CN115227464A - Pressure measuring device, preparation method and pressure measuring equipment - Google Patents

Pressure measuring device, preparation method and pressure measuring equipment Download PDF

Info

Publication number
CN115227464A
CN115227464A CN202210933757.0A CN202210933757A CN115227464A CN 115227464 A CN115227464 A CN 115227464A CN 202210933757 A CN202210933757 A CN 202210933757A CN 115227464 A CN115227464 A CN 115227464A
Authority
CN
China
Prior art keywords
base body
sensing units
pressure
piezoelectric material
base
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202210933757.0A
Other languages
Chinese (zh)
Inventor
李舟
孟建平
吴礼
石波璟
张纪锋
蔚鑫
秦峰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beijing Ansong Technology Co ltd
Original Assignee
Beijing Ansong Technology Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Beijing Ansong Technology Co ltd filed Critical Beijing Ansong Technology Co ltd
Priority to CN202210933757.0A priority Critical patent/CN115227464A/en
Publication of CN115227464A publication Critical patent/CN115227464A/en
Pending legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4657—Measuring instruments used for implanting artificial joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3877—Patellae or trochleae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4657—Measuring instruments used for implanting artificial joints
    • A61F2002/4666—Measuring instruments used for implanting artificial joints for measuring force, pressure or mechanical tension

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to the technical field of medical equipment applied to an artificial knee joint replacement operation, and discloses a pressure measuring device, a preparation method and pressure measuring equipment, wherein the pressure measuring device is used for measuring pressure between artificial knee joint prostheses and comprises a base body, a plurality of sensing units arranged on the surface of the base body and a packaging layer covering the sensing units, the base body is arranged between a femur component and a tibia component, the sensing units are arranged on one surface of the base body facing the femur component and can at least cover the areas of the surface of the base body, which are in contact with the two condyles of the femur component, each sensing unit comprises a bottom electrode layer, a piezoelectric material layer and a top electrode layer, the bottom electrode layers, the piezoelectric material layers and the top electrode layers are arranged in the direction away from the base body, and the sensing units are configured to convert the pressure applied to the surface of the base body by the femur component into electric signals and transmit the electric signals to an external signal processing device for analysis and processing so as to determine pressure information on the surface of the base body.

Description

Pressure measuring device, preparation method and pressure measuring equipment
Technical Field
The invention relates to the technical field of medical equipment applied to artificial knee joint replacement surgery, in particular to a pressure measuring device, a preparation method and pressure measuring equipment.
Background
With the increasing aging of population, the number of patients with knee joint diseases is on the rise in recent years, the knee joint diseases can cause discomfort such as knee joint pain, swelling, reduced range of motion and the like, the daily life of the patients is seriously affected, and the artificial knee joint replacement surgery is an effective method for treating the knee joint diseases at present, can relieve the pain of the patients and improve the life quality of the patients.
When carrying out artifical knee joint replacement, will set up the shin bone gasket between knee joint prosthesis's shin bone part and thighbone part, the upper surface of shin bone gasket and the interior condyle of thighbone part and the atress between the outer condyle often are unbalanced, and at the operation in-process, the doctor often carries out the adjustment of atress balance through the elasticity degree of adjustment knee joint both sides ligament to atress has the rationality after making artifical knee joint implant human body, improves the quality of life of patient postoperative.
Among the prior art, the doctor can't the accurate atress condition that obtains between the knee joint prosthesis, and the doctor stretches into the knee joint intracavity both sides with the finger usually, relies on the experience to adjust the elasticity degree of ligament, and this brings certain risk and unstable factor for artifical knee joint replacement operation, in case adjust improperly, will influence the recovery of patient's postoperative.
Disclosure of Invention
The invention provides a pressure measuring device, a preparation method and pressure measuring equipment, which are used for solving the problems that the stress condition among knee joint prostheses cannot be accurately acquired in an artificial knee joint replacement operation in the prior art, and further, the ligament adjustment cannot be guaranteed.
In a first aspect, an embodiment of the present invention provides a pressure measurement apparatus for measuring pressure between artificial knee joint prostheses, including a base, a plurality of sensing units disposed on a surface of the base, and a package layer covering the sensing units, wherein the base is disposed between a femoral component and a tibial component, the plurality of sensing units are disposed on a surface of the base facing the femoral component, and at least a region where the surface of the base contacts with both condyles of the femoral component can be covered by the plurality of sensing units, the sensing units include a bottom electrode layer, a piezoelectric material layer, and a top electrode layer disposed in a direction away from the base, and the sensing units are configured to convert pressure applied to the surface of the base by the femoral component into electrical signals and transmit the electrical signals to an external signal processing apparatus for analysis processing so as to determine pressure information on the surface of the base.
In the embodiment, the sensing unit is integrated on the base body, when the sensing unit is subjected to pressure applied by the femoral component, the electric signal can be output by utilizing a piezoelectric effect, and the electric signal is converted into pressure information after being analyzed and processed by the signal processing device, so that a doctor can adjust the tightness of the knee ligament according to the obtained pressure information, the stress of the tibial gasket is balanced, the local friction is avoided, and the postoperative rehabilitation of a patient is ensured; in addition, the sensing unit does not need to be driven by a power supply during working, has the characteristics of small size and thin thickness, can acquire the pressure information of the irregular and uneven curved surfaces of the double condyles of the femoral component, and can adapt to the special service environment of the knee joint.
Optionally, a plurality of the sensing units are distributed on the surface of the substrate in an array.
In the above embodiment, the sensing units are distributed on the surface of the substrate in an array manner, so that the density of the sensing units on the surface of the substrate is increased, and the sensitivity is improved.
Optionally, the plurality of sensing units includes a first group of sensing units and a second group of sensing units, the first group of sensing units is disposed on a first area of the base surface, the second group of sensing units is disposed on a second area of the base surface, the first area corresponds to the medial condyle of the femoral component, the second area corresponds to the lateral condyle of the femoral component, and a transition area is disposed between the first area and the second area.
Optionally, the encapsulation layer covers at least a top surface of the sensing unit facing away from the base and a side surface of the sensing unit.
In the above embodiment, the top surface and the side surface of the sensing unit are both provided with exposed electrode materials, and the encapsulation layer at least covers the top surface and the side surface of the sensing unit, so that the effect of insulation protection can be achieved, and the influence of moisture inside the knee joint can be avoided.
Optionally, the encapsulation layers of the sensing units are connected to form an integrated structure.
Optionally, the piezoelectric material layer is a thin film structure formed by one or a mixture of an inorganic piezoelectric material and an organic piezoelectric material.
Optionally, the piezoelectric material layer is a thin film structure formed by sputtering an inorganic piezoelectric material, or the piezoelectric material layer is a thin film structure formed by electrostatic spinning an organic piezoelectric material.
Optionally, the base is a thin film structure configured to be adhered to a tibial pad in an artificial knee prosthesis.
Among the above-mentioned embodiment, the base member is the film structure, in the operation process, can paste the base member to the shin bone gasket among the artifical knee joint prosthesis, and communicate the signal transmission passageway between sensing unit and the signal processing device, thereby can measure the pressure information that the both condyles of thighbone part applied to the shin bone gasket, and adjust the elasticity degree of knee joint both sides ligament according to the pressure information who records, adjust the completion back, peel off the base member from the shin bone gasket can, high durability and convenient use, and, the base member can adapt to the shin bone gasket that different manufacturers produced, has stronger adaptability.
Optionally, the sum of the thicknesses of the substrate and the sensing unit is not more than 1.0mm.
In the above embodiment, the total thickness of the base body and the sensing unit may be 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, etc., and during the operation, when the tightness of ligaments on two sides of the knee joint is adjusted according to the measured pressure information, the base body may be peeled off from the tibial insert, and since the total thickness of the base body and the sensing unit is thin, the cooperation between the femoral component and the tibial insert is not affected after peeling.
Optionally, the pressure measurement device further comprises a protective film, and the protective film is peelably arranged on the surfaces of the substrate and the packaging layer.
In the above embodiment, the protective film can protect the surface of the substrate and the surface of the package layer during transportation and storage of the pressure measurement device, so as to prevent impurities such as dust in the air from adhering to the surfaces and causing pollution.
Optionally, the base is the same shape and size as a tibial insert in an artificial knee prosthesis.
In the above embodiment, the sensing unit is integrated on the base body having the same shape and size as the tibial gasket, and in the process of adjusting the ligaments on the two sides of the knee joint, the base body is temporarily placed at the position of the tibial gasket, so that the pressure information applied to the surface of the base body by the femoral component is acquired through the sensing unit, data support is improved for adjustment of the ligaments, and after adjustment is completed, the base body is taken out, and then the tibial gasket is installed between the femoral component and the tibial component.
In a second aspect, an embodiment of the present invention further provides a method for manufacturing a pressure measurement device according to any one of the above technical solutions, where the method includes:
preparing a base body, and shielding partial area of the surface of the base body through a shielding object to form a shielding area and a plurality of exposed areas on the surface of the base body;
sequentially preparing a bottom electrode layer, a piezoelectric material layer and a top electrode layer in the exposed area;
and preparing an encapsulation layer on the surface of the top electrode layer.
In the embodiment, under the condition that the shielding object shields part of the surface of the base body, the sensing units can be formed in other exposed areas, so that the sensing units are distributed at different positions of the base body and are spaced from each other, the sensing units can be free from the influence of internal stress, meanwhile, the sensing units do not need to be driven by a power supply during working, have the characteristics of small size and thin thickness, can acquire the pressure information of the irregular and uneven curved surfaces of the double condyles of the femoral component, and can adapt to the special service environment of the knee joint.
Optionally, the shielding a partial area of the surface of the base body by the shielding object to form a shielded area and a plurality of exposed areas on the surface of the base body specifically includes:
and attaching adhesive tapes which are arranged in a crossed manner to the surface of the base body, wherein the parts covered by the adhesive tapes form the shielding areas, and the parts uncovered by the adhesive tapes form the exposed areas.
In a third aspect, an embodiment of the present invention further provides a pressure measurement apparatus, including the pressure measurement device in any one of the above technical solutions, further including a signal processing device and a display device, where the signal processing device is connected to the sensing unit and configured to determine pressure information of the substrate surface according to an electrical signal output by the sensing unit;
and the display device is connected with the signal processing device and is used for displaying the pressure information of the surface of the substrate.
In the above embodiment, when the sensing units distributed on the surface of the base body are subjected to the pressure applied by the femoral component, the piezoelectric effect can be utilized to output the electric signals, and the signal processing device can transmit the pressure information of the surface of the base body to the display device after determining the pressure information of the surface of the base body according to the electric signals output by the sensing units, so that the pressure information of the surface of the base body is displayed on the screen in real time through the display device, thereby facilitating the checking of a doctor and assisting the doctor in ligament adjustment.
Drawings
FIG. 1 is a schematic view of a pressure measurement device according to an embodiment of the present invention in position within a knee joint during use;
FIG. 2 is a schematic diagram illustrating the distribution of sensing units on the surface of a substrate in a pressure measurement device according to an embodiment of the present invention;
FIG. 3 is a partial cross-sectional view of a pressure measurement device provided in accordance with an embodiment of the present invention;
FIG. 4 is a partial cross-sectional view of another pressure measurement device provided in accordance with an embodiment of the present invention;
FIG. 5 is a flow chart illustrating the preparation of a pressure measurement device according to an embodiment of the present invention;
fig. 6 is a schematic composition diagram of a pressure measurement device according to an embodiment of the present invention.
Reference numerals:
10-a pressure measuring device; 11-a substrate; 111-a first region; 112-a second region; 113-a third region; 12-a sensing unit; 12 a-a first set of sensing units; 12 b-a second set of sensing units; 121-a bottom electrode layer; 122-a layer of piezoelectric material; 123-a top electrode layer; 13-an encapsulation layer; 14-a protective film; 20-femoral component; 201-medial condyle; 202-lateral condyle; 30-a tibial component; 40-signal processing means; 50-display device.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to the accompanying drawings, and it is apparent that the described embodiments are only a part of the embodiments of the present invention, not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The embodiment of the invention provides a pressure measuring device, which is used for solving the problems that the stress condition among knee joint prostheses can not be accurately acquired in an artificial knee joint replacement operation in the prior art, and further, the ligament adjustment can not be guaranteed.
As shown in fig. 1, 2, 3 and 4, the pressure measuring device 10 is used for measuring pressure between artificial knee joint prostheses, and includes a base 11, a plurality of sensing units 12 disposed on a surface of the base 11, and a packaging layer 13 covering the sensing units 12, the base 11 is disposed between a femoral component 20 and a tibial component 30, the sensing units 12 are disposed on a surface of the base 11 facing the femoral component 20 and can cover at least a region where the surface of the base 11 contacts with both condyles of the femoral component 20, the sensing units 12 include a bottom electrode layer 121, a piezoelectric material layer 122 and a top electrode layer 123 disposed in a direction away from the base 11, and the sensing units 12 are configured to convert pressure applied to the surface of the base 11 by the femoral component 20 into electrical signals and transmit the electrical signals to an external signal processing device for analysis processing so as to determine pressure information on the surface of the base 11.
Specifically, in the pressure measurement device 10, a plurality of sensing units 12 are disposed on the surface of the base 11, the sensing units 12 can cover at least the area where the surface of the base 11 contacts with the two condyles of the femoral component 20, the sensing units 12 include piezoelectric materials, the piezoelectric materials have piezoelectric effects, that is, when the crystal is subjected to an external force in a certain fixed direction, an electric polarization phenomenon is generated inside the crystal, and electric charges with opposite signs are generated on two surfaces, when the external force is removed, the crystal returns to an uncharged state, and the amount of electric charge generated by the stress of the crystal is proportional to the magnitude of the external force, that is, when the sensing units 12 are subjected to the pressure applied by the femoral component 20, an electric signal can be output by using the piezoelectric effects of the piezoelectric materials, the stronger the electric signal indicates that the applied pressure is greater, and conversely, the weaker electric signal indicates that the applied pressure is smaller, the electric signal can be converted into pressure information after being analyzed and processed by the signal processing device, the pressure information includes the magnitude of the pressure and the distribution of the pressure, that a doctor can determine which part of the tibial gasket is subjected to the pressure, and thus, the tightness of the tibial gasket can be adjusted, and the knee joint can be ensured after the friction of the patient is recovered.
The sensing units 12 are distributed at different positions of the base body 11, and are spaced from each other, and are not affected by internal stress, the sensing units 12 specifically include a bottom electrode layer 121, a piezoelectric material layer 122 and a top electrode layer 123, because the piezoelectric material has a piezoelectric effect, the sensing units 12 do not need to be driven by a power supply when working, and the bottom electrode layer 121, the piezoelectric material layer 122 and the top electrode layer 123 are all ultrathin layers, so that the sensing units 12 have the characteristics of small size and thin thickness, and can acquire pressure information of double-condyle irregular and uneven curved surfaces of the femoral component 20, thereby adapting to special service environments of the knee joint.
Alternatively, the electrode material used for the bottom electrode layer 121 and the top electrode layer 123 may be any one of copper (Cu), silver (Ag), gold (Au), platinum (Pt), and palladium (Pd), and the electrode material is required to have low resistance and no ferromagnetism, and may be specifically deposited on the surface of the substrate 11 by sputtering or evaporation.
The piezoelectric material layer 122 may be an inorganic piezoelectric material or an organic piezoelectric material, or a mixture thereof, where the inorganic piezoelectric material has a high piezoelectric coefficient, and the inorganic piezoelectric material may be zinc oxide (ZnO) or barium titanate (BaTiO) 3 ) Lead zirconate titanate (Pb (Zr, ti) O) 3 ) Gallium nitride (GaN), zinc stannate (ZnSnO) 3 ) Sodium niobate (NaNbO) 3 ) Potassium niobate (KNbO) 3 ) Lithium niobate (KNbO) 3 ) Bismuth ferrite (BiFeO) 3 ) And, the inorganic piezoelectric material may be formed on the surface of the bottom electrode layer 121, specifically, via a sputtering process.
The organic piezoelectric material can withstand large deformation and has flexibility, and may be any one of polyvinylidene fluoride (PVDF) and PVDF-TrFE and P (VDF/TFE) derivatives of PVDF, and may be specifically formed on the surface of the bottom electrode layer 121 by an electrospinning process.
After the piezoelectric material is prepared, high-voltage polarization is carried out, and the piezoelectric coefficient and the piezoelectric property of the piezoelectric material are enhanced.
The surface of the sensing unit 12 is further provided with an encapsulation layer 13, and the encapsulation layer 13 may specifically be a Parylene (Parylene) coating, as shown in fig. 3 and 4, the encapsulation layer 13 covers at least the top surface of the sensing unit 12 away from the base 11 and the side surface of the sensing unit 12, because both the top surface and the side surface of the sensing unit 12 have exposed electrode materials, and the encapsulation layer 13 covers at least the top surface and the side surface of the sensing unit 12, which may play a role of insulation protection, and may also avoid being affected by moisture inside the knee joint.
Each sensing unit 12 may have an independent encapsulation layer 13, or the encapsulation layers 13 of a plurality of sensing units 12 may be connected to form an integral structure, for which the manufacturing process may be simplified and the flatness of the surface of the substrate 11 may be improved.
The sensing units 12 can cover at least the area where the surface of the base 11 contacts the femoral component 20, and the sensing units 12 may be randomly arranged on the surface of the base 11, or may be arranged according to a certain rule, for example, one sensing unit 12 may be used as a center and radially dispersed around the sensing unit 12, or, as shown in fig. 2, may be distributed on the surface of the base 11 in an array manner, specifically, a plurality of sensing units 12 form a plurality of rows and a plurality of columns on the surface of the base 11, so that the density of the sensing units 12 on the surface of the base 11 is increased, and the sensitivity is improved.
With continued reference to fig. 2, the plurality of sensing elements 12 includes a first set of sensing elements 12a and a second set of sensing elements 12b, the first set of sensing elements 12a is disposed in a first region 111 of the surface of the base 11, the second set of sensing elements 12b is disposed in a second region 112 of the surface of the base 11, the first region 111 corresponds to the medial condyle 201 of the femoral component 20, the second region 112 corresponds to the lateral condyle 202 of the femoral component 20, and a transition region 113 is disposed between the first region 111 and the second region 112.
The first group of sensing units 12a may be distributed in an array or other form in the first area 111, and similarly, the second group of sensing units 12b may be distributed in an array or other form in the second area 112, and during the operation, it may be determined whether the forces on the two condyles of the femoral component 20 are balanced according to the pressure information collected by the first group of sensing units 12a and the second group of sensing units 12 b.
The transition area 113 is interposed between the first area 111 and the second area 112, the transition area 113 is not provided with the sensing unit 12, and when the base 11 is a thin film structure, the transition area 113 may be folded to a certain degree when the base 11 is adhered to a tibial insert surface in an artificial knee prosthesis, so that the first area 111 corresponds to the medial condyle 201 of the femoral component 20, and the second area 112 corresponds to the lateral condyle 202 of the femoral component 20.
In some embodiments, the base 11 is a thin film structure, and the base 11 is configured to be affixed to a tibial insert surface in an artificial knee prosthesis.
In the operation process, can paste the base member 11 to the shin bone gasket among the artificial knee joint prosthesis, and communicate the signal transmission passageway between sensing unit 12 and the signal processing device, thereby can measure the pressure information that the both condyles of thighbone part 20 applied to the shin bone gasket, and adjust the elasticity degree of knee joint both sides ligament according to the pressure information who records, adjust the completion back, with the base member 11 peel off from the shin bone gasket can, high durability and safety, can not produce cross contamination, and, base member 11 is the film structure, has the flexibility, thereby can be applicable to the shin bone gasket of the structure difference that different merchants produced, strong adaptability has.
The surface of the tibial insert facing the femoral component may not be planar, the portion corresponding to the area between the condyles of the femoral component being higher, and the transition area 113 in the middle of the base 11 may accommodate the configuration of such a tibial insert.
In addition, the overall thickness of the base body 11 and the sensing unit 12 is thin, so that the matching between the femoral component 20 and the tibial insert is not affected after the tightness of ligaments on two sides of the knee joint is adjusted and the base body 11 is peeled off from the surface of the tibial insert.
Optionally, the sum of the thicknesses of the sensing units 12 is not more than 1.0mm, and may be, for example, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, or the like.
As shown in fig. 4, the pressure measurement device 10 further includes a protective film 14, and the protective film 14 is releasably disposed on the surfaces of the substrate 11 and the encapsulation layer 13. The protective film 14 can protect the surfaces of the substrate 11 and the encapsulation layer 13 during the transportation and storage of the pressure measurement device 10, so as to prevent impurities such as dust in the air from adhering to the surfaces and causing pollution.
In other embodiments, the base 11 has the same shape and size as the tibial insert of the artificial knee prosthesis, and the sensing unit 12 is integrated on the base 11 having the same shape and size as the tibial insert, and during the adjustment of the ligaments on both sides of the knee joint, the base 11 is temporarily placed between the femoral component 20 and the tibial component 30, that is, the position of the tibial insert, so as to collect information on the pressure applied to the surface of the base 11 by the femoral component 20 through the sensing unit 12, thereby improving data support for the adjustment of the ligaments, and after the adjustment is completed, the base 11 is removed, and the tibial insert is mounted between the femoral component 20 and the tibial component 30. Because the base body 11 and the tibial insert in the artificial knee joint prosthesis have the same shape and size, and the sensing unit 12 is also of an ultrathin structure, the stress condition of the base body 11 is the same as that of the tibial insert.
After the sensing unit 12 is integrated on the surface of the substrate 11, the position of the sensing unit 12 on the surface of the substrate 11 is relatively fixed, so that the pressure distribution condition of the surface of the substrate 11 can be accurately obtained according to the position information of the sensing unit 12 and the acquired pressure information.
In addition, the base 11 may have a hollow structure, and the space inside the base 11 may be used to arrange a wire harness or the like so as to transmit the electrical signal generated by the sensing unit 12 to the external signal processing device 40.
Based on the same inventive concept, as shown in fig. 5, an embodiment of the present invention further provides a method for manufacturing a pressure measurement device 10 according to any one of the above technical solutions, where the method includes:
step S101: preparing a base body 11, wherein the base body 11 can be of a thin film structure and also can be of a three-dimensional structure with the same shape and size as the tibial gasket;
step S102: shielding part of the surface of the base body 11 by a shielding object to form a shielding area and a plurality of exposed areas on the surface of the base body 11;
step S103: preparing a bottom electrode layer 121, a piezoelectric material layer 122 and a top electrode layer 123 in sequence in the exposed area;
step S104: and preparing an encapsulation layer 13 on the surface of the top electrode layer 123.
Optionally, in step S102, the step of shielding a partial area of the surface of the base 11 by a shielding object to form a shielded area and a plurality of exposed areas on the surface of the base 11 specifically includes:
the adhesive tapes are attached to the surface of the base 11 so as to intersect with each other, and the portion covered with the adhesive tapes forms a masking region while the portion not covered with the adhesive tapes forms a bare region.
That is, an adhesive tape may be used as a shielding object, a criss-cross mesh structure is formed on the surface of the base 11, so as to form a plurality of exposed areas, and the exposed areas are arranged in an array, so that the sensing unit 12 having the bottom electrode layer 121, the voltage material layer, and the top electrode layer 123 may be formed in the exposed areas, and after the shielding object is removed, the encapsulation layer 13 is formed on the surface of the base 11, so that the encapsulation layer 13 covers the top surface and the side surface of the sensing unit 12.
Optionally, the adhesive tape is made of polyimide.
In the manufacturing process, other process steps are also included, for example, polarization treatment is performed on the piezoelectric material, and when the bottom electrode layer 121 and the top electrode layer 123 are manufactured, wires for transmitting electrical signals are provided, and the like, which will not be described in detail herein.
The following examples will now be used to illustrate the fabrication of the pressure measurement device 10, including:
dividing the substrate by polyimide tapes according to the number and size of the sensing units 12 to shield the parts not subjected to deposition, for example, dividing the surface of the substrate 11 into a square array with a side length of 1cm by using polyimide tapes with a width of 5mm in a horizontal and vertical staggered manner;
depositing a gold (Au) target material by adopting a direct current magnetron sputtering mode to prepare a bottom electrode layer 121, wherein the power is 100-150W, the time is 10-15min, and the thickness of the prepared bottom electrode layer 121 is 100-200nm;
preparing a piezoelectric material layer 122 by adopting a sputtering and magnetron sputtering barium titanate (BaTiO 3) target material, wherein the power is 50-100W, the time is 10-30min, and the thickness of the prepared piezoelectric material layer 122 is 100-200nm;
depositing a gold (Au) target on the surface of the piezoelectric material layer 122 by adopting a direct-current magnetron sputtering mode to prepare a top electrode layer 123; the power is 100-150W, the time is 10-15min, and the thickness of the prepared top electrode layer 123 is 100-200nm;
removing the polyimide adhesive tape, and packaging the surface of the substrate 11 by adopting parylene;
and carrying out polarization treatment on the piezoelectric material layer 122, wherein the intensity of the polarization electric field is 1kV/cm-10kV/cm, and the time is 15-30min.
And finally, communicating the sensing unit 12 with the outside to carry out performance test.
Based on the same technical concept, the embodiment of the present invention further provides a pressure measurement apparatus, as shown in fig. 6, the pressure measurement apparatus includes the pressure measurement device 10 in any one of the above technical solutions, further includes a signal processing device 40 and a display device 50, the signal processing device 40 is connected to the sensing unit 12, and is configured to determine pressure information of the surface of the substrate 11 according to the electrical signal output by the sensing unit 12; the display device 50 is connected to the signal processing device 40 and is used for displaying the pressure information on the surface of the substrate 11.
When the sensing units 12 distributed on the surface of the base 11 are subjected to the pressure applied by the femoral component 20, an electric signal can be output by using the piezoelectric effect, and after the signal processing device 40 determines the pressure information on the surface of the base 11 according to the electric signal output by the sensing units 12, the pressure information can be transmitted to the display device 50, so that the pressure information on the surface of the base 11 can be displayed on a screen through the display device 50 in real time, and therefore, the pressure information is convenient for a doctor to view and assists the doctor in ligament adjustment.
It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims (14)

1. A pressure measuring device is used for measuring pressure between artificial knee joint prostheses and comprises a base body, a plurality of sensing units and a packaging layer, wherein the sensing units are arranged on the surface of the base body, the base body is arranged between a femoral component and a tibial component, the sensing units are arranged on one surface of the base body facing the femoral component, the sensing units can at least cover the area where the surface of the base body is contacted with the two condyles of the femoral component, the sensing units comprise a bottom electrode layer, a piezoelectric material layer and a top electrode layer which are arranged in the direction away from the base body, and the sensing units are configured to convert the pressure applied to the surface of the base body by the femoral component into electric signals and transmit the electric signals to an external signal processing device for analysis and processing so as to determine pressure information of the surface of the base body.
2. The pressure measurement device of claim 1, wherein a plurality of the sensing units are distributed in an array on the substrate surface.
3. The pressure measurement device of claim 1 or 2, wherein the plurality of sensing units includes a first set of sensing units disposed on a first region of the base surface and a second set of sensing units disposed on a second region of the base surface, the first region corresponding to a medial condyle of the femoral component, the second region corresponding to a lateral condyle of the femoral component, and a transition region disposed between the first region and the second region.
4. Pressure measuring device according to claim 1 or 2, characterized in that the encapsulation layer covers at least a top side of the sensing unit facing away from the base body and a side of the sensing unit.
5. The pressure measurement device of claim 4, wherein the encapsulation layers of a plurality of the sensing cells are connected to form a unitary structure.
6. The pressure measurement device according to claim 1 or 2, wherein the piezoelectric material layer is a thin film structure formed of a mixture of one or both of an inorganic piezoelectric material and an organic piezoelectric material.
7. The pressure measurement device according to claim 6, wherein the piezoelectric material layer is a thin film structure formed by a sputtering process of an inorganic piezoelectric material, or the piezoelectric material layer is a thin film structure formed by an electrospinning process of an organic piezoelectric material.
8. Pressure measuring device according to claim 1 or 2, wherein the base body is of a thin-film construction, the base body being configured for gluing to a tibial pad in an artificial knee prosthesis.
9. The pressure measurement device of claim 8, wherein the sum of the thicknesses of the substrate and the sensing unit is no greater than 1.0mm.
10. The pressure measurement device according to claim 1 or 2, further comprising a protective film that is peelably provided to surfaces of the base and the encapsulation layer.
11. The pressure measurement device of claim 1 or 2, wherein the base is the same shape and size as a tibial insert in an artificial knee prosthesis.
12. A method of manufacturing a pressure measurement device according to any one of claims 1 to 11, comprising:
preparing a base body, and shielding partial area of the surface of the base body through a shielding object to form a shielding area and a plurality of exposed areas on the surface of the base body;
sequentially preparing a bottom electrode layer, a piezoelectric material layer and a top electrode layer in the exposed area;
and preparing an encapsulation layer on the surface of the top electrode layer.
13. The method according to claim 12, wherein the step of forming the masked area and the exposed areas on the surface of the base body by masking a portion of the surface of the base body with a mask comprises:
and attaching adhesive tapes which are arranged in a crossed manner to the surface of the base body, wherein the shielding area is formed by the part covered by the adhesive tapes, and the exposed area is formed by the part uncovered by the adhesive tapes.
14. A pressure measuring apparatus, comprising the pressure measuring device according to any one of claims 1 to 11, and further comprising a signal processing device and a display device, wherein the signal processing device is connected to the sensing unit and configured to determine pressure information of the substrate surface according to the electrical signal output by the sensing unit;
and the display device is connected with the signal processing device and is used for displaying the pressure information of the surface of the substrate.
CN202210933757.0A 2022-08-04 2022-08-04 Pressure measuring device, preparation method and pressure measuring equipment Pending CN115227464A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202210933757.0A CN115227464A (en) 2022-08-04 2022-08-04 Pressure measuring device, preparation method and pressure measuring equipment

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202210933757.0A CN115227464A (en) 2022-08-04 2022-08-04 Pressure measuring device, preparation method and pressure measuring equipment

Publications (1)

Publication Number Publication Date
CN115227464A true CN115227464A (en) 2022-10-25

Family

ID=83678962

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202210933757.0A Pending CN115227464A (en) 2022-08-04 2022-08-04 Pressure measuring device, preparation method and pressure measuring equipment

Country Status (1)

Country Link
CN (1) CN115227464A (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115414104A (en) * 2022-11-04 2022-12-02 清华大学 Posterior approach spine fixing rod and monitoring system for strain of fixing rod caused by spine stress
CN115414107A (en) * 2022-11-04 2022-12-02 清华大学 Bone fracture plate for orthopedics department, system and method for monitoring skeletal strain of human body and storage medium

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115414104A (en) * 2022-11-04 2022-12-02 清华大学 Posterior approach spine fixing rod and monitoring system for strain of fixing rod caused by spine stress
CN115414107A (en) * 2022-11-04 2022-12-02 清华大学 Bone fracture plate for orthopedics department, system and method for monitoring skeletal strain of human body and storage medium

Similar Documents

Publication Publication Date Title
CN115227464A (en) Pressure measuring device, preparation method and pressure measuring equipment
US10595975B2 (en) Capacitive sensor array for dental occlusion monitoring
US20020180605A1 (en) Wearable biomonitor with flexible thinned integrated circuit
US4629424A (en) Intraoral ambient sensing device
US20050096513A1 (en) Wearable biomonitor with flexible thinned integrated circuit
CN105553323B (en) Physiological monitoring sensing belt and manufacturing method thereof, physiological monitoring mattress and monitoring system
EP2230997B1 (en) An adhesive patch for monitoring acoustic signals
Beebe et al. A silicon-based tactile sensor for finger-mounted applications
EP3727248B1 (en) Devices and method for bruxism management
US7347826B1 (en) Packaging sensors for long term implant
WO2003065926A2 (en) Wearable biomonitor with flexible thinned integrated circuit
EP1465700A2 (en) Neural prosthetic micro system
KR101865650B1 (en) Piezo-electric pulse system using flexible piezo-electric pulse device
Baek et al. Interconnection of multichannel polyimide electrodes using anisotropic conductive films (ACFs) for biomedical applications
US20180256093A1 (en) Diagnostic apparatus
Arx et al. Hermeticity testing of glass-silicon packages with on chip feed throughs
DE102021208524A1 (en) FLEXIBLE TEMPERATURE DETECTION DEVICES FOR BODY TEMPERATURE DETECTION
Seo Design of Ultrasonic Power Link for Neural Dust
Peters et al. Insole embedded lead zirconate-titanate film force sensor array
KR20200057249A (en) Pulse sensing module, blood pressure calculation module, blood pressure measuring device and method for manufacturing pulse sensing module
US20220151528A1 (en) Systems and methods for measuring stress levels
US11272851B2 (en) Pulse sensing module, blood pressure calculation module, blood pressure measuring device and method for manufacturing pulse sensing module
Sun et al. A Micro-fabricated flexible and flat polyimide module with highly C-axis oriented AlN piezoelectric element for accurate vital signs monitoring
WO2008085157A1 (en) Non-invasive blood flow monitor
Ko et al. System integration and packaging

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination