阅读说明：本技术 医疗器械校正 (Medical device calibration ) 是由 Y.阿尔加维 A.戈瓦里 I.斯特尼茨基 于 2020-04-03 设计创作，主要内容包括：本发明题为“医疗器械校正”。本发明提供了一种校正设备,在一个实施方案中,该校正设备包括：夹具主体；相机；可偏转且有回弹力的细长条；下槽,该下槽设置在夹具主体中,并且被构造成能够在其中容纳并夹紧相机；上槽,该上槽设置在夹具主体中的下槽上方,并且被构造成能够在其中容纳并夹紧细长条,以便将细长条定位在相对于相机固定的上方位置,上槽比下槽更宽；和对齐元件,该对齐元件设置在夹具主体中,并且被构造成能够将相机的端部与细长条的端部对齐。(The invention provides medical device calibration. The present invention provides a correction device, which in one embodiment comprises: a clamp body; a camera; a deflectable and resilient elongate strip; a lower groove provided in the jig main body and configured to be able to receive and clamp the camera therein; an upper channel disposed above the lower channel in the clamp body and configured to receive and clamp the elongated strip therein to position the elongated strip in a fixed upper position relative to the camera, the upper channel being wider than the lower channel; and an alignment element disposed in the jig body and configured to align an end of the camera with an end of the elongated strip.)

1. A correction device, comprising:

a clamp body;

a camera;

a deflectable and resilient elongate strip;

a lower groove provided in the jig body and configured to receive and clamp the camera therein;

an upper channel disposed in the clamp body above the lower channel and configured to receive and clamp the sliver therein to position the sliver above and in a fixed relationship relative to the camera, the upper channel being wider than the lower channel; and

an alignment element disposed in the jig body and configured to align an end of the camera with an end of the elongated strip.

2. The apparatus of claim 1, wherein: the lower trough has a width in the range of 0.5mm to 2mm and a height in the range of 0.5mm to 2 mm; and the upper groove has a width ranging from 1mm to 6 mm.

3. The apparatus of claim 1, wherein the lower slot comprises a first section having a first width configured to receive and clamp the camera therein and a second section having a second width wider than the first width, the second section configured to receive a connector and a cable extending from the camera, the first width ranging from 0.5mm to 2 mm.

4. The apparatus of claim 1, wherein the alignment element comprises an alignment post disposed in the lower slot and extending at least upwardly into the upper slot.

5. The apparatus of claim 1, wherein the upper tank is centrally disposed above the lower tank.

6. The apparatus of claim 1, wherein the upper groove has a height in the range of 0.05mm to 0.15 mm.

7. The apparatus of claim 1, wherein the clamp body includes at least one side groove extending from the lower groove to exit at a side of the clamp body and configured to receive a cable extending from the camera therein.

8. The apparatus of claim 1, wherein the surfaces of the lower and upper troughs comprise Polytetrafluoroethylene (PTFE) or Polyoxymethylene (POM).

9. The apparatus of claim 1, wherein the elongate strip comprises nitinol.

10. A medical device assembly method, comprising:

disposing a camera in a lower slot of a clamp body, wherein an end of the camera abuts an alignment element of the clamp body such that the lower slot clamps the camera therein;

disposing a deflectable and resilient elongate strip in an upper channel of the clamp body, wherein an end of the elongate strip abuts the alignment element such that the upper channel clamps the elongate strip above and in fixed relation to the camera, the upper channel being wider than the lower channel;

applying an adhesive between the camera and the sliver to mechanically connect the camera and the sliver;

removing the connected camera and sliver from the jig body; and

the connected camera and sliver are disposed in a medical instrument.

11. The method of claim 10, wherein: the lower trough has a width in the range of 0.5mm to 2mm and a height in the range of 0.5mm to 2 mm; and the upper groove has a width in the range of 1mm to 6 mm.

12. The method of claim 10, wherein the elongated strip comprises an aperture, wherein the applying is performed by applying the adhesive through the aperture.

13. The method of claim 10, further comprising disposing a cable extending from the camera in at least one side slot of the clamp body, the at least one side slot extending from the lower slot to exit at a side of the clamp body.

14. The method of claim 10, wherein the elongate strip comprises nitinol.

15. The method of claim 10, further comprising disposing a light emitting diode in the medical instrument.

16. The method of claim 10, further comprising disposing at least one irrigation tube in the medical instrument.

17. The method of claim 10, wherein the lower slot includes a first section having a first width configured to receive and clamp the camera therein and a second section having a second width wider than the first width, the second section configured to receive a connector and a cable extending from the camera, the first width ranging from 0.5mm to 2 mm.

18. The method of claim 10, wherein the alignment element comprises an alignment post disposed in the lower slot and extending at least upwardly into the upper slot.

19. The method of claim 10, wherein the upper trough is centrally disposed above the lower trough.

20. The method of claim 10, wherein the upper groove has a height in the range of 0.05mm to 0.15 mm.

21. The method of claim 10, wherein the surfaces of the lower and upper troughs comprise Polytetrafluoroethylene (PTFE) or Polyoxymethylene (POM).

Technical Field

The present invention relates to medical devices and in particular, but not exclusively, to components of medical devices.

Background

Medical instruments, such as, but not limited to, catheters, probes, and other instruments such as ENT tools, may include miniature cameras for capturing images of the inside of a living subject. To provide useful data, the image capture device typically needs to be calibrated after the medical instrument is assembled prior to initial use.

U.S. patent publication 2013/0281821(Liu et al) describes a surgical navigation system that employs an endoscope and an imaging unit. The endoscope includes an electromagnetic tracker within the endoscope working channel for generating electromagnetic sensing signals indicative of one or more gestures of the endoscope within the anatomical region; and an endoscopic camera within the endoscopic imaging channel for generating an endoscopic image of the anatomical region. The imaging unit performs intra-operative correction of the electromagnetic tracker and the endoscopic camera according to image registration between a pre-operative scan image of a correction site within the anatomical region and one or more endoscopic images of the correction site within the anatomical region.

Us patent 9,188,973(Tenney et al) describes a system and method that determines a mapping between a first camera system coordinate system and a second camera system coordinate system; or determining a transformation between the robot coordinate system and the camera system coordinate system and/or positioning a tool extending from the robot arm in the robot coordinate system based on the tool position in the camera coordinate system. The disclosed systems and methods may use a transformation derived from the coordinates of features found in one or more images. The transformation may be used to correlate various coordinate systems to facilitate calibration of camera systems, including camera systems in robotic systems, such as image-guided robotic systems for hair removal and/or implantation.

Disclosure of Invention

According to an embodiment of the present disclosure, there is provided a correction apparatus including: a clamp body; a camera; a deflectable and resilient elongate strip; a lower groove provided in the jig main body and configured to be able to receive and clamp the camera therein; an upper channel disposed above the lower channel in the clamp body and configured to receive and clamp the sliver therein so as to position the sliver in a fixed upper position relative to the camera, the upper channel being wider than the lower channel; and an alignment element disposed in the jig body and configured to align an end of the camera with an end of the elongated strip.

Also in accordance with an embodiment of the present disclosure, the lower groove has a width ranging from 0.5mm to 2mm and a height ranging from 0.5mm to 2mm, and the upper groove has a width ranging from 1mm to 6 mm.

Still further in accordance with an embodiment of the present disclosure, the lower channel includes a first section having a first width and a second section having a second width wider than the first width, the first section configured to receive and clamp the camera therein, the second section configured to receive a connector and a cable extending from the camera, the first width ranging from 0.5mm to 2 mm.

Additionally, according to one embodiment of the present disclosure, the alignment element includes an alignment post disposed in the lower slot and extending at least upwardly into the upper slot.

Further, according to an embodiment of the present disclosure, the upper trough is centrally disposed above the lower trough.

Also in accordance with an embodiment of the present disclosure, the upper groove has a height ranging from 0.05mm to 0.15 mm.

Still further in accordance with an embodiment of the present disclosure, the clip body includes at least one side groove extending from the lower groove to exit at a side of the clip body and configured to accommodate therein a cable extending from the camera.

Further, according to an embodiment of the present disclosure, the surfaces of the lower tank and the upper tank comprise Polytetrafluoroethylene (PTFE) or Polyoxymethylene (POM).

Further, according to an embodiment of the present disclosure, the elongate strip comprises nitinol.

There is also provided, in accordance with another embodiment of the present disclosure, a medical device assembly method, including: disposing a camera in a lower slot of a clamp body, wherein an end of the camera abuts an alignment element of the clamp body such that the lower slot clamps the camera therein; disposing a deflectable and resilient elongate strip in an upper channel of the clamp body, wherein an end of the elongate strip abuts the alignment element such that the upper channel clamps the elongate strip in a fixed upper position relative to the camera, the upper channel being wider than the lower channel; applying an adhesive between the camera and the sliver to mechanically connect the camera and the sliver; removing the connected camera and sliver from the jig body; and disposing the connected camera and sliver in a medical instrument.

Also in accordance with an embodiment of the present disclosure, the lower groove has a width ranging from 0.5mm to 2mm and a height ranging from 0.5mm to 2mm, and the upper groove has a width ranging from 1mm to 6 mm.

Still further in accordance with an embodiment of the present disclosure, the elongated strip includes an aperture, wherein the applying is performed by: applying the adhesive through the aperture.

Additionally, according to one embodiment of the present disclosure, the method includes disposing a cable extending from the camera in at least one side groove of the clamp body, the side groove extending from the lower groove to exit at a side of the clamp body.

Further, according to an embodiment of the present disclosure, the elongate strip comprises nitinol.

Also in accordance with an embodiment of the present disclosure, the method includes disposing a light emitting diode in the medical instrument.

Still further in accordance with an embodiment of the present disclosure, the method includes disposing at least one irrigation tube in the medical instrument.

Further, according to an embodiment of the present disclosure, the lower groove includes a first section having a first width configured to receive and clamp the camera therein and a second section having a second width wider than the first width configured to receive a connector and a cable extending from the camera, the first width ranging from 0.5mm to 2 mm.

Further, according to one embodiment of the present disclosure, the alignment element includes an alignment post disposed in the lower slot and extending at least upwardly into the upper slot.

Further, according to an embodiment of the present disclosure, the upper trough is centrally disposed above the lower trough.

Still further in accordance with an embodiment of the present disclosure, the upper groove has a height ranging from 0.05mm to 0.15 mm.

Further, according to an embodiment of the present disclosure, the surfaces of the lower tank and the upper tank comprise Polytetrafluoroethylene (PTFE) or Polyoxymethylene (POM).

Drawings

The present invention will be understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a schematic illustration of a medical device constructed and operative in accordance with an embodiment of the present invention;

FIG. 2 is a schematic illustration of a calibration apparatus constructed and operative in accordance with an embodiment of the present invention;

FIG. 3 is a schematic view of the calibration apparatus of FIG. 2 with a camera disposed therein;

FIG. 4 is a schematic view of the calibration apparatus of FIG. 3 with an elongated strip positioned on top of the camera; and is

Fig. 5 is a flow chart including exemplary steps in the medical device assembly method of fig. 1.

Detailed Description

SUMMARY

As previously mentioned, medical instruments, such as, but not limited to, catheters, probes, and other medical instruments such as ENT tools, may include miniature cameras for capturing images of the inside of a living subject. To provide useful data, the image capture device typically needs to be calibrated after the medical instrument is assembled and before initial use. The calibration process can be time consuming and expensive. In some cases, post-assembly correction may be difficult, or even impossible.

Embodiments of the present invention provide a method of efficiently and accurately (and at a lower cost relative to methods known in the art) assembling a medical instrument having a camera using a calibration apparatus that includes a clamp body. The method allows the camera to be mechanically connected to the substantially deflectable and resilient elongated strip with a predetermined orientation and relative position within a given accuracy, such that the frames captured by the camera are substantially the same (within set correction limits) as the frames captured by other cameras and strips connected by the same method and correction device. Once a camera-bar combination is corrected, subsequent camera-bar combinations typically require no further correction or less correction. The elongate strip provides a base for the camera and other proximal components of the medical instrument described in more detail below. An elongate strip with a camera (and optionally other components) is disposed in the guidewire. The positioning of the elongate strip in the guide wire determines the direction in which the medical device can be deflected.

The clamp body includes various recesses for inserting the cameras, camera cables and slivers therein. In some embodiments, the size and arrangement of the grooves are set such that the resulting connection between the camera and the sliver is accurate to about 0.1% or 1 micron of the desired connection orientation and position. In other embodiments, the accuracy may be greater or less, such as but not limited to 1% or 10 microns.

A lower slot in the clamp body receives and clamps the camera therein. The lower groove includes a first section and a second section wider than the first section. Receiving and clamping the camera therein is a first section. The second section houses a connector and a cable extending from the camera. In some embodiments, the width of the first section may range from 0.5mm to 2mm, depending on the size of the camera that the first section is intended to clamp. In some embodiments, the height of the lower trough ranges from 0.5mm to 2mm, depending on the size of the camera to be disposed therein. The width and height dimensions are not limited to the exemplary values described above, but may be any suitable values.

The clamp body includes at least one side groove extending from the lower groove to exit from one (or more) sides of the clamp body. The side slots may be curved or straight and receive cables extending from the camera therein.

The upper groove is disposed above the lower groove in the clamp body and generally continues to the end of the clamp body. The upper channel receives and grips the sliver therein to position the sliver in a fixed upper position relative to the camera. The upper channel is wider than the lower channel, which reflects the fact that the sliver is generally wider than the camera. The upper channel can have any suitable width depending on the width of the elongate strip, but in one embodiment the width of the upper channel ranges from 1mm to 6 mm. The upper channel can have any suitable height that is equal to or greater than the thickness of the sliver. In some embodiments, the height of the upper groove ranges from 0.05mm to 0.15 mm. In some embodiments, the upper trough is centrally disposed above the lower trough. However, in other embodiments, the upper slot may be positioned in eccentric alignment depending on the desired orientation of the connection and the position of the camera relative to the elongate strip. As described above, the elongate strip is deflectable and resilient, and may comprise nitinol.

The jig body includes an alignment element disposed in the jig body and for aligning an end of the camera with an end of the elongated strip. In some embodiments, the alignment element includes an alignment post disposed in the lower slot and extending at least upwardly into the upper slot.

Once the camera and sliver are properly positioned in the jig body, adhesive is applied to mechanically connect the camera with the sliver. To prevent the adhesive from sticking the camera and/or the sliver to the holder body, the surfaces of the lower channel, the upper channel, and possibly other parts of the holder body comprise non-stick surfaces, such as Polytetrafluoroethylene (PTFE) or Polyoxymethylene (POM). In some embodiments, the clip body is formed entirely of a non-stick material such as PTFE or POM.

A method of assembling a medical device comprising: disposing a camera in a lower slot of the clamp body, wherein an end of the camera abuts an alignment element of the clamp body such that the lower slot clamps the camera therein; and a cable extending from the camera is disposed in the side groove of the jig main body. The method also includes positioning the elongated strip in an upper channel of the fixture body, wherein an end of the elongated strip abuts the alignment element such that the upper channel clamps the elongated strip in a fixed upper position relative to the camera. The method also includes applying an adhesive between the camera and the sliver to mechanically connect the camera and the sliver. In some embodiments, the elongate strip comprises an aperture, and the adhesive is applied through the aperture. Once the adhesive has sufficient time to sufficiently mechanically connect the elongate strip with the camera, the method includes removing the connected camera and elongate strip from the clip body and disposing the connected camera and elongate strip in the medical instrument. In some embodiments, the light emitting diode and/or the at least one irrigation tube is disposed in the medical device.

Description of the System

Reference is now made to fig. 1, which is a schematic illustration of a medical device 10, constructed and operative in accordance with an embodiment of the invention. The medical device 10 may include a guidewire 20 (such as, but not limited to, a compression coil secured therein), a camera 12 mounted on the elongate strip 14 (only the end of the elongate strip 14 is visible in fig. 1), one or more light emitting diodes 16, and one or more irrigation tubes 18. In some embodiments, the guidewire 20 may be disposed within a suitable sheath (not shown). In some embodiments, the medical device 10 may omit the light emitting diode 16 and/or the irrigation tube 18. In other embodiments, the camera 12 and the elongate strip 14, and optionally the light emitting diode 16 and/or the irrigation tube 18, may be disposed in any suitable medical device, which may or may not include a guidewire 20. By way of example only, the medical instrument may be a medical probe, or a catheter, or any suitable medical instrument such as an ENT tool. The elongate strip 14 provides a base for the camera 12 and other proximal components of the medical instrument 10, such as the light emitting diodes 16 and the irrigation tube 18. The positioning of the elongate strip 14 in the guidewire 20 determines the direction in which the medical device 10 can deflect.

Reference is now made to fig. 2-4. Fig. 2 is a schematic illustration of a calibration apparatus 30 constructed and operative in accordance with an embodiment of the present invention. Fig. 3 is a schematic diagram of the correction device 30 of fig. 2, in which the camera 12 is disposed. Fig. 4 is a schematic view of the correction device 30 of fig. 3, wherein the elongated strip 14 is arranged on top of the camera 12.

The correction device 30 includes a clamp body 32, a lower groove 34, an upper groove 36, and two side grooves 38 disposed in the clamp body 32. In some embodiments, the lower and upper slots 34, 36 follow a straight path from one end of the clamp body 32 to the other.

The lower slot 34 includes a first section 40 and a second section 42. The width of the second section 42 is wider than the width of the first section 40. The first section 40 is configured to receive and clamp the camera 12 therein, as shown in FIG. 3. The second section is configured to accommodate connectors 44 (only some of which are labeled for simplicity) and cables 46 extending from the camera 12, as also shown in fig. 3. The width and height of the first section 40 are sized to receive and clamp the camera 12 therein to ensure that the accuracy of the positioning between the camera 12 and the sliver 14 is within calibration requirements. In some implementations, the difference between the width of the camera 12 and the width of the first section 40 is on the order of micrometers. In some embodiments, the width of the first section 40 of the lower slot 34 ranges from 0.5mm to 2mm, such as 1 mm. The width of the first section 40 of the lower slot 34 may be any suitable width depending on the size and calibration requirements of the camera 12. In some embodiments, the height of the lower groove 34 may range from 0.5mm to 2mm, such as 1 mm. The height (depth) of the lower trough 34 may be any suitable height depending on the size and calibration requirements of the camera 12.

The side slots 38 extend away from the lower slot 34 to exit from either side of the clamp body 32. The side channel 38 is configured to receive a cable 46 extending from the camera 12 therein, as shown in FIG. 3. The side grooves 38 help to keep the cable 46 away from the sliver 14 and prevent the cable 46 from exerting upward pressure on the sliver 14, which may interfere with the correct position between the camera 12 and the sliver 14. In addition, placing the cable 46 in the side channel 38 helps stabilize the camera 12 in the first section 40 of the lower channel 34 and prevents the camera 12 from moving forward or backward in the lower channel 34.

An upper groove 36 is provided in the clamp body 32 above the lower groove 34. The upper channel 36 is configured to receive and grip the elongate strip 14 therein to position the elongate strip 14 in a fixed upper position relative to the camera 12, as shown in fig. 4.

The upper slot 36 is generally wider than the lower slot 34. In some embodiments, the upper trough 36 is centrally disposed above the lower trough 34. In other embodiments, the upper trough 36 may be non-centrally disposed above the lower trough 34.

The lower and upper channels 34, 36 can be considered as a single groove having a T-shaped cross-section and side flanges 52 for resting the elongate strip 14 thereon.

In some embodiments, the width of the upper channel 36 ranges from 1mm to 6mm, for example 3mm, depending on the width of the elongate strip 14. In other embodiments, the upper channel 36 can have any suitable width depending on the width of the elongate strip 14 and the alignment requirements.

In some embodiments, the height (depth) of the upper groove 36 ranges from 0.05mm to 0.15mm, such as 0.08 mm. The height of the upper channel 36 can be set according to the thickness of the elongate strip 14. In other embodiments, the height of the upper channel 36 is not set according to the thickness of the elongate strip 14.

The elongate strip 14 may be longer than the clip body 32. In this case, the upper channel 36 extends to at least one end of the clamp body 32 to allow the elongate strip 14 to extend away from the clamp body 32.

The correction device 30 also includes an alignment element 48 disposed in the jig body 32 and configured to align an end of the camera 12 with an end of the elongate strip 14. In some embodiments, the alignment element 48 comprises an alignment post disposed in the lower slot 34 and extending at least upwardly into the upper slot 36.

As will be described in more detail with reference to fig. 5, the camera 12 and the elongated strip 14 are mechanically connected together using an adhesive. To prevent the adhesive from adhering the camera 12 and/or the elongated strip 14 to the fixture body 32, the surfaces of the lower and upper channels 34, 36 may comprise a non-stick material, such as Polytetrafluoroethylene (PTFE) or Polyoxymethylene (POM), or any other suitable non-stick material. In some embodiments, the clamp body 32 is formed entirely of a non-stick material such as PTFE or POM. The clamp body 32 may be any suitable size.

In some embodiments, the elongate strip 14 includes apertures 50 therein through which adhesive is inserted. The elongate strip 14 may comprise any suitable material such that the elongate strip 14 is deflectable and resilient. In some embodiments, elongate strip 14 is formed entirely of, or partially comprises, nitinol.

Reference is now made to fig. 5, which is a flowchart 60 including exemplary steps in the method of assembling the medical device 10 of fig. 1. See also fig. 1-5. The method of assembling the medical device 10 may include the following steps. Some of these steps may be performed in a different order than described below.

The method includes positioning the camera 12 in the lower slot 34 of the clamp body 32 (block 62), wherein an end of the camera 12 abuts the alignment element 48 of the clamp body 32 such that the lower slot 34 clamps the camera 12 therein.

The method also includes disposing the camera cables 46 extending from the cameras 12 in the side slots 38 of the clamp body 32 (block 64), which extend from the lower slot 34 to exit at one side of the clamp body 32.

The method also includes disposing the deflectable and resilient elongate strip 14 in the upper channel 36 of the fixture body 32 (block 66), wherein an end of the elongate strip 14 abuts the alignment element 48 such that the upper channel 36 clamps the elongate strip 14 in a fixed, upper position relative to the camera 12.

The method also includes applying adhesive between the camera 12 and the sliver 14 (block 68) to mechanically connect the camera 12 with the sliver 14. In some embodiments, the elongate strip 14 includes an aperture 50, and the adhesive is applied through the aperture 50.

The method also includes removing the connected camera 12 and elongated strip 14 from the jig body 32 (block 70), and disposing the connected camera 12 and elongated strip 14, and optionally the light emitting diode 16 and/or irrigation tube 18, in the medical instrument 10 (block 72).

Various features of the invention which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

The embodiments described above are cited by way of example, and the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.