One-piece patient interface device for ophthalmic laser surgery

Abstract

A one-piece patient interface device for coupling an eye of a patient to an ophthalmic surgical laser system includes a tapered base having a rigid frustoconical housing for coupling to the laser system, and a flexible suction ring integrally joined to a lower end of the rigid housing for coupling to the eye of the patient. The suction ring has a circular skirt extending downwardly from a base portion, a septum extending from the base portion and disposed within the skirt, and a contact lens held by the septum to cover the central opening. When the skirt contacts a surface of the eye, the skirt, the septum, the contact lens, and the eye surface form a vacuum chamber where a vacuum may be applied to secure the patient interface device to the eye. The parameters of the suction ring are optimized to fit a wide range of eye sizes, including smaller eyes.

Description

[0001] Cross-references to related applications This application claims priority to U.S. Patent Application No. 63 / 583,455, filed September 18, 2023, the entire contents of which are incorporated herein by reference in their entirety. Background Technology

[0002] This invention relates to laser systems for ophthalmic surgery, and more specifically, to a patient interface device for stabilizing a patient's eye and delivering a laser beam to the eye during ophthalmic surgery.

[0003] Laser-assisted eye surgery is a common procedure for vision correction, cataract treatment, and more. During such procedures, a series of laser pulses are precisely delivered to the cornea, lens, or other tissues of the eye to create incisions via optical anatomy. Prior to this type of surgery, the patient's eye must be connected to the laser system and remain stationary during laser treatment to eliminate any opportunity for eye movement. Any eye rotation or displacement may cause the surgeon to terminate the procedure or result in postoperative complications such as delayed recovery of visual acuity, visual aberrations, and coma.

[0004] In some current ophthalmic surgical laser systems, the laser instrument and the patient's eye are connected via a two-piece patient interface device, which includes a lens barrel that holds a contact lens and a suction ring with a flexible skirt. During the eye docking procedure prior to the start of laser treatment, the suction ring is coupled to the eye by applying a vacuum to it, the lens barrel is coupled to the laser delivery head of the laser system, and the two components are assembled and locked together. Some examples of two-piece patient interface devices are described in co-owned U.S. Patent Application No. 17 / 663,198, filed May 12, 2022, and co-owned U.S. Patent Application No. 18 / 054,915, filed November 14, 2022. While two-piece patient interface devices have their advantages, the assembly of the two components during the docking procedure is time-consuming, and in some cases, the two components can still undergo some degree of relative movement, resulting in movement of the eye relative to the laser system.

[0005] Some other ophthalmic surgical laser systems employ a single piece patient interface device in which a single piece structure is coupled to both the eye and the laser system. Some examples of single piece patient interface devices are described in commonly owned U.S. Patent Application Publication No. 20170281407 entitled “Patient interface device for laser eye surgery having light guiding structure for illuminating eye,” commonly owned U.S. Patent Application Publication No. 20180116870 entitled “Patient interface device for ophthalmic surgical laser system,” and U.S. Patent Application Publication No. 20180303664 entitled “Patient interface device for ophthalmic surgical laser system.” Single piece patient interface devices can improve workflow, reduce procedure time, reduce the number of components required for surgery, reduce the opportunity for eye movement, and improve ease of use.

[0006] Patient interface devices having scleral support features are described, for example, in commonly owned U.S. Patent Application Publication No. 20230149217 entitled “Patient interface for ophthalmic laser surgery employing scleral support structures to reduce intraocular pressure.” SUMMARY

[0007] Embodiments of the present invention provide a single piece patient interface device that is optimized to fit a wide range of eye sizes, including smaller eyes, while reducing undesirable effects during interfacing.

[0008] Additional features and advantages of the invention will be set forth in the description that follows, and in part will be apparent from the description, or can be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the structure particularly pointed out in the written description and claims thereof as well as the appended drawings.

[0009] To achieve the above objectives, the present invention provides a patient interface device for coupling a patient's eye to an ophthalmic surgical laser system. The patient interface device includes: a tapered base comprising a rigid truncated conical housing configured for coupling to the ophthalmic surgical laser system; and a flexible suction ring connected to a lower end of the rigid housing. The tapered base and suction ring are integrally formed as a single piece. The suction ring includes a base portion connected to the lower end of the rigid housing, a circular skirt extending downward from the base portion, a circular diaphragm extending from the base portion and disposed within the skirt, and a contact lens connected to the diaphragm and disposed in a central opening of the diaphragm. When the skirt contacts the surface of the patient's eye, the skirt, diaphragm, contact lens, and the surface of the eye form a vacuum chamber.

[0010] In some embodiments, the outer diameter of the skirt is between 14 mm and 21 mm, the skirt length is defined as the vertical distance from the lower surface of the contact lens to the distal end of the skirt being between 3 mm and 6.5 mm, the skirt thickness is between 0.25 mm and 3 mm, and the skirt stiffness is between 20 A and 70 A Shore hardness. In some embodiments, the outer diameter of the skirt is between 15 mm and 19 mm, the skirt length is between 5.47 mm and 5.52 mm, the skirt thickness is between 0.42 mm and 0.62 mm, and the skirt stiffness is between 30 A and 42 A Shore hardness. In a particular example, the outer diameter of the skirt is 19 mm, the skirt length is 5.5 mm, and the skirt thickness is 0.5 mm.

[0011] In some embodiments, the skirt is vertical; in other embodiments, the skirt has a flare of 5 to 8 degrees. In some embodiments, the suction ring also includes a plurality of scleral support pads connected to the diaphragm and extending downward and evenly spaced in the circumferential direction, wherein the bottom surface of each scleral support pad is inclined, lower at the radially outer end and higher at the radially inner end.

[0012] It should be understood that the foregoing general description and the following detailed description are merely exemplary and illustrative, and are intended to provide further explanation of the claimed invention. Attached Figure Description

[0013] Figure 1 This is a top perspective view of a one-piece patient interface device according to an embodiment of the present invention.

[0014] Figure 2 for Figure 1 Bottom plan view of the patient interface device.

[0015] Figure 3 for Figure 1Bottom perspective view of a suction ring of a patient interface device.

[0016] Figure 4 For Figure 1 Side cutaway view and cross-sectional view of a suction ring of a patient interface device.

[0017] Figure 5 Illustrates a portion of a suction ring of a patient interface device that is secured to an eye of a patient. Figure 1

[0018] Figure 6A Cutaway view to schematically illustrate a portion of a suction ring of a patient interface device according to one embodiment of the present application.

[0019] Figure 6B Cutaway view to schematically illustrate a portion of a suction ring of a patient interface device that holds a contact lens against an eye. Figure 6A

[0020] Cutaway view to schematically illustrate a portion of a suction ring of a patient interface device according to another embodiment of the present application. Figure 7A

[0021] Cutaway view to schematically illustrate a portion of a suction ring of a patient interface device that holds a contact lens against an eye. Figure 7B Figure 7A Cutaway view to schematically illustrate a portion of a patient interface device of

[0022] Figures 8A to 8E Figure 1 Schematically illustrates a portion of a patient interface device of Figure 8A Patient interface device with a model of an eye of normal size, with no flattening of the cornea. Figure 8B Patient interface device with a model of an eye of normal size, with some flattening of the cornea, such that a seal with the surface of the eye is formed prior to application of vacuum suction. Figure 8C Patient interface device with a model of an eye of smaller size, with no flattening of the cornea. Figure 8D Patient interface device with a model of an eye of smaller size, with some flattening of the cornea, such that a seal with the surface of the eye is formed prior to application of vacuum suction. Figure 8E Patient interface device with a model of an eye of larger size, with no flattening of the cornea, and a seal with the surface of the eye is formed prior to application of vacuum suction. DETAILED DESCRIPTION

[0023] Reference is made to Figures 1 to 5 describing a one-piece patient interface device according to an embodiment of the present application. Figure 1 ​​​This is a perspective view of the patient interface device 10, and Figure 2 This is its bottom plan view. The patient interface device 10 is a one-piece structure comprising an integrally formed conical base 16 and a suction ring 11. The conical base 16 includes a rigid truncated conical housing 12 defining a larger upper opening 12a and a smaller lower opening; the suction ring 11 is attached to the lower end of the rigid housing. The conical base 16 also includes a tubular guide arm 13 extending from the housing 12. The conical base 16 is preferably formed of a rigid plastic material (such as polycarbonate) or other suitable material. The suction ring 11 is preferably formed of a soft, flexible material (such as soft thermoplastic elastomer (TPE) material) or other suitable flexible and compliant material (such as silicone, flexible plastic, rubber, etc.). The suction ring 11 and the conical base 16 are preferably integrally connected by overmolding, which eliminates the need for adhesives, but they may alternatively be connected by adhesives or other means. The patient interface device is a one-piece device because its components are not intended to be separated during normal use.

[0024] Figure 3 yes Figure 1 Bottom perspective view of the suction ring 11 of the patient interface device (relative to) Figure 1 (inverted orientation), and Figure 4 This is a side sectional view of the suction ring. Note that, for clarity, these figures show the suction ring 11 itself, but as previously described, the suction ring 11 is integrally connected to the tapered base 16. Figure 2 , Figure 3 and Figure 4 As shown, the suction ring 11 includes a base portion 24 connected to the lower end of the housing 12, and a flexible skirt 21 and a flexible diaphragm 22 extending from the base portion. Both the skirt and the diaphragm are circular. The skirt 21 extends substantially vertically and downward from the base portion 24. The diaphragm 22 is disposed inside the skirt and is recessed relative to the distal (lower) end 21a of the skirt 21.

[0025] In the illustrated embodiment, the proximal (upper) portion of the diaphragm 22 extends downward and is spaced apart from the skirt by an annular gap; the distal portion 22b of the diaphragm 22 is radially inwardly curved to form a flange, wherein the inner circumference of the flange is adapted to retain the contact lens 17 of the patient interface device in the central opening 17a of the diaphragm. More specifically (see...) Figure 8AThe contact lens 17, preferably made of glass, is disc-shaped and has a groove around its circumferential side surface. The distal end 22a of the diaphragm, i.e., the inner periphery of the flange, fits into the groove to hold the contact lens 17. The cross-sectional shapes of the groove and the distal end 22a of the diaphragm are complementary to each other to firmly hold the contact lens. When the patient interface device is coupled to the laser delivery head, the lower end 31 of the laser delivery head (e.g., an objective lens) passes through the housing 12 and contacts the top surface of the contact lens 17 (see [link to documentation]). Figure 8A When the patient interface device is coupled to the patient's eye, the laser delivery head 31 pushes the contact lens 17 against the cornea to flatten it (see...). Figure 8B The lower surface of the contact lens that contacts the cornea can be flat or curved (e.g., concave). The shape of the septum 22 is not limited to... Figure 4 and Figure 8A The shape shown; other shapes may also be used, as long as the diaphragm securely holds the contact lens 17 in the desired position.

[0026] exist Figures 2 to 4 In the illustrated embodiment, the suction ring 11 further includes a plurality of discrete scleral support pads 23 located inside the skirt 21, which are incorporated into and extend downward therefrom the curved portion 22b of the diaphragm 22. The scleral support pads 23 are preferably spaced evenly in the circumferential direction. The bottom surface of each scleral support pad 23 is inclined, lower at the radially outer end (closer to the lower edge of the skirt 21), and higher at the radially inner end. The scleral support pads are optional.

[0027] The suction ring 11 of the patient interface also defines a vacuum port 18, which opens on the inner surface of the skirt 21. The other end of the vacuum port is connected to a suction tube 14, which extends along the tube guide arm 13 and ultimately connects to a vacuum source.

[0028] When the patient interface device is placed on the patient's eye and the skirt 21 contacts the surface of the eye, the skirt, diaphragm, contact lens 17, and eye surface form a vacuum chamber (see...). Figure 8B The vacuum chamber is sealed except for the vacuum port 18. By applying vacuum pressure to the vacuum chamber via the vacuum port 18 and the suction tube 14, the suction ring 11 can be securely coupled to the patient's eye (see [link to article]). Figure 5 ). Figure 6B (A cross-sectional view of the suction ring, contact lens, and a portion of the eye) illustrates the relationship with... Figure 6AThe image shows the deformation shape of the suction ring under vacuum pressure, compared to its undeformed state. It can be seen that when the contact lens flattens the cornea and vacuum pressure is applied, the skirt 21 bends inward under vacuum force, and most of the lower part of the skirt contacts and extends along the eye surface, thus forming a tight vacuum seal. When vacuum pressure is applied, the lower end of the scleral support pad 23 also contacts the eye surface. Figure 7A and Figure 7B Is with Figure 6A and Figure 6B A similar view, but for a suction ring without any scleral support pad. Note that in either case, when vacuum pressure is applied, the diaphragm 22 (excluding the scleral support pad) does not contact the surface of the eye, but the upper portion of the diaphragm 22 may deform due to being pushed inward by the skirt 21.

[0029] During the ophthalmological procedure prior to laser treatment, in order to couple the eye to the laser delivery head, the patient interface device 10 is first installed on the laser delivery head, for example by using multiple bayonet slots 15 on the housing 12 (see...). Figure 1 The patient interface is connected to a corresponding protruding pin (not shown) on the laser delivery head. The patient and laser delivery head are brought closer together (e.g., by moving the laser delivery head and / or the patient bed) until the suction ring 11 of the patient interface device, particularly the distal end of the skirt 21, contacts the patient's eye. A vacuum is then applied to the suction ring via the suction tubing 14 to secure the patient interface to the eye.

[0030] A challenge in patient interface design is ensuring the device fits different eye sizes. A typical or "normal-sized" human eye has a diameter of approximately 24mm, but smaller eyes can be as small as 21mm, while larger eyes can be as large as 27mm. The same patient interface device will fit differently when used with different eye sizes, such as… Figures 8A to 8E exemplified.

[0031] Figures 8A to 8E A patient interface device is schematically illustrated, which is coupled to a laser delivery head such that the lower end of the laser delivery head 31 abuts against a contact lens 17 in various spatial relationships relative to various eye models. No vacuum suction is applied. Figure 8A A suction ring is shown placed on a model of a normal-sized eye (24 mm in diameter). Without flattening the cornea (i.e., the contact lens 17 only touches the top of the cornea but does not flatten it), the lower end 21a of the skirt 21 cannot reach the surface of the eye. For the illustrated suction ring model, the gap between the lower end 21a of the skirt and the surface of the eye is 0.458 mm. Figure 8BThe same suction ring with the same eye model is shown, but before the lower end 21a can touch the eye surface to form a seal, the cornea is slightly flattened by the contact lens 17 (in this example, a vertical stroke of 0.458 mm, resulting in a flattened corneal area with a diameter of about 5 mm, referred to as the meniscus).

[0032] Figure 8C The same suction ring is shown placed on a model of a smaller-sized eye (21 mm diameter). Without corneal flattening, the lower end 21a of the skirt 21 cannot reach the eye surface, and a gap exists between the lower end 21a and the eye surface (1.451 mm in the illustrated example). This gap is larger than that in the case of a normal-sized eye. Therefore, as... Figure 8D As shown, for smaller eye models, the cornea needs to be flattened more. In this example, the vertical stroke is 1.451 mm (resulting in a corneal area with a diameter of approximately 9 mm that is flattened) before the lower end 21a can touch the eye surface to form a seal.

[0033] Figure 8E The same suction ring is shown placed on a model of a larger eye (27 mm in diameter). For this eye size, the contact between the lens and the cornea and the contact between the skirt and the eye occur roughly simultaneously; that is, the skirt does not need to be flattened to touch the eye surface to form a seal.

[0034] In a preferred embodiment of the invention, various parameters of the suction ring 11 are optimized to accommodate a wider range of eye sizes and shapes, particularly smaller eyes, while achieving desired performance goals. These goals include reducing interference with the patient's orbital bone, reducing contact pressure on the eye, reducing intraocular pressure (IOP) increases, and preventing eye movement. The optimal ranges and choices of these parameters are selected based on numerical modeling, benchtop studies, and clinical testing. The analyses and studies conducted include finite element analysis (FEA) simulations of various models, video observation of the docking process, IOP measurements, etc. During benchtop studies, the patient interface device with optimized parameters was able to accommodate eyes of different sizes and minimize eye displacement. Data analysis confirmed that pupil movement was less than 300 micrometers in several trials using such a patient interface device.

[0035] refer to Figure 4 and Figure 6A The parameters of the suction ring and their preferred values ​​are described below. Note that... Figure 7A The parameter definitions are the same for suction rings without scleral support pads.

[0036] (1) Skirt outer diameter (OD): The outer diameter of the skirt 21 at its lower end. The skirt OD is preferably 14mm-21mm, more preferably 15mm-19mm. In a particular example, the skirt OD is 19mm. Numerical modeling shows that within the preferred range, increasing the skirt diameter increases the IOP but reduces the contact force at the sides of the skirt. The lower limit of the OD is limited by the size of the contact lens, which is preferably about 13mm. The inventors have tested outer diameter values ​​between 15mm and 20mm and determined their operability, and consider that an OD between 14mm and 21mm is generally suitable.

[0037] (2) Skirt length (L): The vertical (axial) distance from the bottom of the contact lens 17 to the lower end 21a of the skirt 21. The skirt length is preferably 3 mm to 6.5 mm, more preferably 5.47 mm to 5.52 mm. In a specific example, the skirt length is 5.5 mm. Numerical modeling shows that a longer skirt length better accommodates the optimal flattening level during vacuum joining (see...). Figures 8A to 8E (Discussions have been conducted on this topic), and while it increases rotational resistance, it also increases IOP. Laboratory tests showed that a longer skirt reduces the flattening force and meniscus at the capture point (seal formation point). In some laboratory tests, patient interface devices with warped skirt lengths were compared to those with non-warped skirts; it has been demonstrated that non-warped patient interface devices exhibit less eye displacement or movement when a vacuum is applied compared to those with warped skirts. Additional tests showed that for smaller skirt ODs, such as 16 mm, skirt lengths as low as 3.1 mm successfully achieved a vacuum seal.

[0038] For example, from the perspective of Figures 8A to 8E As can be understood from the previous discussion, the total length L2 of the skirt from the base (where both the skirt 21 and the diaphragm 22 are connected to the base portion 24, see...) Figure 6A Conversely, the skirt length L, defined from the bottom of the contact lens, affects the amount of flattening required before the lower end of the skirt contacts the eye surface. The skirt length L, as defined above, is physically determined by both the length of the skirt and the length of the septum. Therefore, both the skirt and the septum can be lengthened or shortened while keeping the skirt length L constant. The total skirt length L2 itself is less important. In the example above where L = 5.5 mm, the total skirt length L2 is L2 = 7.1 mm, but this value is not limiting and other values ​​can also be used.

[0039] (3) Skirt thickness (T): The thickness of the skirt. The skirt thickness is preferably 0.25 mm to 3 mm, and more preferably 0.42 mm to 0.62 mm. In a specific example, the skirt thickness is 0.5 mm. Within the preferred range, the skirt thickness has a relatively small effect on contact force and IOP, as well as contact force at the sides of the skirt; however, higher thicknesses are associated with higher contact forces at the ends of the skirt. Thicknesses exceeding the preferred range may result in a skirt that is too stiff.

[0040] (4) Skirt gap width (G): The width of the gap between the skirt and the diaphragm at the junction base portion 24. The gap width is preferably 0.55 mm, but values ​​between 0.1 and 0.75 mm can also be used. This parameter does not significantly affect the suction ring performance.

[0041] (5) Stiffness of the skirt material: Preferably 20A-70A hardness (Shore hardness), more preferably 30A-42A. Numerical modeling shows that, within the preferred range, increased stiffness leads to a decrease in IOP and a decrease in contact force at the skirt, regardless of the presence or absence of a scleral support pad. It is also shown that a stiffer skirt combined with a scleral support pad transfers the load to the edges of the skirt, which is desirable when gripping loose conjunctival tissue. In some tests, when the material is too stiff (e.g., 95A), it does not conform to the eye and cannot maintain a vacuum.

[0042] (6) Scleral support pad: As mentioned above, the scleral support pad is optional. It should be noted that... Figure 6A and Figure 6B Corresponding to the suction ring with scleral support pad 23, and Figure 7A and Figure 7B This corresponds to a suction ring without a scleral support pad. When present, the scleral support pad contacts the sclera of the eye when the patient interface is coupled to the eye. When a vacuum is activated, they help maintain the structural integrity of the sclera to reduce IOP (Ingress of Optic Expansion) while still achieving a good vacuum seal between the suction ring and the eye. The role of these scleral support pads is to prevent major deformation of the sclera when the cornea is flattened.

[0043] In embodiments where scleral support pads are used, the width and surface area of ​​the pads are optimized to achieve the aforementioned objectives. In one particular embodiment, 14 scleral support pads are provided, and they are evenly spaced from each other. They are approximately 1.63 mm wide in the circumferential direction and approximately 1.56 mm wide in the radial direction. Their vertical length, measured from the bottom of the contact lens, is approximately 1.20 mm at the radially inner end and approximately 1.91 mm at the radially outer end. These dimensions are not limiting and other values ​​may be used.

[0044] (7) Skirt flare: In Figures 1 to 8EIn the illustrated embodiment, the skirt portion 21 extends substantially vertically from the base portion 24. In some alternative embodiments, the skirt portion may have a slight flare, which can facilitate compression of the suction ring and fit with the eye. A flare in the range of 5 to 8 degrees is preferred. Tests have shown that a 10-degree flare does not fit the eye well when the skirt length is between 5.3 mm and 6.6 mm.

[0045] The parameters listed above were adjusted independently during optimization analysis and testing. However, numerical modeling and bench testing showed that the effect of changing one parameter often depends on the values ​​of other parameters as well as eye size. The preferred parameter value ranges described above were obtained after extensive analysis and testing and were determined to be a combination of multiple objectives considered to optimize overall performance.

[0046] Tests were also conducted to compare the one-piece patient interface device with the two-piece patient interface device. The one-piece patient interface device reduces the docking process time by at least 30 seconds. This, in turn, reduces the time the patient spends under vacuum. Tests also showed that eye rotation resistance was increased by more than 50% compared to the two-piece device. The measured IOP increase was approximately 15%–20% smaller compared to the two-piece comparison device. Tests also confirmed that meniscus formation larger than 10 mm in diameter is easier, produces fewer corneal folds, is easier to use, and reduces workflow steps. Additionally, the tubing length was reduced for convenient use during procedures with a lower profile. Furthermore, the one-piece patient interface device eliminates any opportunity for relative mechanical movement between pieces and reduces the number of parts required for the procedure.

[0047] By means of a rotating device (e.g., rotating about 120 degrees or other suitable angle), the tubing guide arm 13 and the suction tubing 14 extend toward the patient's temple. The patient interface device described herein can be used for both the left and right eyes.

[0048] In some alternative embodiments, two or more vacuum ports are provided in the suction ring, which can reduce the chance of eye movement during vacuum application.

[0049] In summary, the one-piece patient interface device according to embodiments of the present invention has the following advantages: reduced skirt outer diameter; adaptation to a wider range of eyes for fitting; reduced interference with the orbital bone that may lead to docking difficulties; reduced occurrence and size of corneal folds during clinical trials; etc.

[0050] The one-piece patient interface device according to embodiments of the present invention is suitable for corneal flap and corneal microlens procedures. Furthermore, the patient interface device can be used for lens refractive index modification, cataract surgery, or other laser applications requiring the patient's eye to be held still while connected to a laser system.

[0051] It will be apparent to those skilled in the art that various modifications and variations can be made to the patient interface device of the present invention without departing from the spirit or scope of the invention. Therefore, the present invention is intended to cover various modifications and variations falling within the scope of the appended claims and their equivalents.

Claims

1. A patient interface device for coupling a patient's eye to an ophthalmic surgical laser system, comprising: A conical base comprising a rigid truncated conical shell configured to couple to the ophthalmic surgical laser system; as well as A flexible suction ring is attached to the lower end of the rigid housing. The conical base and the suction ring are integrally formed as a single piece. The suction ring includes a base portion connected to the lower end of the rigid housing, a circular skirt extending downward from the base portion, a circular diaphragm extending from the base portion and disposed within the skirt, and a contact lens connected to the diaphragm and disposed in a central opening of the diaphragm, wherein when the skirt contacts the surface of the patient's eye, the skirt, the diaphragm, the contact lens, and the surface of the eye form a vacuum chamber.

2. The patient interface device according to claim 1, wherein, The outer diameter of the skirt is between 14 mm and 21 mm, the skirt length, defined as the vertical distance from the lower surface of the contact lens to the distal end of the skirt, is between 3 mm and 6.5 mm, the skirt thickness is between 0.25 mm and 3 mm, and the skirt stiffness is between 20 A and 70 A Shore hardness.

3. The patient interface device according to claim 2, wherein, The outer diameter of the skirt is between 15 mm and 19 mm, the length of the skirt is between 5.47 mm and 5.52 mm, the thickness of the skirt is between 0.42 mm and 0.62 mm, and the stiffness of the skirt is between 30 A and 42 A Shore A hardness.

4. The patient interface device according to claim 2, wherein, The outer diameter of the skirt is 19mm, the length of the skirt is 5.5mm, and the thickness of the skirt is 0.5mm.

5. The patient interface device according to claim 2, wherein, The width of the gap between the skirt and the diaphragm at the location where they connect to the base portion is approximately 5.5 mm.

6. The patient interface device according to claim 1, wherein, The skirt extends vertically from the base.

7. The patient interface device according to claim 1, wherein, The skirt extends from the base with a flare of 5 to 8 degrees.

8. The patient interface device according to claim 1, wherein, The distal portion of the diaphragm extends radially inward to form a flange, and the contact lens is connected to the inner circumference of the flange.

9. The patient interface device according to claim 1, wherein, The suction ring also includes a plurality of scleral support pads connected to the diaphragm and extending downward and evenly spaced in the circumferential direction, wherein the bottom surface of each scleral support pad is inclined, lower at the radially outer end and higher at the radially inner end.

10. The patient interface device according to claim 9, wherein, The scleral support pad has a width of approximately 1.63 mm in the circumferential direction and a width of approximately 1.56 mm in the radial direction. The vertical length of the scleral support pad defined from the bottom of the contact lens is approximately 1.20 mm at the radially inner end and approximately 1.91 mm at the radially outer end.

11. The patient interface device according to claim 1, wherein, The suction ring defines at least one vacuum port that opens on the inner surface of the skirt, and the patient interface device further includes a suction tube coupled to the other end of the vacuum port.

12. The patient interface device according to claim 11, wherein, The conical base also includes a tubular guide arm extending from the housing, and wherein the suction tube extends along the tubular guide arm.

13. The patient interface device according to claim 1, wherein, The cone-shaped base is formed of a rigid plastic material.

14. The patient interface device according to claim 1, wherein, The suction ring is formed of a soft thermoplastic elastomer material.

15. The patient interface device according to claim 1, wherein, The conical base and the suction ring are integrally formed by overmolding.

16. The patient interface device according to claim 1, wherein, The conical base includes a plurality of slot features configured to attach the patient interface device to the ophthalmic surgical laser system.

17. The patient interface device according to claim 1, wherein, The lower surface of the contact lens is either flat or curved.

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