Device for surgery

Abstract

A surgical instrument system (1) for ophthalmic surgery in the interior of an eye, comprising: an OCT device (3) comprising an interferometer; an optical fiber (7) coupled to the OCT device (3) and in which a probe arm of the interferometer extends; a handheld device comprising: - a handpiece (9), - a tube (13) extending from the handpiece (9) and having a distal end portion (15), the distal end portion (15) having a longitudinal axis (14), a distal portion of the optical fiber (7) being disposed within the tube (13); - a beam emitter coupled to a front end (29) of the optical fiber (7) and configured to emit an OCT measuring beam (33) in an emission direction (41) of the beam emitter; and - an actuator configured to change an emission direction (41) of the OCT measuring beam (33) relative to the front end (21) of the distal end region (15); characterized in that a first tangent (T1) to the longitudinal axis (14) at a proximal end (30) of the distal end region (15), and a second tangent (T2) to the longitudinal axis (14) at the front end (21) of the distal end region (15) forms a bending angle (α) of the distal end region (15) which lies in a range between 60° and 100°.

Description

Technical field

[0001] The invention generally relates to a surgical device. More specifically, the invention relates to a device for performing cataract surgery. State of the art

[0002] During cataract surgery, a phacoemulsification needle is inserted into the capsular bag of the patient's eye, passing through the cornea and anterior chamber. Ultrasound energy is applied to the needle to emulsify the patient's natural lens. Emulsified components of the lens are aspirated through the needle, and a viscoelastic fluid is introduced through the needle into the capsular bag. An intraocular lens (IOL) is inserted into the capsular bag after the lens has been removed by this procedure.

[0003] According to another ophthalmic surgical method, a phakic intraocular lens (PIOL) is inserted into the anterior chamber or posterior chamber of the eye without removing the body's own lens.

[0004] To achieve optimal results in a surgery involving the implantation of an intraocular lens into the anterior chamber, posterior chamber, or capsular bag, it is important to select an intraocular lens sized appropriately for the patient's eye. The dimensions of lenses for phakic anterior chamber intraocular lenses and phakic posterior chamber intraocular lenses are usually estimated by adding 0.5 to 1.0 mm to the horizontal white-to-white corneal diameter. However, the white-to-white corneal diameter is not a reliable indicator of the anterior chamber angle-to-angle diameter and the posterior chamber sulcus diameter, also known as the sulcus-to-sulcus distance. In particular, it is difficult to determine the sulcus diameter and capsular bag diameter from outside the eye because optical measurements of the corresponding tissue areas of the eye are inaccessible due to the iris.

[0005] It is therefore desirable to provide a system that allows the measurement of the geometry of ocular tissue.

[0006] US 2003 / 0 004 412 A1 discloses a surgically deployable instrument system for performing OCT measurements inside the body. The system comprises an optical fiber rotating in a tube, at the end of which an OCT measurement beam is emitted.

[0007] US 2009 / 0 093 750 A1 discloses phacoemulsification devices for use in cataract surgery on the human eye. Summary

[0008] With regard to measuring the geometry of ocular tissue, a surgical instrument system having the features of the appended claim 1 is proposed. Advantageous embodiments are specified in the appended subclaims.

[0009] According to the invention, a surgical device is provided for ophthalmic surgery inside the eye, comprising: an OCT device having an interferometer; an optical fiber coupled to the OCT device and in which a probe arm of the interferometer extends; a handset comprising: a handpiece, a tube extending from the handpiece and having a distal end region, the distal end region having a longitudinal axis, a distal portion of the optical fiber being arranged in the tube; a beam emitter coupled to a front end of the optical fiber and configured to emit an OCT measurement beam in an emission direction of the beam emitter;and an actuator configured to change an emission direction of the OCT measurement beam relative to a front end of the distal end region, wherein a first tangent to the longitudinal axis at a proximal end of the distal end portion and a second tangent to the longitudinal axis at the front end of the distal end portion form a bending angle of the distal end portion that is in a range between 60° and 100°, or between 70° and 100°, or between 70° and 95°, or between 80° and 95°, or between 85° and 90°.;

[0010] The handpiece can be configured to be grasped by a user with one or two hands. The handset can also be configured so that the distal end portion can be inserted into the eye through an opening in the cornea. The beam emitter can be arranged within the distal end portion of the tube.

[0011] The distal end region of the tube has a longitudinal axis. The longitudinal axis can be defined as a central axis such that opposite sidewalls of the distal end region of the tube have the same or substantially the same radial distance from the longitudinal axis. A portion of the longitudinal axis can be curved. A diameter of the distal end region can be, for example, between 0.8 mm and 2 mm, or between 0.8 mm and 1.5 mm, or between 0.8 mm and 1.2 mm. A diameter of a core of the optical fiber can be, for example, between 8 and 10 micrometers.

[0012] The core of the optical fiber can be surrounded by a fiber cladding. The core of the optical fiber and the fiber cladding can be arranged within the tube. The outer diameter of the fiber cladding can be between 200 and 400 micrometers, or between 200 and 300 micrometers.

[0013] The beam emitter can be arranged on the longitudinal axis. The beam emitter can be arranged in the distal end region. The beam emitter can be configured such that the emission direction of the emitter is oriented transversely, in particular perpendicularly to a tangent to the longitudinal axis at the position of the beam emitter. The distal end region can be configured such that the OCT measurement beam of the OCT device is emitted by the beam emitter and passes through side walls of the distal region.

[0014] This provides a surgical device that allows the distal end of the tube to be inserted into the eye to be examined. This makes it possible to image the interior of the eye using OCT. Furthermore, it makes it possible to acquire OCT image data without moving the tube. This allows OCT scans to be performed with the tube in a fixed and defined position. The position of the distal end of the tube within the eye can be adjusted by observation with a microscope. The OCT scan can then be performed at the adjusted position.

[0015] According to one embodiment, the distal end region has an axial end portion comprising a transparent tubular portion. The transparent tubular portion is transparent to measurement light of the OCT measurement beam. A length of the transparent tubular portion is within a range of 3 mm to 6 mm, or within a range of 3.5 mm to 5 mm, or within a range of 1 mm to 3 mm, or within a range of 1 mm to 2 mm.

[0016] With a transparent tubular section ranging from 3 mm to 6 mm or from 3.5 mm to 5 mm, it is possible to measure the entire geometry of the capsular bag. A shorter length of the transparent tubular section, ranging from 1 mm to 3 mm or from 1 mm to 2 mm, allows, for example, the imaging of a specific region of the capsular bag, the structure of the chamber angle, or the structure of the ciliary sulcus. A short length of the transparent tubular section has the advantage that the distal section is easier to insert into the interior of the eye and maneuver within the eye.

[0017] The beam emitter may be disposed within the transparent tubular portion. The transparent tubular portion may be defined as a tubular portion that is transparent along its entire length and along its entire circumference. A longitudinal axis of the transparent tubular portion may correspond to the longitudinal axis of the distal end portion. The transparent tubular portion may be configured such that OCT measurement light of the OCT measurement beam can pass from an interior of the tube to an exterior of the tube along the emission direction; from any position on the longitudinal axis within the transparent tubular portion. A portion of the OCT measurement light may be reflected or absorbed in the transparent tubular portion.The transparency of the transparent tubular portion can be such that tissue inside the eye can be imaged with the OCT device when the distal end region is positioned inside the eye. For example, the transparent tubular portion can be made of glass and / or transparent plastic.

[0018] This makes it possible to perform 360° B-scans using the OCT device to image larger tissue areas inside the eye.

[0019] According to a further embodiment, a radius of curvature of the longitudinal axis at any point within the transparent tubular portion is greater than 15 mm, in particular greater than 20 mm, or greater than 30 mm.

[0020] Because the radius of curvature of the longitudinal axis at each point within the transparent tubular section is comparatively large, it is possible to easily reconstruct the structure of the imaged tissue of the interior of the eye without performing time-consuming data correction routines to align individual B-scan planes relative to each other. If the radius of curvature of the longitudinal axis at each point within the transparent tubular section is known, OCT data obtained from the OCT scan can be corrected based on the determined radius of curvature. Furthermore, it is possible to align the longitudinal axis within the transparent tubular section with the main axis of the eye.This makes it possible, for example, to adjust the position of the longitudinal axis within the transparent tubular section so that the transparent tubular section is essentially the same distance from each section of the ciliary sulcus. This makes it possible to measure the structure of the ciliary sulcus with high precision.

[0021] According to one embodiment, the beam emitter is arranged within the transparent tubular portion and the actuator is configured to displace the beam emitter relative to the tube along the longitudinal axis and over the length of the transparent tubular portion.

[0022] This makes it possible to perform B-scans in a variety of planes, with the planes intersecting the longitudinal axis at different positions. This makes it possible, for example, to measure the structure of tissue that extends parallel to the main axis of the eye. Examples of such tissue include the capsular bag, the ciliary sulcus, and / or the chamber angle.

[0023] The bending angle configuration described above makes it possible to insert the distal end of the tube into the interior of the eye at a region of the cornea that is spaced apart from the main axis of the eye. The range of the bending angle allows the position of the region of the cornea where the distal end of the tube is inserted to be optimized. Furthermore, it is possible to adjust the position of the distal end within the eye by observation with a microscope, with the optical axis of the microscope aligned substantially parallel to the main axis of the eye. This makes it possible to precisely align the main axis of the eye with the portion of the longitudinal axis located within the transparent tubular section, so that structures such as the ciliary sulcus, the chamber angle, or the capsular bag are located within the measurement range of the OCT device.Therefore, structures such as the ciliary sulcus, the chamber angle, and the capsular bag can be measured with high precision. Furthermore, since it is possible to insert the distal end region through an opening in the eye that is away from the main axis of the eye, the area of ​​the cornea located close to the main axis is not affected by the opening. Therefore, vision is less likely to be impaired by the opening. Furthermore, since the opening in the cornea is away from the main axis of the eye, the opening can be made large enough to also allow the intraocular lens to be inserted through this opening. Therefore, the surgical instrument system allows the interior of the eye to be imaged using an opening in the cornea through which the intraocular lens is also inserted. Therefore, no additional opening is required.

[0024] According to a further embodiment, a first distance between an intersection point of the first tangent with the second tangent and the proximal end is between 4.5 mm and 8 mm, or between 5 mm and 7 mm, or between 5 mm and 6 mm; and a second distance between the intersection point and the front end is between 5 mm and 9 mm, or between 5 mm and 8 mm, or between 5 mm and 7 mm, or between 3 mm and 6 mm.

[0025] A shorter range of the anterior end distance from the intersection point may be suitable for a shorter transparent tubular section, which is optimized to image tissue regions that have a small extension along the main axis of the eye.

[0026] According to a further embodiment, the handpiece is designed to rotate the distal end region about an axis which is aligned along the first tangent.

[0027] The handpiece can be configured to rotate the distal end region by at least 90° about the axis. The handpiece can have one or more rotary actuators arranged on the tube. The rotary actuators can be controllable, so that the distal end region is rotated upon actuation of the rotary actuators. Furthermore, the surgical instrument system can have a controller that is in signal communication with the rotary actuators and is configured to control the actuation of the rotary actuators. This allows, for example, the user to rotate the tube by actuating a switch button.

[0028] This allows for easy and controlled rotation of the distal end portion when inserting the end portion of the tube into the eye through the opening in the cornea. This allows the distal end portion of the tube to be inserted into the eye without inadvertently causing damage to the intraocular tissue.

[0029] According to one embodiment, a flexural rigidity of the distal end region is such that the distal end region can be inserted into the interior of the eye through an opening in the cornea.

[0030] In particular, the flexural rigidity may be such that the force required to insert the distal end portion through the opening into the cornea is applied by actuating the handpiece.

[0031] According to a further embodiment, the front end of the distal end region is moved by less than 1.5 mm or less than 1 mm or less than 0.5 mm when a force of 0.25 N is applied to the front end and the proximal end is held stationary.

[0032] The force exerted at the anterior end can refer to forces oriented in a direction perpendicular to a tangent of the longitudinal axis at the distal end. However, it is also conceivable that the force refers to forces in any direction. When measuring displacement, the proximal end of the distal end is held stationary, for example, by a clamp.

[0033] This provides a distal end region that has sufficiently high flexural rigidity so that the distal end region can be inserted through an opening in the cornea. Furthermore, the front end moves little or not at all when the optical fiber rotates about the longitudinal axis or is moved along the longitudinal axis. For example, the distal end region can be designed such that the emitter does not move more than 5 micrometers when rotated during a scan. As a result, a distal end region that has high flexural rigidity does not impair the resolution of the OCT image. In particular, tissue structures that are approximately 6.5 mm away from the portion of the longitudinal axis located within the transparent tubular portion can be imaged with high resolution by OCT scans.

[0034] The transparent tubular portion may be made of glass or transparent plastic. The portion of the distal end region between the transparent tubular portion and the proximal end may be made of metal, for example. According to one embodiment, the actuator is configured to rotate the optical fiber about a longitudinal axis of the optical fiber and to move the optical fiber along the longitudinal axis relative to the tube. The OCT measurement is performed by directing the OCT measurement beam from the beam emitter in different directions. The actuator may be configured to rotate the beam emitter at each of a plurality of different positions about the longitudinal axis of the distal end portion at the respective position.An inner diameter of sidewalls of the distal end portion and an outer diameter of a fiber cladding of the OCT device surrounding the optical fiber may be configured to move the beam emitter according to the actuation of the actuator. Within the distal end portion, the longitudinal axis of the fiber may correspond to the longitudinal axis of the distal end portion. The OCT device may be configured to perform an OCT scan at each of the plurality of different axial positions of the beam emitter by rotating the fiber about the longitudinal axis.

[0035] For example, the actuator may be configured to rotate the optical fiber 360° around the longitudinal axis, and the OCT device may be configured to perform a 360° B-scan during the rotation of the fiber. The plurality of B-scans corresponding to the plurality of different axial positions represent an OCT scan of a volume of ocular tissue. The scanned volume may include the ciliary sulcus, the chamber angle, and / or portions of the capsular bag.

[0036] According to exemplary embodiments, the emitter is rotated 360° around an axis to obtain an OCT B-scan of one plane. The beam emitter is then translated in a direction of extension of the distal end region of the tube, and another B-scan is acquired in another adjacent plane. This process is repeated to obtain a sufficient number of B-scans to create an image of a sufficiently large volume of ocular tissue to obtain the desired geometric values ​​of the eye, such as the capsular bag diameter, the sulcus diameter, or the angle-to-angle diameter.

[0037] Additionally or alternatively, the actuator can be configured to simultaneously rotate the fiber around the fiber's longitudinal axis and move the optical fiber axially along the optical fiber's longitudinal axis. This allows the beam emitter to perform a thread-like movement. In other words, the emitter can perform a helical movement around the longitudinal axis. The OCT device can be configured to perform a helical OCT scan during the helical movement of the beam emitter.

[0038] According to exemplary embodiments, the handheld device provides the function of a phacoemulsifier. To this end, the handheld device may include an ultrasound probe for vibrating a front end of the tube or a needle extending adjacent to the tube.

[0039] A method performable with the surgical instrument system includes: inserting an OCT probe into an interior of an eye; emitting an OCT measurement beam from the OCT probe disposed within the eye in a plurality of directions; and receiving OCT measurement light with the OCT probe, wherein the OCT measurement light has been scattered by various tissue structures of the eye.

[0040] The OCT probe is connected to an optical coherence tomography (OCT) device for imaging body tissue. Because the OCT probe is located inside the eye, measurements of ocular tissue can be obtained with high accuracy. In particular, ocular tissue located behind the iris can be imaged, and the sulcus diameter and capsular bag diameter can be precisely determined. Based on such measurements, it is possible to select an intraocular lens from a stock of intraocular lenses that have different sizes. The selected intraocular lens can be inserted into the eye through the same opening in the cornea through which the OCT probe was inserted.

[0041] In this procedure, a hole is created in the natural lens of the eye, and the OCT probe is inserted into this hole to measure the diameter of the capsular bag from within the natural lens. Again, an intraocular lens can be selected from a stock of intraocular lenses that come in various sizes, and the selected intraocular lens can be inserted into the capsular bag after the natural lens has been removed.

[0042] Here, the optical probe is part of a surgical system for ophthalmic surgery inside an eye, comprising: an OCT device having an interferometer; an optical fiber coupled to the OCT device and in which a probe arm of the interferometer extends; a handset comprising: a handpiece, a tube extending from the handpiece and having a distal end, wherein a distal region of the optical fiber is arranged within the tube; a beam emitter coupled to a front end of the optical fiber and configured to emit an OCT measuring beam in an emission direction of the beam emitter; and an actuator configured to change the emission direction of the OCT measuring beam relative to the front end of the tube.

[0043] The surgeon can operate the handheld device by grasping the handpiece with one or two hands to insert the tube into the eye so that the distal end of the tube is positioned appropriately for performing the OCT measurement on the ocular tissue. The OCT measurement is performed by directing the OCT measurement beam from the emitter in different directions.

[0044] According to exemplary embodiments, the handheld device also provides the function of a phacoemulsifier. To this end, the handheld device may include an ultrasound probe for vibrating a leading end of the tube or a needle extending adjacent to the tube. Short description of the drawings

[0045] The above-described, as well as other advantageous features of the invention, should become more apparent from the following detailed description of exemplary embodiments of the invention with reference to the accompanying drawings. Fig. 1 is a schematic representation of a surgical instrument system according to an embodiment of the invention; Fig. Figure 2A is a schematic representation of a distal end portion of the tube of the surgical instrument system used in the Fig. 1 is shown; Fig. Figure 2B is a schematic representation of the distal end portion of the surgical instrument system used in the Fig. 1 is shown; Fig. Figure 2C is a schematic representation of the process of inserting the distal end portion of the tube of the surgical instrument system, which is used in the Fig. 1 is shown; Fig. Figure 2D is a schematic representation of the process of inserting the distal end portion of the tube of the surgical instrument system, which is used in the Fig. 1 is shown; Fig. 3 is an illustration of a method for performing an OCT measurement on an anterior chamber of an eye; Fig. 4 is an illustration of a method for performing an OCT measurement on a posterior chamber of an eye; and Fig. 5 is an illustration of a method for performing an OCT measurement of a capsular bag of an eye. Description of exemplary embodiments

[0046] Fig. 1 is a schematic representation of a surgical instrument system 1 according to an embodiment. The surgical instrument system 1 comprises an optical coherence tomography (OCT) device having an optical interferometer housed in a housing 5 (not shown in detail in the Fig. 1). The interferometer comprises a reference arm and a probe arm. The probe arm is provided and arranged in an optical fiber 7. The optical fiber 7 has a fiber core (not illustrated in the Fig. 1) to transmit OCT measurement light from the OCT device 3. The fiber 7 extends through a handpiece 9 of the handheld device. The handheld device is operated by the surgeon. The handheld device has a tube 13 extending from the handpiece 9, with the optical fiber 7 disposed within the tube 13 and extending through the tube 13 toward a distal end region 15 of the tube 13.

[0047] Fig. Figure 2A is a more detailed cross-section of the distal end portion 15 of the tube 13. The distal end portion 15 has a longitudinal axis 14. The longitudinal axis 14 is curved. The distal end portion 15 has a curved axial section 12 extending over a length L. The length L can be in a range between 2 mm and 8 mm, in a range between 2 mm and 6 mm, or in a range between 2 mm and 5 mm, or in a range between 2 mm and 3 mm.

[0048] At any point on the longitudinal axis 14 within the curved axial section 12, the radius of curvature of the longitudinal axis 14 is within a range of 1 mm to 6 mm, or within a range of 2 mm to 5 mm, or within a range of 1 mm to 3 mm, or within a range of 1 mm to 2 mm. The radius of curvature may be constant within the curved axial section 12, or the radius of curvature may vary within the curved axial section 12.

[0049] The distal end portion 15 further includes an axial end portion 10 disposed distal to the curved end portion. The axial end portion 10 may be in contact with the curved axial portion 12.

[0050] A length of the axial end portion 10 may be between 2 mm and 7 mm, or between 5 mm and 7 mm, or between 3 mm and 6 mm, or between 3 mm and 4 mm.

[0051] The distal end portion 15 further includes a proximal axial section 34 disposed proximal to the curved axial section 12. The proximal axial section 34 may be in contact with the curved axial section 12. A proximal end of the proximal axial section is the proximal end 30 of the distal end portion 15. The proximal end 30 may be defined as a location disposed at the opening of the cornea when the distal end portion has been inserted into the eye.

[0052] At any point on the longitudinal axis 14 within the proximal end portion 34, the radius of curvature of the longitudinal axis may be greater than 15 mm, in particular greater than 20 mm, or greater than 30 mm.

[0053] A length of the proximal axial section 34 may be between 3 mm and 6 mm, or between 4 mm and 5.5 mm.

[0054] The inner sidewalls 26 of the axial end section 10 are oriented parallel to the longitudinal axis 14 within the distal end section 10. Furthermore, an outer diameter of the optical fiber 7 and an inner diameter of an inner sidewall are adapted such that the inner sidewalls serve as a guide for the optical fiber. As a result, a mirror prism 37, which is attached to the optical fiber 7 via a GRIN lens 31, is arranged at a well-defined position during the scanning process.

[0055] Therefore, in the case where multiple B-scans are performed at multiple axial positions, the scan planes are oriented substantially parallel to each other. In other words, the scan planes deviate only slightly from an optimal parallel orientation. This allows precise measurements of internal structures of the eye to be obtained. The distal end portion 15 can be made of metal and / or plastic. This allows the tube to have a suitable rigidity to maintain its shape during use. For example, a flexural rigidity of the distal end portion 15 of the tube 13 can be such that the distal end portion 15 can be inserted into the eye through an opening in the cornea of ​​the eye. The front end 21 of the tube 13 can be sharpened so that the front end 21 can be used to form the opening in the cornea. For example, the front end 21 can have a knife portion or a sharp edge 105.

[0056] The distal end region 10 has a transparent tubular portion 23. The transparent tubular portion 23 can be made of glass and / or transparent plastic. The transparent tubular portion 23 is transparent over its entire circumference and along its entire length L1 of the transparent tubular portion 23.

[0057] Therefore, OCT measurement light of the OCT measurement beam is transmittable through the transparent tubular portion 23 from the inside of the tube 13 to the outside of the tube 13. Furthermore, it is possible to perform OCT scans at any point along the longitudinal axis within the transparent tubular portion 23.

[0058] A fiber core 25 and a fiber cladding 27 of the fiber 7 extend through the distal end portion 15 of the tube 13 toward the end of the distal end portion 15. A front end 29 of the fiber is coupled to a gradient index lens 31 (GRIN), which expands OCT measurement light supplied through the fiber 7 from the OCT device 3 to form a measurement beam 23 emitted from a front end 35 of the GRIN lens 31. A mirror prism 37 is attached to the front end 35 of the GRIN lens 31 and reflects the measurement light so that it is emitted in a direction 41 that extends transversely to an extension direction 42 of the distal end portion of the tube. An angle between directions 41 and 42 may be 90° or greater, such as 100° or 120°, or smaller, such as 80° or 70°.

[0059] The GRIN lens 31 is configured to form a beam waist 45 of the OCT measurement beam 33 at a distance d of approximately 6 mm from a position of the mirror prism 37 on the longitudinal axis 14 of the tube 13. Other exemplary values ​​of the distance d are approximately 4 mm, approximately 7 mm, and approximately 9 mm. It is also possible for the beam 33 emitted by the GRIN lens 31 to be a collimated parallel beam.

[0060] As in Fig. 1, the OCT device 3 comprises an actuator, such as a pair of rollers 51, which is driven by a motor to rotate the fiber 7 about the longitudinal axis of the distal end portion 15. In Fig. 2 this is shown by an arrow 47. As a result, the GRIN lens 31 and the prism 37 rotate around an axis oriented in the direction 42, as shown by an arrow 49 in the Fig. 2. The actuator for rotating the fiber 7 can be arranged in the housing 5 or in the handpiece 9. Background information regarding OCT devices having a rotating fiber can be obtained from document US 6,134,003, the disclosure of which is also incorporated herein by reference in its entirety.

[0061] Due to the rotation of the beam emitter formed by the GRIN lens 31 and the prism 31, the OCT measuring beam 33 also rotates around the longitudinal axis of the tube 13 at the position of the mirror prism 37. While the fiber 7 rotates 360°, the OCT device records an OCT B-scan.

[0062] The handset 11 includes an actuator such as a pair of rollers 51 driven by a motor controlled by the OCT device 3 to displace the fiber 7 within the tube 13 along a longitudinal direction of the tube 13. Fig. Figure 2 shows an OCT measuring beam 33' in dashed lines, which is emitted by the reflection prism 37 when the actuator 51 moves the fiber 7 by a length f of, for example, 3 mm relative to the position shown in solid lines in the Fig. 2 is shown, has withdrawn.

[0063] By rotating the fiber 7 around its longitudinal axis and translating the fiber 7 along its longitudinal direction, the OCT device 3 can systematically scan a volume around the front end 21 of the tube 13 and perform an OCT image of this volume. The rotation and translation of the fiber can be performed at constant speeds, so that, based on measurement times, measurement data can be assigned to coordinates of tissue structures. However, it is also possible to allow known, non-constant rotation speeds and known non-constant speeds of longitudinal movement if the data analysis takes these speeds into account.

[0064] Scanning can be stopped by the surgeon by pressing a button 57 (shown in the Fig. 1), which is arranged on a front panel of the housing 5. A representation of the acquired OCT image of the OCT scan can be displayed, for example, on a monitor 59. Furthermore, the surgeon can identify certain features in the image and perform measurements, such as distance measurements, for example, using a mouse 61 or a keyboard 63 to move a crosshair cursor or pointer between areas of the image and features within the image and to calculate distances between different features in the image.

[0065] Fig. 2B shows a schematic representation of the distal end portion 15 of the tube 13 in a measuring position within an eye 73. The distal end portion 15 has been inserted into the human eye through an opening 78 in the cornea 75. A first tangent T1 is a tangent to the longitudinal axis at a proximal end 30 of the distal end portion 15. A second tangent T2 is a tangent to the longitudinal axis at a distal end TP of the distal end portion 15. A bending angle α of the second tangent T2 relative to the first tangent T1 is between 60° and 100°, or between 70° and 100°, or between 70° and 95°, or between 80° and 95°, or between 85° and 90°.

[0066] The bending angle α is measured to be 0 in the case where the first tangent and the second tangent are parallel. Depending on the curvature of the longitudinal axis, the first tangent T1 and the second tangent T2 may not intersect. In this case, the bending angle α is calculated by projecting the first tangent T1 and the second tangent T2 onto a plane (not shown) parallel to the first tangent T1 and the second tangent T2. The bending angle α is then determined from the projected tangents.

[0067] A distance of a proximal end 30 of the distal end region 15 from an intersection point IP of the first tangent T1 and the second tangent T2 is between 4.5 mm and 8 mm, or between 5 mm and 7 mm, or between 5 mm and 6 mm. Furthermore, a distance between the intersection point IP and the front end 21 is between 5 mm and 8 mm, or between 5 mm and 7 mm, or between 3 mm and 6 mm.

[0068] In case the first tangent T1 does not intersect with the second tangent T2, the intersection point IP for each of the tangents T1 and T2 can be determined by projecting each of these tangents T1 and T2 onto the plane oriented parallel to each of these tangents and by determining the point on the first tangent T1 and the second tangent T2, respectively, which is located closest to the projected intersection point.

[0069] As in the Fig. 2B, it is therefore possible to arrange the distal end portion 15 of the tube 13 within the eye 73 such that the longitudinal axis 14 within the axial end section 10 is aligned with the main axis 91 of the human eye 73. Furthermore, it is possible to insert the distal end portion 15 through an opening 78 located away from the main axis 91 of the eye 73. Thereby, the adjustment of the position and orientation of the axial end section 10 is observable through a microscope, wherein an optical axis of the microscope is substantially parallel to the main axis 91 of the eye 73. Thereby, the adjustment of the position and orientation of the axial end section 10 can be performed with high accuracy. Furthermore, since the opening 78 is located away from the main axis 91 of the eye 73, the region of the cornea 75 that is close to the main axis 91 is not affected by the opening 78.Therefore, aperture 78 is less likely to impair vision.

[0070] As in the Fig. 2B, the transparent tubular portion 23 of the distal end portion 15 further allows imaging of the chamber angle 83 and the ciliary sulcus 81 of the eye 73 with angular scans over 360°. Since the longitudinal axis within the axial end portion 10 of the distal end portion 15 is aligned with the main axis 91 of the eye 73, it is possible to obtain OCT data of the structure of the chamber angle 83, the ciliary sulcus 81, and / or the capsular bag 85 along their entire circumference. This makes it possible, for example, to select an intraocular lens or to manufacture an intraocular lens that best fits the eye 73.

[0071] The Fig. 2C and Fig. 2D illustrate the process of inserting the distal end portion 15 through the opening 78 in the cornea 75 of the eye 73. Fig. 2C and Fig. 2D show the eye 73, seen for example through a microscope, which is used to align the axial end portion 10 to the main axis 91 of the eye 73. In the Fig. 2C and Fig. In 2D, the main axis 91 of the eye is oriented perpendicular to the plane of the drawing.

[0072] As in the Fig. 2C, the distal end portion 15 is inserted through the opening 78 in the cornea 45 by moving the axial end section 10 along an insertion direction indicated by the arrow 99. After the distal end portion 15 has been partially inserted, the distal end portion 15 is rotated about a tangent to the longitudinal axis at the proximal end 30 of the distal end portion 15. After or simultaneously with the rotation, the distal end portion 15 is further inserted into the eye 73 until the proximal end 30 is disposed at the opening 78. Thereby, the axial end portion 10 of the distal end portion 15 is guided through the pupil 97 of the eye 73 and the distal end portion 15 is positionable at the measurement position, as in the Fig. 2D. The position of the distal end region 15 within the eye 73, as shown in Fig. 2D corresponds to the position shown in the Fig. 2B.

[0073] An embodiment of an OCT method which can be performed using the surgical instrument system 1 is shown in the Fig. 3. Fig. 3 shows an anterior region 71 of a human eye 73, which has a cornea 75, a limbus 77, an iris 79, an anterior chamber 89, a chamber angle 81, a posterior chamber 82, a sulcus 83, a capsular bag 85, including a natural lens 87. The distal end region 15 of the tube 73 of the handset 11 is inserted through an opening in the cornea such that the front end 21 of the tube 13 and the beam emitters 31, 35 are disposed within the anterior chamber 89 of the eye 73. In particular, the distal end of the tube 13 is positioned near a major axis 91 of the eye 73 and oriented such that the direction 42 is substantially parallel to the major axis 91. With the handset 11 in such a position, an OCT volume scan is performed, as illustrated above. The volume scan covers various tissue parts of the eye 73, in particular the chamber angle 81.A chamber angle-to-chamber angle diameter 83 can be determined by the surgeon through interpretation and analysis of the acquired OCT images displayed on monitor 59. Based on this determination of the chamber angle-to-chamber angle diameter, the surgeon can select a suitable phakic intraocular lens from a pool of lenses having different diameters. The selected lens can be inserted into the anterior chamber through the same opening through which the tube 13 was previously inserted.

[0074] Fig. Figure 4 illustrates another embodiment of the method. The method described in Fig. 4 is similar to the process described by Fig. 3. However, the front end 21 of the tube 13 is inserted into the anterior chamber 82 of the eye 73 in such a way that it is positioned closer to the natural lens 87, so that the beam 33 emitted from the distal end 21 of the tube 13 reaches the sulcus 81. For this purpose, it may be necessary to push the natural lens slightly downwards, as shown in the Fig. 4. By performing a volume scan with such positioning of the anterior end of the tube 13, it is possible to image relevant regions of the sulcus 81 to determine the sulcus diameter, also referred to as the sulcus-to-sulcus diameter. Again, the surgeon can select a phakic intraocular lens of appropriate size from a pool of lenses that have different sizes. The selected lens can be inserted into the anterior chamber through the same opening through which the tube was inserted.

[0075] Fig. Figure 5 illustrates another embodiment of an OCT measurement. In this embodiment, the front end 21 of the tube 13 is positioned within the body's own lens 87 after an opening or hole 95 has been formed in the lens 87 by a suitable method, such as phacoemulsification. The tube 13 is positioned such that the end substantially coincides with an axis 91 of the lens and is oriented substantially parallel thereto. An OCT volume scan with such a configuration of the tube 13 acquires an image of the capsular bag from which the surgeon can determine the diameter of the capsular bag 85 to select a suitable intraocular lens from a pool of lenses having different diameters.

[0076] The tube 73 can be withdrawn from the eye, and the autologous lens 87 can be removed, for example, by phacoemulsification. The surgeon can then insert the appropriate intraocular lens into the capsular bag 85 through the same opening through which the tube 13 was previously inserted. The actuator 51 can be controlled such that the fiber 7 is withdrawn from the interior of the tube 13 to a sufficient extent. For example, such withdrawal can position the front end of the fiber 7 within the handpiece 9. This process can be controlled by a button 101 located on the front panel of the housing 5, or by another input device, such as a keyboard 63 or a mouse 61.

[0077] After such retraction of the fiber from the tube, the handpiece 11 can be operated as a phacoemulsifier. For this purpose, the handpiece comprises an ultrasound head 103 coupled to the tube 13, causing the front end of the tube to vibrate at a high frequency. The front end 21 of the tube carries a knife portion or sharp edge 105 configured to cut away body tissue, such as the body's own lens.

[0078] The surgical instrument system further comprises a supply system 107 of a viscoelastic fluid, which is pumped into the tube 13 via a connecting tube 109. Furthermore, the system 1 comprises a suction device 111, which is connected to the tube 13 via a connecting tube 113. A foot switch 115, which can be moved in a direction indicated by an arrow 117 in the Fig. 1, or another input device, can be used by the surgeon to operate the ultrasound transducer 103, the fluid supply 107, and the suction device 101 to perform phacoemulsification. As shown in the Fig. For example, as shown in Figure 5, the hole 95 can be formed in the body's own lens 87 using the handset 11, which can then be used to perform the OCT scan.

[0079] While certain exemplary embodiments are disclosed herein, alternatives, modifications, and variations will be apparent to one skilled in the art. Therefore, the exemplary embodiments set forth herein are intended to be illustrative and not restrictive. Various changes may be made without departing from the scope or spirit of the present disclosure.

Claims

[1] A surgical instrument system (1) for ophthalmic surgery in the interior of an eye, comprising: an OCT device (3) comprising an interferometer; an optical fiber (7) coupled to the OCT device (3) and in which a probe arm of the interferometer extends; a handheld device comprising: - a handpiece (9), - a tube (13) extending from the handpiece (9) and having a distal end portion (15), the distal end portion (15) having a longitudinal axis (14), a distal portion of the optical fiber (7) being disposed within the tube (13); - a beam emitter coupled to a front end (29) of the optical fiber (7) and configured to emit an OCT measuring beam (33) in an emission direction (41) of the beam emitter; and - an actuator configured to change an emission direction (41) of the OCT measuring beam (33) relative to the front end (21) of the distal end region (15); characterized by that a first tangent (T1) to the longitudinal axis (14) at a proximal end (30) of the distal end region (15), and a second tangent (T2) to the longitudinal axis (14) at the front end (21) of the distal end region (15) forms a bending angle (α) of the distal end region (15) which lies in a range between 60° and 100°. [2] The surgical instrument system (1) according to claim 1, wherein the distal end portion (15) has an axial end portion (10), wherein the axial end portion (10) has a transparent tubular portion (23) which is transparent to measuring light of the OCT measuring beam (33), wherein a length (L1) of the transparent tubular portion (23) is within a range between 3 mm and 6 mm, or within a range between 3.5 mm and 5 mm, or within a range between 1 mm and 3 mm, or within a range between 1 mm and 2 mm. [3] The surgical instrument system (1) according to claim 2, wherein a radius of curvature of the longitudinal axis (14) at any point within the transparent tubular portion (23) is greater than 15 mm, or greater than 20 mm, or greater than 30 mm. [4] The surgical instrument system (1) according to claim 2 or 3, wherein the beam emitter is arranged within the transparent tubular portion (23), and wherein the actuator is configured to displace the emitter relative to the tube (13) along the longitudinal axis (14) and over the length (L1) of the transparent tubular portion (23). [5] The surgical instrument system (1) according to one of claims 1 to 4, wherein a first distance between an intersection point (IP) of the first tangent (T1) with the second tangent (T2) and the proximal end (30) is between 4.5 mm and 8 mm, or between 5 mm and 7 mm, or between 5 mm and 6 mm; and wherein a second distance between the intersection point (IP) and the front end (21) is between 5 mm and 9 mm, or between 5 mm and 8 mm, or between 5 mm and 7 mm, or between 3 mm and 6 mm. [6] The surgical instrument system (1) according to one of claims 1 to 5, wherein the handset (9) is configured to rotate the distal end portion (15) about an axis aligned with the first tangent (T1). [7] The surgical instrument system (1) according to one of claims 1 to 6, wherein a flexural rigidity of the distal end portion (15) is such that the distal end portion (15) is insertable into the interior of the eye (73) through an opening (78) in a cornea (75) of the eye (73). [8] The surgical instrument system (1) according to one of claims 1 to 7, wherein the front end (21) of the distal end portion (15) is displaced by less than 1.5 mm, in particular less than 1 mm, when a force of 0.25 N is exerted on the front end (21), the proximal end (30) being held stationary. [9] The surgical instrument system (1) according to any one of claims 1 to 8, wherein the actuator is configured to rotate the optical fiber (7) about the longitudinal axis (14). [10] The surgical instrument system (1) according to any one of claims 1 to 9, wherein the actuator is configured to rotate the optical fiber (7) about the longitudinal axis and to move the optical fiber (7) along the longitudinal axis (14) relative to the tube (14). [11] The surgical instrument system (1) according to any one of claims 1 to 10, wherein the beam emitter comprises a GRIN lens. [12] The surgical instrument system (1) according to one of claims 1 to 11, wherein the beam emitter comprises a reflector (37). [13] The surgical instrument system (1) according to one of claims 1 to 12, wherein the beam emitter is configured to shape the OCT measuring beam (33) such that the OCT measuring beam (33) has a beam tail (45) at a distance (d) between 4 mm and 9 mm, or between 4 mm and 6 mm from the position of the beam emitter. [14] The surgical instrument system (1) according to any one of claims 1 to 13, wherein the optical fiber (7) is retractable from the tube (13). [15] The surgical instrument system (1) according to one of claims 1 to 14, wherein the handheld device comprises a phacoemulsifier. [16] The surgical instrument system (1) according to claim 15, wherein the phacoemulsifier comprises a hollow needle extending adjacent to the tube (15). [17] The surgical instrument system (1) according to claim 15 or 16, wherein the phacoemulsifier comprises an ultrasonic head configured to vibrate a front end of the hollow needle. [18] The surgical instrument system (1) according to claim 16 or 17, wherein the hand-held device comprises a sheath, the tube and the hollow needle being arranged within the sheath. [19] The surgical instrument system (1) according to any one of claims 15 to 18, wherein the phacoemulsifier comprises an ultrasonic head (103) configured to vibrate the front end (21) of the tube (15) or the front end of the hollow needle. [20] The surgical instrument system (1) according to claim 19, wherein the front end (21) comprises a needle. [21] The surgical instrument system (1) according to any one of claims 15 to 20, wherein the phacoemulsifier has a liquid supply (107). [22] The surgical instrument system (1) according to any one of claims 15 to 21, wherein the phacoemulsifier comprises a suction line (113).

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