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Patent Analysis of

Method, apparatus, and a system for facilitating bending of an instrument in a surgical or medical robotic environment

Updated Time 12 June 2019

Patent Registration Data

Publication Number

US10149720

Application Number

US14/201610

Application Date

07 March 2014

Publication Date

11 December 2018

Current Assignee

AURIS HEALTH, INC.

Original Assignee (Applicant)

AURIS SURGICAL ROBOTICS, INC.

International Classification

A61B1/008,A61B34/30,A61B1/005,A61B17/00,A61M25/01

Cooperative Classification

A61B1/0055,A61B1/0056,A61B17/00234,A61B34/30,A61M25/0138

Inventor

ROMO, ENRIQUE

Patent Images

This patent contains figures and images illustrating the invention and its embodiment.

US10149720 Method, apparatus, 1 US10149720 Method, apparatus, 2 US10149720 Method, apparatus, 3
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Abstract

An instrument that facilitates bending with large degrees of articulation while maintaining ease of manufacturing for medical and surgical applications is discussed.

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Claims

1. A bending section to carry a tool for use in noninvasive medical procedures, the bending section comprising:

an actuation wire; a rod having an approximately cylindrical outer circumference and a neutral axis; a top portion along a length of the rod; a bottom portion along the length of the rod, wherein at least a section of the bottom portion of the cylindrical rod is formed without material; a non-cylindrical channel through the entire rod, the non-cylindrical channel comprising a top pathway along the top portion and proximate the neutral axis, a bottom pathway along the bottom portion and off-axis from the neutral axis, and a narrowed region therebetween connecting the top and bottom pathways, wherein the rod has a greater wall thickness at the narrowed region than at the top and bottom pathways, wherein the actuation wire is positioned within the bottom pathway to articulate the rod, wherein the actuation wire is in contact with a surface that forms the non-cylindrical channel, and wherein the top pathway is configured to accommodate at least one ancillary component to be in proximity to the neutral axis of the rod; a plurality of first sections alternatingly adjacent to a plurality of second sections along the length of the rod, wherein the plurality of first sections is formed without material to form a plurality of partial voids next to the plurality of second sections, such that the partial voids permit bending of the rod along the top portion of rod.

2. The bending section of claim 1 wherein the non-cylindrical channel comprises a joined dual circle or joined dual oval shaped lumen that accommodates the at least one ancillary component and the off-axis actuation wire, respectively, and wherein each of the top and bottom pathways comprise a single circle or a single oval shape.

3. The bending section of claim 1 wherein the off-axis actuation wire comprises a pull wire.

4. The bending section of claim 1 wherein the at least one ancillary component is one or more of a pull wire, an actuation wire for an end effector, an optical fiber, an electrical wire, a pneumatic component, a hydraulic component, an open lumen, or a telescoping tube.

5. The bending section of claim 1 wherein the cross section of the rod material facilitates increased stiffness support relative to that possible with a constant wall thickness.

6. The bending section of claim 1 wherein the first sections that are formed without material are teardrop shaped.

7. The bending section of claim 1 wherein the second sections that are next to the first sections are leaf shaped as defined by adjacent tear-shaped cutouts from the first sections.

8. The bending section of claim 1 wherein the rod is formed from a superplastic material.

9. The bending section of claim 8 wherein the superplastic material comprises Nitinol.

10. An apparatus to facilitate bending of an instrument comprising:

an actuation wire; a rod with a non-cylindrical lumen; the rod with a first and a second cross sectional shape of the rod lumen, the first configured to facilitate a bend and to accommodate the actuation wire, the actuation wire being positioned within the rod at the first cross sectional shape, the actuation wire being in contact with a surface that forms the non-cylindrical lumen and configured to articulate the rod; and the second to facilitate at least one ancillary component to be in proximity to a neutral axis of the rod, wherein the first and the second cross-sectional shapes are open to one another with a narrowed region therebetween, the rod having a greater wall thickness at the narrowed region than at the top and bottom pathways, and wherein the non-cylindrical lumen is a joined dual oval or joined dual circle shaped lumen that accommodates the ancillary component and actuation wire, wherein each of the first and second cross-sectional shapes comprise a single oval or a single circle shape.

11. The apparatus of claim 10 wherein the cross section of the rod material facilitates increased stiffness support relative to that possible with a constant wall thickness.

12. The apparatus of claim 10 wherein the rod is formed from a superplastic material.

13. The apparatus of claim 12, wherein the superplastic material comprises Nitinol.

14. An apparatus to facilitate bending of an instrument comprising:

an actuation wire; a rod with a non-cylindrical channel and a neutral axis, the rod with a first and a second cross-section of the rod, to facilitate a bend and to accommodate the actuation wire; and the non-cylindrical channel comprising a first pathway to facilitate at least one ancillary component to be in proximity to the neutral axis of the rod and a second pathway open to the first pathway with a narrowed region therebetween, the rod having a greater wall thickness at the narrowed region than at the top and bottom pathways, wherein the apparatus is coupled to an end effector, and wherein the actuation wire is positioned within the second pathway to articulate the rod, the actuation wire being in contact with a surface that forms the non-cylindrical channel, and wherein the first and second pathways form a dual oval or a dual circle shaped lumen that accommodates the ancillary component and actuation wire, the first pathway comprising a single first oval or a single first circle to accommodate the ancillary component and the second pathway comprising a single second oval or a single second circle to accommodate the actuation wire.

15. The apparatus of claim 14 wherein the second cross section facilitates increased stiffness support relative to the first cross section.

16. The apparatus of claim 14 wherein the rod is formed from a superplastic material.

17. The apparatus of claim 16, wherein the superplastic material comprises Nitinol.

18. The apparatus of claim 14 wherein the at least one ancillary component is one or more of a pull wire, an actuation wire for the end effector, an optical fiber, an electrical wire, a pneumatic component, a hydraulic component, an open lumen, or a telescoping tube.

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Claim Tree

  • 1
    1. A bending section to carry a tool for use in noninvasive medical procedures, the bending section comprising:
    • an actuation wire
    • a rod having an approximately cylindrical outer circumference and a neutral axis
    • a top portion along a length of the rod
    • a bottom portion along the length of the rod, wherein at least a section of the bottom portion of the cylindrical rod is formed without material
    • a non-cylindrical channel through the entire rod, the non-cylindrical channel comprising a top pathway along the top portion and proximate the neutral axis, a bottom pathway along the bottom portion and off-axis from the neutral axis, and a narrowed region therebetween connecting the top and bottom pathways, wherein the rod has a greater wall thickness at the narrowed region than at the top and bottom pathways, wherein the actuation wire is positioned within the bottom pathway to articulate the rod, wherein the actuation wire is in contact with a surface that forms the non-cylindrical channel, and wherein the top pathway is configured to accommodate at least one ancillary component to be in proximity to the neutral axis of the rod
    • a plurality of first sections alternatingly adjacent to a plurality of second sections along the length of the rod, wherein the plurality of first sections is formed without material to form a plurality of partial voids next to the plurality of second sections, such that the partial voids permit bending of the rod along the top portion of rod.
    • 2. The bending section of claim 1 wherein
      • the non-cylindrical channel comprises
    • 3. The bending section of claim 1 wherein
      • the off-axis actuation wire comprises
    • 4. The bending section of claim 1 wherein
      • the at least one ancillary component is one or more of a pull wire, an actuation wire for an end effector, an optical fiber, an electrical wire, a pneumatic component, a hydraulic component, an open lumen, or a telescoping tube.
    • 5. The bending section of claim 1 wherein
      • the cross section of the rod material facilitates increased stiffness support relative to that possible with a constant wall thickness.
    • 6. The bending section of claim 1 wherein
      • the first sections that are formed without material are teardrop shaped.
    • 7. The bending section of claim 1 wherein
      • the second sections that are next to the first sections are leaf shaped as defined by adjacent tear-shaped cutouts from the first sections.
    • 8. The bending section of claim 1 wherein
      • the rod is formed from a superplastic material.
  • 10
    10. An apparatus to facilitate bending of an instrument comprising:
    • an actuation wire
    • a rod with a non-cylindrical lumen
    • the rod with a first and a second cross sectional shape of the rod lumen, the first configured to facilitate a bend and to accommodate the actuation wire, the actuation wire being positioned within the rod at the first cross sectional shape, the actuation wire being in contact with a surface that forms the non-cylindrical lumen and configured to articulate the rod
    • and the second to facilitate at least one ancillary component to be in proximity to a neutral axis of the rod, wherein the first and the second cross-sectional shapes are open to one another with a narrowed region therebetween, the rod having a greater wall thickness at the narrowed region than at the top and bottom pathways, and wherein the non-cylindrical lumen is a joined dual oval or joined dual circle shaped lumen that accommodates the ancillary component and actuation wire, wherein each of the first and second cross-sectional shapes comprise a single oval or a single circle shape.
    • 11. The apparatus of claim 10 wherein
      • the cross section of the rod material facilitates increased stiffness support relative to that possible with a constant wall thickness.
    • 12. The apparatus of claim 10 wherein
      • the rod is formed from a superplastic material.
  • 14
    14. An apparatus to facilitate bending of an instrument comprising:
    • an actuation wire
    • a rod with a non-cylindrical channel and a neutral axis, the rod with a first and a second cross-section of the rod, to facilitate a bend and to accommodate the actuation wire
    • and the non-cylindrical channel comprising a first pathway to facilitate at least one ancillary component to be in proximity to the neutral axis of the rod and a second pathway open to the first pathway with a narrowed region therebetween, the rod having a greater wall thickness at the narrowed region than at the top and bottom pathways, wherein the apparatus is coupled to an end effector, and wherein the actuation wire is positioned within the second pathway to articulate the rod, the actuation wire being in contact with a surface that forms the non-cylindrical channel, and wherein the first and second pathways form a dual oval or a dual circle shaped lumen that accommodates the ancillary component and actuation wire, the first pathway comprising a single first oval or a single first circle to accommodate the ancillary component and the second pathway comprising a single second oval or a single second circle to accommodate the actuation wire.
    • 15. The apparatus of claim 14 wherein
      • the second cross section facilitates increased stiffness support relative to the first cross section.
    • 16. The apparatus of claim 14 wherein
      • the rod is formed from a superplastic material.
    • 18. The apparatus of claim 14 wherein
      • the at least one ancillary component is one or more of a pull wire, an actuation wire for the end effector, an optical fiber, an electrical wire, a pneumatic component, a hydraulic component, an open lumen, or a telescoping tube.
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Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

The field of the present application pertains to medical devices. More particularly, the field of the invention pertains to an apparatus, system, and method for performing surgery.

2. Description of the Related Art

Robotic surgery has many benefits to improve patient recovery time and allows precise control of medical and surgical application instruments. In robotics, an end effector is the device at the end of a robotic arm, designed to interact with the environment. The exact nature of this device depends on the application of the robot. For example, several examples of end effectors could include a set of forceps, a pair of scissors, a laser, a camera, a cautery tool, a needle, or any other instrument tip that would benefit from being able to be repositioned.

As previously discussed, which originates from serial robotic manipulators, the end effector means the last link (or end) of the robot. At this endpoint the tools are attached. In a wider sense, an end effector can be seen as the part of a robot that interacts with the work environment.

Many articulating devices use bending sections comprising many small moving parts for creating an assembly. Typically, the assemblies are difficult to manufacture in smaller geometries since the individual components become difficult to fabricate.

Another challenge with existing solutions is accommodating the ancillary components for the end effector; which may include pull wire, electrical wires, fluidic lines, and optical fibers. The location of these components within the bending section impacts performance and stability of the bending section. All beams have an imaginary line within the body what will remain the same length when straight or bent, this line is termed the Neutral Axis of the structure. The neutral axis region does not experience any strain or stress. Typically, material that falls on either side of this line will experience strain and will either be extended or compressed. The inside of the bend will compress and the outside of the bend will extend. See FIG. 1 for an illustration of the neutral axis along with its relationship to the inner and outer bend surfaces.

For example, if the ancillary components are placed outside of the neutral axis region, they will slide in and out of the bending section if they are able to float relative to the bending section. Otherwise, the components will buckle or stretch due to the axial forces being imposed. FIG. 2 depicts an illustration of the relationship of components placed away from the components neutral axis.

Existing solutions for bending sections are created for small articulable instruments that is manufactured from thin walled tube. For example, intricate patterns are cut into the tubing in order to create reliefs that yield a preferential bending direction. However, if a large deflection is required; much of the tubing material will need to be removed in order to allow for such bending. Consequently, a thin walled tube with lots of its material eliminated inevitably loses much of the structure and ability to remain mechanically stable.

Therefore, it would be advantageous to have a method and apparatus for facilitating the bending of an instrument with large degrees of articulation while maintaining a sufficient amount of stiffness in order to provide stability at the end effector, all while ensuring ease of manufacturing.

SUMMARY OF THE INVENTION

Embodiments described herein are directed to a method, apparatus, and system for bending of an instrument with large degrees of articulation while maintaining ease of manufacturing.

In other embodiments, methods and apparatus for creating an articulating segment by starting with a solid rod instead of a tube. First, material is removed from the sides of the rod for enabling a bend. In one embodiment, the rod has material removed from the cross section in order to accommodate an actuation wire.

In other embodiments, the cross section accommodates ancillary components pertaining to the end effector.

One embodiment provides placing the path of the ancillary components close to the neutral axis of the bending section. Consequently, this reduces interactions between the articulation of the bending section and the ancillary components. Furthermore, resulting in a more predictable bend and end effector behavior. For example and not by way of limitation, removing material from the cross section to accommodate the articulation pull wire and the ancillary components permits manipulation of bending stiffness and the amount of opposing forces it is able to resolve during a medical procedure.

In one embodiment, the component is manufactured from a superplastic material that will be discussed later, such as, but not limited to Nitinol and other similar materials. The stiffness of the structure was manipulated via the design of the cross sectional profile in order to ensure the structure provides enough stability throughout the complete range of motion. The structure achieves a significant bend by imposing a moment on the structure and will recover to the original position when the moment is removed from the structure.

This actuation would simply require one pull wire at the tip, which would need to be pulled in order to generate a moment and relaxed to relieve the moment.

In an alternative embodiment, the component is manufactured from a superplastic material, but the cross section allows a different inner profile by incorporating the relief on the profile, the device lends itself to be manufactured using the wire EDM (Electric Discharge Machining) process without having to initially create a clearance hole.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view to facilitate description of a neutral axis;

FIG. 2 is a view to facilitate description of a neutral axis;

FIGS. 3A-3D depict an apparatus for a bending flexure according to a first embodiment of the present invention;

FIG. 4 is a cross section side view of FIG. 3;

FIG. 5 is a view of a modeling representation of FIG. 3 according to a finite element analysis (FEA);

FIG. 6 is a view depicted an articulated position of the first embodiment depicted in FIG. 3;

FIG. 7 is an isometric view of an assembly, wherein the flexure subject matter is incorporated into an end effector, according to one embodiment of the present invention;

FIG. 8 depicts an apparatus for a bending flexure according to a second embodiment of the present invention;

FIG. 9 is a cross section side view of FIG. 8; and

FIG. 10 is a cross section side view that depicts bending behavior of FIG. 9.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components.

For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

The embodiments described herein are directed to an apparatus for a distal bending section of minimally invasive surgical instrument having a large degree of articulation and providing sufficient rigidity to resolve the required forces during remote surgical procedures. Other embodiments provide methods of using the distal bending section and methods for making it.

One embodiment provides placing the path of the ancillary components close to the neutral axis of the bending section. Consequently, this reduces interactions between the articulation of the bending section and the ancillary components. Furthermore, embodiments of the present invention provide a more predictable bend and end effector behavior. For example and not by way of limitation, removing material from the cross section accommodates the articulation pull wire and the ancillary components, hence, the bending stiffness can be manipulated in order to achieve a desired characteristic.

In one embodiment, the component is manufactured from a superplastic material. In one embodiment, the material is Nitinol and with superelastic phase at room and/or body temperature. Also, other embodiments include use of any super elastic alloy. In yet another embodiment, the moment of inertia was tuned such that the structure achieves a significant bend by generating a moment on the structure and recovers to the original position when the moment is removed. This actuation would simply require one pull wire at the tip, which would need to be pulled in order to generate a moment and relaxed to relieve the moment.

In an alternative embodiment, the component is manufactured from a superplastic material, but the cross section allows a different inner profile by incorporating the relief on the profile, the device lends itself to be manufactured using the wire EDM (Electric Discharge Machining) process without having to initially create a clearance hole.

Referring to FIG. 3A, finished bending section 300 in accordance to an embodiment of the present invention is depicted. FIG. 3B is a longitudinal cross-section through the axis of bending section 300, FIG. 3C shows an axial cross-section of bending section 300 along line C of FIG. 3B, and FIG. 3D shows an axial cross-section of bending section 300 along line D of FIG. 3B.

Referring to FIG. 3B, material is removed along the top portion of a rod to create void 302, preferably along the length of the bending section. As discussed below, this void is created to assist in removal of material in the road to create the additional features of this preferred embodiment. Material is also removed from teardrop sections 304, where adjacent to teardrop section 304 material is left in place forming leaves 306. A tendon (not shown) extends through void 308 (described below) is attached at the distal end of bending section 300. When tension is applied to the tendon bending section will bend downward, as shown in the figure, and teardrop voids 304 permit leaves 306 to move inward, and a bend is realized along solid spine 310. The skilled artisan will appreciate the selection of shapes for the teardrop voids and leaves is a matter of design choice, as well as the amount of material left to form spine 310.

Referring now to FIG. 3C, non-cylindrical channel 312 is formed down the length of the solid rod. Preferably the outer circumference of the rod, and therefore the bending section, has an approximately cylindrical shape, similar to that of a drawn hypotube. Prior art bending sections have material cut from a hypotube, and therefore have a cylindrical inner diameter as well, which results is a uniform sidewall thickness along the length of the prior art bending section. When the outer diameter of the bending section is small, the hypotube walls do not provide sufficient strength and rigidity when large degree articulations are required and where a surgical tool at the distal end requires this rigidity to perform desired procedures. Embodiments of the present invention provide a non cylindrical channel 312 through the bending section, which permits distributing material off-axis (i.e., non-uniform wall thickness) to provide structural rigidity to the bending section, provides a pathway 314 for the tendon off-axis and a pathway 316 proximate to the neutral axis for auxiliary cables (not shown), such as tool actuating or articulating cables.

One embodiment provides for placing the path of the ancillary components as close to the neutral axis of the bending section. Consequently, this reduces interactions between the articulation of the bending section and the ancillary components. Furthermore, this embodiment provides a more predictable bend and end effector behavior. For example, removing enough material from the cross section to accommodate the articulation pull wire and the ancillary components, hence, the bending stiffness can be manipulated in order to achieve a desired characteristic. FIG. 4 is a cross section the same as shown in FIG. 3C. The location of the cross section locations relative to the structure are illustrated in FIG. 5. Section c-c demonstrates the cross section of the region 310 that will experience the bend and will contribute to the deflection of the structure. Section d-d demonstrates the region of the structure that provides a chassis 316, similar to a ribcage, to supports and house the components that are required to articulate the structure and manipulate the end effector. In this Figure, the hatched diagonal sections (referred to as hatched regions) depict a solid cross section. For example, section c-c has a solid cross section on the top portion. In contrast, section d-d has a solid cross section around the entire channel.

A dashed line near the top of the figure depicts the neutral axis of the apparatus. Also, a dashed arrow depicts the direction of the preferential bending away from the neutral axis in a downward direction.

Both section views of section c-c and d-d depict a dual oval shaped key opening, or lumen, to accommodate ancillary components (not shown) and an articulation wire (not shown). In some embodiments, the ancillary components could include any or all of the following:

    • Pull wires for generating actuation at the end effector;
    • Fibers for Illumination, laser, vision;
    • Pneumatics and/or hydraulics;
    • Electrical wires;
    • Open lumen for a working channel (open architecture device, end effector is passed through working channel and is interchangeable); and
    • A telescoping tube that supports the end effector

In one embodiment, the top opening, or lumen, accommodates the ancillary components and the bottom opening accommodates the articulating wire that controls the bending of the apparatus. However, the skilled artisan appreciates different lumen configurations and placements based at least in part on the medical, surgical, or other application of the bending apparatus may be used without deviating from the present invention.

FIG. 5 is a view of a modeling representation of FIG. 3 according to a finite element analysis (FEA) which shows the interaction between the articulation wire and the flexure.

FIG. 6 is a view depicting an articulated position of the the embodiment depicted in FIGS. 3-4. This photograph was captured under a microscope and exemplifies the uniform bending of the structure. In one embodiment, the degree of articulation is based at least in part on the amount of reliefs/voids along the length of the structure. In this embodiment, one aspect of the relief also allows the structure a hard stop (a feedback of hitting a barrier) when the leaves come in contact. Consequently, embodiments of the present invention help to prevent over articulation and potential damage to the structure.

FIG. 7 is an isometric view of an assembly, wherein the flexure subject matter is incorporated into an end effector, according to one embodiment of the claimed subject matter in the present invention;

FIG. 8 depicts an apparatus for a bending flexure according to another embodiment of the present invention. The skilled artisan will appreciate the shape of non-cylindrical channel 312 can be varied to achieve desired bending and rigidity properties of the bending section. The cross section of the design depicted in FIG. 8 (shown in FIG. 9), permits the inner profile to break out. By incorporating this relief on the profile, the device lends itself to be manufactured using the wire EDM process without having to initially create a clearance hole

FIG. 9 is a cross section side view of FIG. 8. The two struts 702 on flexure #2 (FIG. 7) tend to bend about the neutral axis, but also slightly into the center of the cross section. This bending characteristic will result in the break out “gap” to start to close as the flexure is articulated, and will eventually close completely during large articulations.

Also, in this second embodiment, an opening allows for lateral insertion of ancillary components. The concept of having a break out on the inner profile also has a benefit during the assembly process. For example, there is an available gap through the piece, the articulation wire and ancillary components can be inserted laterally instead of axially. This assembly option also allows the flexure to replaced without having to sever the articulation wire.

FIG. 10 is a cross section side view that depicts bending behavior of the embodiment depicted in FIG. 8-9. During operation, the gap will tend to close as the flexure is articulated and will therefore minimize the possibility of having the ancillary components “escape” the inner profile lumens. If the presence of the gap is of concern, the component can still be manufactured with a gap and then “shape set” in order to close the gap before integration into an assembly.

Elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein. While the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. The invention is not limited, however, to the particular forms or methods disclosed, but to the contrary, covers all modifications, equivalents and alternatives thereof.

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Citation

Patents Cited in This Cited by
Title Current Assignee Application Date Publication Date
手術装置 株式会社スギノマシン 12 March 1996 02 September 1997
动脉斑块旋切术装置和方法 阿瑟罗迈德公司 10 April 2009 08 June 2011
血管外組織構造をリモデリングするための方法および装置 EDWARDS LIFESCIENCES AG 17 September 2010 27 January 2011
医療用マニピュレータ及び実験装置 TERUMO CORP 25 August 2008 04 March 2010
Steerable flexible elongate device and method for use therewith INTELLIWIRE, INC. 05 November 1992 26 May 1993
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US10149720 Method, apparatus, 1 US10149720 Method, apparatus, 2 US10149720 Method, apparatus, 3