect specific parameter.
A kind of mode of imbedding pick off is that in this surgical procedure, pick off directly is embedded in bone or the soft tissue by the surgeon, perhaps directly is attached on the fixed implant (for example, prosthese (hip, knee)) by the incision surgical procedure.In surgical procedure, use sensing system to notify surgeon's implant and soft tissue balance and/or aligned position and/or function.Pick off has directly been imbedded the instrument of penetrating, pick off is released in the predetermined degree of depth.Pick off is attached to fixed implant by special lock locking system or binding agent.Pick off started before closure, so that pick off comes into force.
The another kind of mode of imbedding pick off is by through picoprogram.The ability that pick off is implanted in the ad-hoc location is extremely important to the assessment built-in system.Can be implanted in bone, soft tissue and/or the implant becoming diameter sensor.This program is used under the visual situation that is for example provided by fluoroscopy, ultrasonic imaging and cat scan.This program can be carried out under part or regional anesthesia's situation.The parameter of these assessments is as the described herein.Comprise the slim instrument with sharp-pointed trocar through dermal system, it thrusts necessary tissue plane, and by arranging that arm is released in predetermined degree of depth place with pick off.This instrument also can hold necessary navigation system and determine required concrete anatomical position.
Parameter to be assessed and time factor determine to imbed the required energy source of pick off.Short-term limit (being no more than 5 years) allows to use battery.Long expiration need advise using external active system or external impetus system, and the kinetic energy that perhaps uses the patient is to provide energy to sensing system.These active systems can be used at present.Pick off also can start at preset time, with the circulation of monitoring implant, mobile unusually and implant wearing and tearing threshold value.
Information is received by remote measurement.In one exemplary embodiment, if surpass certain threshold level, then pick off is programmed is " startup ", and sends required information.Pick off also can be activated and use so that the information repeated transmission is cast to outside receptor.Further use permission " intelligent implant " readjusted to discharge certain drug, biology or other material, perhaps readjust implant and aim at or modularity.
Sensing system initially is activated and is read in doctor's office, and can further start in patient's room, and the patient has the ability of the information that for example sends Xiang the doctor by internet, applications.
Software will be programmed to reception information, process information and diffuse information to the health care supplier subsequently.
Sensing system of the present invention has many different application.For example, can be used for the treatment of osteoporosis.Osteoporosis is the pathological condition of bone, thereby it is characterized in that reducing the risk that the bone amount increases fracture.Be recognized that bone mineral content is relevant with bone strength with bone mineral density.
Bone density is the very important parameter of musculoskeletal system to be assessed.Bone density measurement is used to quantize people's bone strength and the final risk that indicates the increase relevant with osteoporosis.Bone loss causes fracture, spinal column compression and implant loosening.At present, the doctor adopts the externalist methodology such as special-purpose X ray.
The measurement unit that is used for Osteodensitometry is the bone mineral content with the gram expression.In fracture osteoporosis, knitting and by the implant of stress protection in the loosening assessment, it is very important that bone density changes.Another important assessment relates to osteolysis.Osteolysis can be destroyed bone in the mode of tacit declaration.This is to be subjected to the pathological reaction of implantation person to the supporting accessory such as polyethylene.The response of polyethylene particles activate immunity granuloma, originally it influence the bone around the implant.To produce bone density and change before capsula interna changes, this causes serious bone loss and implant to lose efficacy.
Existence can be assessed the multiple external system of bone density.The problem that these systems ran into is relevant with various systems itself, yet also with the patient to be brought into office relevant with the social economy constraint of assessing painless disease, and add that the interval of the Payment Methods of tightening up between causing assessing extend.
Pick off used according to the invention allows the variation of assessment bone density aspect, thereby can make the health care supplier obtain real-time internal data.Application sensors can be evaluated osteolysis and grade and/or response thereof and handle.By the assessment changes of bone mineral density, pick off provides the information that relates to union of fracture in early days and the variation that relates to osteolysis (bone that relates to polyethylene wear in the implant changes) is provided in early days.
Yet, have multiple multi-form device when passing bone and soft tissue, all write down the decay of a beam energy.Result's comparison must be limited to identical shaped bone, constant relation between its supposition bone thickness and the zone that is scanned.In addition, be measured as accurate frame position and determine, thus, only during the same position in the research skeleton, just can carry out individual comparison.
Dual intensity x radiation absorption measurement method can be used for detecting at a plurality of anatomical positions a small amount of variation of bone mineral content.The major defect of technology is that it can not make the examiner distinguish the bone and the trabeculate bone of cortex.Quantitative ultrasound wave is compared with other bone density measurement method of only measuring bone mineral content, can measure the characteristic of the extra bone such as mechanical integrity.Hyperacoustic propagation by bone is subjected to the influence of bone amount, bony structure and loading direction.As the quantitative ultrasonic measurement of the measurement of intensity that is used to evaluate bone and hardness processing based on the ultrasonic signal that is received.Bone and soft tissue are passed in the sound of certain speed and ultrasonic propagation.Prosthetic loosening or sinking are relevant with bone loss with the fracture of femur/tibia/acetabular bone or prosthese.Therefore, the accurate evaluation of the progressive measurable variation of the bone mineral content of Periprosthetic can help the surgeon who is treating to determine when insertion, to keep revising the bone development (bone stock) that the joint forms art.This information helps to be used for the development of the implant of osteoporotic bone, and helps the assessment of the effect of the medical treatment of osteoporosis and different implant coatings.
Sensing system of the present invention can be used to assess the function of inner implant.The current experience of actual implant function is considerably less.The doctor uses externalist methodology continuously, comprises X ray, bone scanning and patient evaluation.Yet the doctor typically only keeps by cutting surgical operation and seeks and visits and carry out the actual functional capability investigation.Utilization pick off according to the present invention is allowed the initial failure of implant and the detection that is about to take place big fault.Like this, can get involved in early days.Thereby reduce patient's sickness rate; Reduce further health care cost; And the quality of life of improving the patient.
Pick off can directly be attached to the surface (in advance implement and/or in interior enforcement) of implant and/or directly be attached to the inner surface of implanting bone.Pick off can be implanted in bone and the soft tissue.In this application, the doctor can assess and implant the important parameter that is subjected to implantation person system.The exemplary parameter that can measure comprises: implant stability, implant move, implant is worn and torn, implant circulation time, implant identification, implant pressure/loading, implant integraty, joint fluid analysis, articular surface information, ligament function and other are more.
Allow people to determine that implant is whether unstable and/or whether take place excessively to move or sink according to the application of pick off of the present invention.In exemplary application, pick off can be configured to discharge normal biological preparation (orthobiologic) from the module of active implantation, to increase integraty.Optionally and/or in addition, the implant system with pick off can be used to regulate angle/skew/soft tissue strain, with stabilisation implant where necessary.
Whether pick off can be used to detect the implant supporting member and wear and tear bad.Detectable supporting member parameter comprises the friction of premature wear, increase etc.Early alert from the warning of pick off can be changed supporting member in early days prior to big fault.
The joint implant pick off can detect the increase of heat, acidity or other physical characteristic.This understanding will provide the early infection warning Xiang the doctor.In the exemplary infections treatment was used, pick off can start the antibiotic module of imbedding of release.
Pick off can be used to analyze the knee joint surgical operation.This pick off can be set in the knee subsequently, with assessment vascular flow, pressure and/or the rhythm and pace of moving things.The internal vessels watch-dog can be the part of implant, and comprises the equipment that discharges antihypertensive drug or arrhythmia medicine (anti-arrthymic) module, to revise the variation of vascular when needed.
In one embodiment, inner orthopaedic implant is originally as pick off of the present invention.Under the wound state, for example, reduction screw can be used as implant and pick off.This helical reactors can detect the increase (that is healing) of mobile unusually and definite density at the fracture place.This application allows into the percutaneous of bone morphogenetic protein (BMP) and implants, to help to heal or the percutaneous of hardware is regulated.
Pick off of the present invention can be used for spine and implant.The pick off that is arranged in spine/vertebra can detect and close the mobile unusually of position.The spine at sensor evaluation adjacent vertebrae sections place is implanted integraty and/or is detected the unstability of adjacent vertebrae sections.The pick off of implanting can start transition stabilisation systems or implant, and determines excessively mobile zone, obtaining percutaneous stability by hardware or normal biological preparation.Diagram in now inciting somebody to action in detail with reference to the accompanying drawings at first, with particular reference to the Fig. 1 in the accompanying drawing, wherein shows a partial side view part and that close of spinal column.Epipyramis 10 separates with following vertebra 20 by intervertebral disc 30.Bone graft 40 is at first covered by inferior articular surface 50, and is covered by superior articular surface 60 subsequently.Fig. 2 is the front and back view of the spine portion of Fig. 1, and wherein bone graft 40 is illustrated in the either side of intervertebral disc 30, and has relative transverse process 70.Can detect and transmit about moving and the information of the load of vertebra 10,20 according to pick off 1 of the present invention, and in the implanted various spinal column key element.Described key element can comprise spinal column pedicle of vertebral arch 80, transverse process 70, articular surface etc.
How Fig. 1 and Fig. 2 can be used for not having spinal column measuring instrument and that close if having illustrated pick off 1 of the present invention.Pick off 1 started with variable number of times in the cycle after surgical operation.For example, around and close the unusual mobile of " piece " or excessively mobilely help to detect not combination.
Fig. 3 illustrated pick off 1 of the present invention how can be used to have measuring instrument spinal column and close.More particularly, pick off 1 is incorporated " skeleton " instrumentation 130 into, and described instrumentation 130 is down between lamina of vertebra 110 and the epipyramis plate 120.This pick off 1 detects and moves and load, and starts with transmission information in the cycle surgical operation after, thereby helps definite and whether close piece firm.
How Fig. 4 can be used for pedicle screw 130 if having illustrated pick off of the present invention.More particularly, pick off 1 incorporate in the pedicle screw 130 with help to detect and close in the piece any mobile unusually between the vertebra.
Fig. 5 has illustrated pick off 1 of the present invention and how can be used in the no vertebral implant (displacement product).More particularly, for example, artificial intervertebral disc displacement product 140 have the pick off 1 that is arranged on metal-bone interface.These pick off 1 test loads and move helping to replace intervertebral disc 140 at surgical operation, and after surgical operation, are determined the stable integraty of intervertebral disc-bone interface therebetween." normally " that internal sensor 2 detects between the intercalated disc inner boundaries of joint moves, move surgical operation after, to help definite intervertebral disc replacement product, and the rank that moves of optimization changing load and spinal column.
Fig. 6 has illustrated transducer arrangements device 150, and it is illustrated to having handle 151 and plunger 152.Handle 151 and plunger 152 allow for the insertion of pick off 3 of a part of A of the trocar 153.The trocar 153 can thrust cortex, and pick off 3 can be arranged.Fig. 7 has illustrated the insertion of pick off 3 in femur, and Fig. 8 has illustrated the insertion of pick off 3 in vertebra.Subsequently, pick off 3 can for example separate with integrated structure 154 by unscrewing screw operation or derotation operation.It is because they are modal be subjected to affect positions relevant with osteoporosis that these body parts are used as example, and is the wound relevant with osteoporosis.The size of pick off 3 can change between surpassing 1 centimetre at several millimeters.Pick off 3 can be implanted by percutaneous or implant in the operating mode of cutting.
Pick off 3 can be the part of the hardware that uses in hip and/or spinal column.Pick off 3 can be set to the various degree of depth, with permission cortex and bone trabecula is assessed.By arranging two pick offs 3, the distance between the pick off 3 can be determined by zone of paying close attention to and the power field that can produce.Energy field can be the standard energy source such as ultrasound wave, radio frequency and/or electromagnetic field.The deflection along with the time of energy waves for example will allow to detect the variation of desired parameters to be assessed.
Exemplary external monitoring sensor system according to Fig. 6 to Fig. 8 can read to contact bone mineral content and density every night.Sensing system also can transmit energy waves with vibration mode, described energy waves can simulation loading on bone, and cause bone mineral content and density to be improved.Pick off can also by or surpass implant and send energy waves to help the healing of fracture thus.
The fracture of hip and spinal vertebrae are that osteoporosis and outer damaging the spleen and stomach are common.Fig. 9 has illustrated screw 4 as internal sensor.Fractures 160 is crossed over by forcing screw 4, and pick off 4 is embedded in the screw 4.Pick off 4 in the screw 4 can send energy and pass fracture and read to obtain benchmark density, and along with the variation of time monitoring density, to confirm healing.Pick off 4 also can be sent energy waves to fractures by externally actuated, to help healing.Pick off 4 also can detect the variation of moving at fracture place, and the variation of moving between screw and the bone.This information helps the monitoring healing, and provides the health care supplier regulates weight loading according to indication ability.When union of fracture, can start now at the pick off in greater trochanter 4 shown in Figure 10 and Figure 11, to send energy waves to other two pick offs 4.Can assess bone density continuously like this.For example, when the patient was sleeping, pick off 4 can start by the pick off bed system.Energy source and receptor for example can be attached to below the bed.The information that is received can assessed in case of necessity every night, and is sent to the doctor by the standard electric measuring device.In process, can specific interval turn up the soil in the startup of night sensor and to read by various Drug therapy osteoporosis.
Outside that sends by pick off according to the present invention and internal energy ripple can be used in treatment fracture and spinal column and the process of closing in.
After deliberation the use of ultrasound wave, pulse electromagnetic field, combined magnetic field, Capacitance Coupled and DC current to the influence of the increasing property adjusting of somatomedin.Illustrated with pulse ultrasonic wave and excited " integrin " (it is the receptor on the cell surface), when exciting, produced intracellular signaling pathway.The protein that now description is related to inflammation, angiogenesis and bone healing.These protein comprise into bone morphogenetic protein (BMP)-7, alkali phosphatase, vascular endothelial cell growth factor (ECGF) and insulin-like growth factor (IGF)-1.The use of pulse electromagnetic field demonstrates the healing number of times that increases animal bone.Various waveforms influence bone in a different manner.
Utilize quantitative hyperacoustic sensing system can be used for external assessment calcaneus density.System according to the present invention is attached on patient's the bed, and by using the external ultrasonic of the form shown in Figure 10 and Figure 11, can assess bone density.Demonstrated and used energy field can stimulate the bone healing process.Can influence stimulation by externally measured, yet use the internal sensor system can change waveform, and produce the vibration signal of " loading " bone effectively.Can strengthen bone cortex and be used in effectively in the fracture and the treatment of osteoporosis, as shown in Figure 10 by this as can be known influence of multiple orthopedic rule.Pick off in Figure 10 is arranged in cortex or conduit.Energy waveform sends each other.Energy waveform can be excited by external system and receive, and perhaps is the part of pick off itself.Similarly, Figure 11 has illustrated vertebral levels, and pick off 4 sends energy waveform each other in vertebral levels, and is sent to outside receptor.This system/treatment can be used for handling fracture and osteoporosis.
Mainly illustrated hip and spinal column according to sensing system of the present invention, yet the present invention can be used for all skeletal sites of health.Figure 12 to Figure 18 has illustrated the various orientations according to pick off of the present invention, with treatment knee, hip and vertebra.
Figure 19 and Figure 20 have illustrated an exemplary embodiment of handle 170, and handle 170 removably is connected to implantable sensor body 5.In the present embodiment, handle has external screw thread, and it is screwed in the corresponding internal thread hole of body 5.
Pick off according to the present invention is used in the multiple orthopedic application, is included in joint implant aligning in the surgical operation.Operable pick off and watch-dog/system comprise any pick off known in the prior art, that for example describe and equipment/system in the Nexense patent.Computer-assisted surgery also is common.
At present, in femur and tibia, use pin to be attached to bone to allow pin arrays.This attached spatial orientation that helps knee/coxa joint in the process of operation.These arrays are by infrared optics identification or by electromagnetic equipment identification (referring to Figure 21 and Figure 22), information is re-entered in the software system of approval, allow the surgeon to observe the joint like this, simultaneously the implant of selecting is covered on the bone in three-dimensional mode.To produce many problems by using this pin:
Need thrust bone in the surgical site outside; Pain and drain after the pin position produces surgical operation;
It is loosening to go out cash sale in operating process, simultaneously modular array and infrared light;
Described pin requires the surgeon to change in operation process to work as prelocalization, and this is the comparison difficulty; And
The various metals and the instrument that use in surgical operation may influence electromagnetic field.
Insertion pin, locking array, record local joint required time of dissection have prolonged operation process significantly.And still need to touch independently a plurality of topographies that make it possible to observe knee with the permission computer on femur and the tibia.Be used for the time of information from sensor passes to receptor is also caused potential delay.Therefore, expectation can reduce or eliminate each in these problems.
The method according to this invention comprises pick off is implanted in the surgical site, utilizes described pick off in surgical procedures, and utilizes the pick off of being implanted to assess various desired parameters after surgical operation.
Figure 23 shows the pick off of imbedding 6 in femur and tibia, and Figure 24 shows the pick off 6 in the patella.Shown ligament comprises medial collateral ligament, lateral collateral ligament, anterior cruciate ligament and posterior cruciate ligament.Pick off 6 is implanted or implant in surgical procedures prior to percutaneous operation and/or joint arthroscopic diagnosis by cutting surgical operation.Figure 25 has illustrated ligament or tendon; Figure 26 has illustrated the pick off anchor clamps with pressurization and release lever; Figure 27 has illustrated the layout of pick off; And Figure 28 has shown the pick off of arranging in ligament.As shown in the step that illustrates at Figure 25 to Figure 28, pick off can be embedded in the ligament (Figure 25 shows exemplary ligament) by pick off anchor clamps (Figure 26) are provided, wherein said pick off anchor clamps are arranged on (Figure 27) around the ligament, and pick off is fixed on the ligament, as shown in Figure 28.Pick off also can be embedded in the bone, as subsequently as shown in Figure 33.The standard radiography techniques can be used in the guide arrangement angle and the degree of depth.
The outside non-radiation type that ultrasonic trocar system 180 allows pick off to put is visual, as shown in Figure 29.Sleeve pipe 181 holds emitter 182 and receptor 183.Subsequently, placement sensor 184 preferably is provided with to be used for insertion.Subsequently, the ultrasound wave arm can be used in the quick topography that obtains the articular surface and the degree of depth.The ultrasound wave insert is sent to energy waves in a plurality of a plurality of pick offs 7 of imbedding, and described pick off 7 reflects each other, and is back to ultrasonic transducer, as shown in Figure 17.Figure 17 has illustrated ultrasonic sensor 7, and it utilizes the reflection technology of sound wave.Acoustic reflection goes out the end of bone and the pick off of imbedding 7, is back to the receptor in the ultrasound wave insert.The sound wave of receptor detection of reflected and start sensor export computer screen to visual, as shown in Figure 18.
Ultrasound wave also sends penetrating beam to tibia.At this, emitter broadcasts ultrasound wave to isolating receptor 190.Femur/tibia deflection triggers the beam of receptor output.The additional capabilities that continuously ultrasonic beam is reflexed to the network of pick off 7 of imbedding pick off 7 allows accurate three-dimensional information.Pick off 7 is programmed to compensate irregular surface and variable surface temperature.The measurement of bone is based on the processing of the ultrasonic signal that is received.Speed of sound and ultrasonic velocity all provide measurement based on the speed speed of ultrasonic propagation by bone and soft tissue.These are measured feature and allow the formation of three-dimensional geometric shapes fast, and its information can be sent to computer system from the outside, and this will allow the integrated of prosthese, as shown in Figure 18.
In order to make sensing system obtain the information needed relevant with the space three-dimensional topography in joint, three pick offs of minimum need be implanted in each piece bone into the part of the one in joint.Can be by having single sleeve pipe (Figure 30) placement sensor of one or more pick offs (Figure 31), perhaps by a plurality of transducer arrangements sleeve pipe placement sensor (Figure 32).Pick off will have is with the graduated trocar, and the trocar will thrust skin, muscle, ligament, tendon, cartilage and bone.Figure 33 has illustrated the layout of pick off in opening the knee joint surgical operation, has wherein removed soft tissue, and cartilage and bone are cut.Handle 190 holds the plunger 191 of the degree of depth of controlling transducer arrangements.Referring to Figure 34 to Figure 37.Minimum-depth is determined with the cartilage of implanting prosthetic and implant and the quantity of bone by to be cut.For example, in skeleton and tibia, 10 millimeters to 15 millimeters of minimum cut.The degree of depth that pick off is arranged is corresponding with cutting, can not move in surgical procedures like this, and can be used in surgical operation in the cycle afterwards.Trocar needle point will hold the important document (Figure 34) of pick off, and when arriving the desired depth of arranging, pick off 8 is inserted into by discharging lockable mechanism (Figure 19), and lockable mechanism can for screw or rotate-separate lock connector, fracture member or any other and remove combining mechanism.
When sensing system is inserted into, the external energy ripple that uses can be ultrasound wave or electromagnetic wave.Thereby can avoid using the optical array method.The deflection of energy by the element of time of various media (cartilage and bone) and energy waves receives by pick off 8 and/or reflects back into outside receptor.By having multiple sensors 8, show threedimensional model.Make that like this surgeon can embedding pick off (Figure 33), use pick off (Figure 18, Figure 22) therebetween at surgical operation, and after surgical operation, make pick off implanted to utilize (Figure 12 and Figure 13).Correspondingly, the speed of information propagation will greatly increase with processed.
Figure 23 and Figure 24 have illustrated some key elements of knee joint soft tissue.In operating process, ACL, PCL, medial collateral ligament and lateral collateral ligament are extremely important to kneed balance.Pick off is embedded in the ligament of tendon by clamp mechanism (referring to Figure 25 to Figure 28).Information receives and handles by software system, and described software system is incorporated in the area of computer aided joint surgery equipment, and represents the visual simulation (Figure 22) in joint in the surgical procedures.Assess tough belt tension, pressure, shear etc.Soft tissue trim grid (balancing grid) helps the surgeon to realize that the soft tissue of being correlated with discharges and the parts rotation.
Figure 38 has illustrated the similar sensing system in the hip.Insert is similar to single-sensor insert shown in Figure 38, perhaps can be revised as shown in Figure 38.Insert is configured to the acetabular bone borer that sleeve pipe inserts, and it is used in the hip surgical operation of standard.Handle 200 makes construction of stable, and pick off 8 is arranged by the plunger of depressing in the handle 200.Figure 40 has illustrated mortar cup pick off insert.The hole that sleeve pipe inserts allows the layout of pick off 9.Described structure can be revised as the structure that is similar to Figure 29, comprising ultrasonic means, thereby help to make dissect visual.
Figure 34 to Figure 37 has illustrated the development of " intelligence " insert and " intelligence " instrument.The handle 210 of insert/instrument holds the pick off 8 of an array, with the insertion (Figure 35 and Figure 37) that helps accurately to cut bone (Figure 36) and prosthese and pick off.These pick offs 8 have carried out suitable preparation by ultrasound wave/electromagnetic wave transducer and the identification of receptor space to allow affirmation implant/bone interface, and confirm that implant is with proper depth and angle insertion.Can carry out the test of the stability of glued parts or interference fit parts subsequently.When surgical operation or be implanted in accurate insertion and the orientation that pick off on the prosthese also allows prosthese before the surgical operation.After surgical operation, also carry out and implant assessment.
Figure 39 has illustrated pick off 8 and has been inserted in the femur.Pick off 8 can from inside to outside be arranged, arrange from outside to inside, perhaps be incorporated into the far-end centralizer and/or the conduit limiter of prosthese.
Figure 41 has illustrated the side view of two spinal segments.The pick off insert is depicted as in the mode of percutaneous transducer arrangements is gone in the vertebral body.Figure 42 has illustrated the axial view of a vertebra preface.The pick off 9 implanted pedicles of vertebral arch of preparing detection of passing.
The sensing system of following the implantation of prosthese insertion illustrates in Figure 12, and Figure 12 is the front view of prosthese, and the pick off that shows knee joint, femur and tibial prosthesis, polyethylene implant and imbed.Figure 13 has illustrated has the kneed side view of implanting the prosthese that sensing system is arranged.Figure 14 has illustrated has the whole hip prosthesis of the sensing system of imbedding.Figure 15 has illustrated the side view of the pick off of imbedding in two sections of vertebra and implant.Top (axially) view of Figure 16 by prosthese/implant illustrated the sensing system in vertebral body.
Sensing system of the present invention can be used in before the surgical operation, interferes with the progress of tracking joint pathology and different treatments.Described system can be used in the surgical operation to help the implantation of prosthese/instrumentation/hardware.In spinal column, can assess neuronic influence, and the variation of vascular in surgical operation (especially correction surgical).Subsequently, these pick offs can be used in after the surgical operation, the variation that takes place along with the variation of time and dynamic variation with assessment.Pick off is activated in surgical operation, and the reading of stored parameter.And then after the surgical operation, pick off is activated and knows baseline.
Sensing system allows bone and the linked groups that is subjected to implantation person assessed, however be not limited to bone density, blood flow viscosity, temperature, strain, pressure, angular distortion, vibration, vascular/vein/lymphatic vessel flow, load, moment of torsion, distance, inclination, shape, elasticity, mobile and other.Because pick off is crossed over joint space, therefore can detect the variation of implant function.The example of implant function comprises that taking up wear, sinking, bone are integrated, conventional and mobile unusually, temperature, viscosity change, particulate matter, kinematics characteristic or the like.
Pick off can be by internal cell or outside measure power supply.The patient can assess by contactless actuating system in bed at night, and described contactless actuating system can be used radio frequency or electromagnetic/ultrasonic wave energy.The energy signal of sensing system can penetrate bed, start sensor, and be passed to the receptor that can be attached to equally on the bed.Pick off can be along with time " reinforcing " (for example, promoting by appropriate software), to assess various parameters.Pick off can be made amendment by external equipment, such as flash memory device.For example, one group of pick off of imbedding can be monitored detected spinal column and the progress of closing.When the parameter that provides was determined, identical pick off can be reprogrammed, to monitor adjacent spinal segments, and with the stress of forecast increase, and the subluxation of final adjacent vertebra preface.
Another feature of sensing system is in assessment therebetween, and sensing system can be by a series of sensor parameters circulations.This circulation example can be assessed bone density in bed the patient, and after this, the assessment vascular is in conjunction with stream viscosity and area supported.This assessment can have specified time interval or as required at random fixed time sequence take place.Information can by present telephone plant remote measurement be sent to the health care supplier.Similarly, the patient can assess in doctor's office by the external sensor actuator.Subsequently, the patient can assess a series of actions of the implant function parameter of stability etc. (comprise such as load, moment, move) by scrutiny by allowing the doctor.
Software system holds the sensor information that allows in the correlated grid in interval.Subsequently, doctor's assessment data and function wherein fall into outer highlighted of standard deviation, and these parameters are further assessed.
Although these sensing systems are mainly discussed to relevant with knee, hip and spinal column at this, yet these systems can be used for any skeletal system of health.
The use of described system is explained in the description of the present invention that is used for the muscle skeleton sensing system.Yet, should be noted that the present invention is not limited to this.Apparatus and method according to the invention can be used according to any needs.
Aforesaid description and accompanying drawing show principle of the present invention, preferred embodiment and operator scheme.Yet the present invention should not be understood that to be limited to above-mentioned specific embodiment.Those skilled in the art should will appreciate that other remodeling of the foregoing description.
Therefore, the foregoing description should be construed to be exemplary and not restrictive.Correspondingly, be to be understood that the remodeling of these embodiment can be implemented by those skilled in the art, and do not break away from the scope of the present invention that limits as subsequently claims.
Claims (3)
1. method that is used for the detection of biological location parameter may further comprise the steps:
On at least one vertebra of spinal column, carry out the bone implant procedure;
Provide at least one biometric sensor at described at least one vertebra place, described sensor measurement is selected from least one parameter in the group that comprises following parameter: the pressure in the environment adjacent, tension force, shear, relative position and vascular flow; And
At least one bioassay parameter by the described vertebra of described sensor measurement place.
2. according to the method for claim 1, described method further comprises:
The transfer of data that will be referred to described at least one bioassay parameter is to external source; And
Described data are analyzed to assess the bioassay situation of described at least one vertebra.
3. according to the method for claim 1, described method further is included on the transverse process of described vertebra one group of pick off is set.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201510178035.9A CN104887235B (en) | 2005-03-29 | 2006-03-29 | Body parameter detecting sensor and method for detecting body parameter |
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| Application Number | Priority Date | Filing Date | Title |
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| US66579705P | 2005-03-29 | 2005-03-29 | |
| US60/665,797 | 2005-03-29 | ||
| US60/763,761 | 2006-02-01 | ||
| US60/763,869 | 2006-02-01 |
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| CN201510178035.9A Division CN104887235B (en) | 2005-03-29 | 2006-03-29 | Body parameter detecting sensor and method for detecting body parameter |
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| CN101287408A true CN101287408A (en) | 2008-10-15 |
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| CNA2006800144919A Pending CN101287408A (en) | 2005-03-29 | 2006-03-29 | Body parameter detecting sensor and method for detecting body parameters |
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| ZA (1) | ZA200708433B (en) |
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102740771A (en) * | 2009-11-13 | 2012-10-17 | 皮埃尔和玛利居里大学(巴黎第六大学) | Device for measuring the activity of the spinal cord of a vertebra |
| CN103140168A (en) * | 2010-05-25 | 2013-06-05 | 药物代谢动力公司 | A method and apparatus for an implantable inertial-based sensing system for real-time, in vivo detection of spinal pseudarthrosis and adjacent segment motion |
| CN103458830A (en) * | 2011-03-07 | 2013-12-18 | 莱普医疗公司 | Device for monitoring a medical prosthesis and the human body |
| CN105451690A (en) * | 2013-06-23 | 2016-03-30 | 威廉·L·亨特 | Devices, systems and methods for monitoring knee replacements |
| CN108135638A (en) * | 2015-09-30 | 2018-06-08 | 皇家飞利浦有限公司 | For being implanted into the system of bone tissue |
| CN110882094A (en) * | 2013-03-15 | 2020-03-17 | 威廉·L·亨特 | Devices, systems, and methods for monitoring hip replacements |
| CN113423324A (en) * | 2018-10-05 | 2021-09-21 | 奥索传感器公司 | Measurement system configured to support installation of a ball and socket joint and method thereof |
| EP4104895A1 (en) | 2021-06-14 | 2022-12-21 | Instituto Politécnico De Leiria | Intelligent biomimetic biodevice and use thereof |
| CN116236266A (en) * | 2023-02-09 | 2023-06-09 | 上海康定医疗器械有限公司 | Remote automatic six-shaft collar type bracket system and bone orthopedic treatment device |
| US11779273B2 (en) | 2016-03-23 | 2023-10-10 | Canary Medical Inc. | Implantable reporting processor for an alert implant |
| US11786126B2 (en) | 2014-09-17 | 2023-10-17 | Canary Medical Inc. | Devices, systems and methods for using and monitoring medical devices |
| CN117643496A (en) * | 2024-01-30 | 2024-03-05 | 中国人民解放军西部战区总医院 | Thoracolumbar spine individual nail placement device and use method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102740771A (en) * | 2009-11-13 | 2012-10-17 | 皮埃尔和玛利居里大学(巴黎第六大学) | Device for measuring the activity of the spinal cord of a vertebra |
| CN103140168A (en) * | 2010-05-25 | 2013-06-05 | 药物代谢动力公司 | A method and apparatus for an implantable inertial-based sensing system for real-time, in vivo detection of spinal pseudarthrosis and adjacent segment motion |
| CN103458830A (en) * | 2011-03-07 | 2013-12-18 | 莱普医疗公司 | Device for monitoring a medical prosthesis and the human body |
| CN103458830B (en) * | 2011-03-07 | 2016-08-10 | 莱普医疗公司 | For monitoring the equipment of medical prosthetic and human body |
| CN110882094A (en) * | 2013-03-15 | 2020-03-17 | 威廉·L·亨特 | Devices, systems, and methods for monitoring hip replacements |
| CN113274173A (en) * | 2013-06-23 | 2021-08-20 | 卡纳里医疗公司 | Devices, systems, and methods for monitoring knee replacements |
| CN110731838A (en) * | 2013-06-23 | 2020-01-31 | 威廉·L·亨特 | Devices, systems, and methods for monitoring knee replacements |
| CN105451690A (en) * | 2013-06-23 | 2016-03-30 | 威廉·L·亨特 | Devices, systems and methods for monitoring knee replacements |
| US11786126B2 (en) | 2014-09-17 | 2023-10-17 | Canary Medical Inc. | Devices, systems and methods for using and monitoring medical devices |
| CN108135638A (en) * | 2015-09-30 | 2018-06-08 | 皇家飞利浦有限公司 | For being implanted into the system of bone tissue |
| US11779273B2 (en) | 2016-03-23 | 2023-10-10 | Canary Medical Inc. | Implantable reporting processor for an alert implant |
| US11896391B2 (en) | 2016-03-23 | 2024-02-13 | Canary Medical Inc. | Implantable reporting processor for an alert implant |
| CN113423324A (en) * | 2018-10-05 | 2021-09-21 | 奥索传感器公司 | Measurement system configured to support installation of a ball and socket joint and method thereof |
| EP4104895A1 (en) | 2021-06-14 | 2022-12-21 | Instituto Politécnico De Leiria | Intelligent biomimetic biodevice and use thereof |
| CN116236266A (en) * | 2023-02-09 | 2023-06-09 | 上海康定医疗器械有限公司 | Remote automatic six-shaft collar type bracket system and bone orthopedic treatment device |
| CN116236266B (en) * | 2023-02-09 | 2023-08-18 | 上海康定医疗器械有限公司 | Remote automatic six-shaft collar type bracket system and bone orthopedic treatment device |
| CN117643496A (en) * | 2024-01-30 | 2024-03-05 | 中国人民解放军西部战区总医院 | Thoracolumbar spine individual nail placement device and use method thereof |
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