Blade systems for microkeratomes with channels to stabilize movement

Abstract

Blade systems for microkeratomes having channels to stabilize movement are disclosed. In one aspect, a microkeratome blade system (305) includes a blade having a cutting edge (500). The microkeratome blade system (305) includes a blade holder (304) connected to the blade. The blade holder (304) defines one or more surfaces for movement on a portion of the holder of a microkeratome head during a blade operation. The blade holder (304) defines a channel (510) that extends substantially along the same direction as the cutting edge (500). The channel (510) is shaped and dimensioned to fit a corresponding protrusion formed in the microkeratome head. Figure for the abstract: 2.

Description

Title of the invention: MICROKERATOME BLADE SYSTEMS HAVING CHANNELS FOR STABILIZING A MOVEMENT Technical field

[0001] The presently disclosed subject matter generally relates to medical devices for incising a cornea. In particular, the presently disclosed subject matter relates to microkeratome blade systems having channels for stabilizing movement. BACKGROUND

[0002] Laser in situ keratomileusis (LASIK) is a commonly used eye surgery technique to correct nearsightedness and farsightedness, and to cure astigmatism. This technique is performed by an ophthalmologist who uses a laser or microkeratome to reshape the cornea of ​​the eye to improve visual acuity. LASIK can provide an alternative solution for people who wear glasses or contact lenses to correct a vision problem.

[0003] Using a microkeratome for a LASIK procedure involves placing a vacuum ring on a cornea. A microkeratome drive mechanism is used to move a blade across the cornea while the cornea is held by the vacuum ring. The blade is moved in an alternating transverse direction to incise the eye. This creates a lamellar flap of the cornea that is folded back so that the stromal bed of the cornea can be ablated with a laser to correct the vision problem.

[0004] Microkeratomes typically consist of three components: a handpiece that contains two motors, a head that holds the blade, and a vacuum ring that applies suction to maintain the position of the microkeratome relative to the cornea. Accuracy of the procedure is very important to ensure that the cornea is incised correctly. Therefore, stabilizing any of the components of the microkeratome during the operation is beneficial. Brief description of the drawings

[0005] Having thus described the presently disclosed subject matter in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and in which:

[0006] [Fig.l] is a perspective view of a microkeratome according to the present disclosure;

[0007] [Fig.2] is a side view of the microkeratome shown in [Fig.l];

[0008] [Fig.3] is a front view of a lower portion of the microkeratome without the head so that a blade can be seen;

[0009] [Fig.4] illustrates a top perspective view of the head, blade and blade holder;

[0010] [Fig.5] is a side view of the blade system in operational position at the inside of the microkeratome head; and

[0011] [Fig.6]

[0012] [Fig.7]

[0013] [Fig.8]

[0014] [Fig.9]

[0015] [Fig. 10] are further views of the blade system and microkeratome head. Statement of the invention

[0016] The presently disclosed subject matter relates to microkeratome blade systems having channels for stabilizing movement. In one aspect, a microkeratome blade system includes a blade having a precise cutting edge. The microkeratome blade system includes a blade holder connected to the blade. The blade holder defines one or more surfaces for movement on a support portion of a microkeratome head during an operation of the blade. The blade holder defines a channel that extends substantially along the same direction as the cutting edge. The channel is shaped and sized to conform to a corresponding projection formed in the microkeratome head.

[0017] In another aspect, a microkeratome includes a microkeratome head including a support portion. The microkeratome head also defines a projection. The microkeratome blade system also includes a blade including a cutting edge. Further, the microkeratome blade system includes a blade holder connected to the blade. The blade holder defines one or more surfaces for movement on the support portion of the microkeratome head during an operation of the blade. The blade holder defines a channel that extends substantially along the same direction as the cutting edge. Further, the channel is shaped and sized to conform to the projection formed in the microkeratome head.

[0018] According to one embodiment, the present invention relates to a microkeratome blade system comprising:

[0019] a blade having a cutting edge; and

[0020] a blade holder connected to the blade, wherein the blade holder defines one or more surfaces for movement on a support portion of a microkeratome head during an operation of the blade, wherein the blade holder defines a channel that extends substantially along the same direction as the cutting edge, and wherein the channel is shaped and sized to fit a corresponding projection formed in the microkeratome head.

[0021] Advantageously, the cutting edge may be substantially straight.

[0022] According to one possible implementation, the channel extends in a direction substantially parallel to the direction of operational movement of the blade.

[0023] According to one embodiment, the channel is curved, trapezoidal, square or triangular in shape.

[0024] According to a particular embodiment, the channel may be concave in shape.

[0025] Advantageously, the corresponding projection formed in the microkeratome head may be curved, trapezoidal, square or triangular in shape.

[0026] According to one embodiment, the corresponding projection formed in the microkeratome head is convex in shape.

[0027] According to one embodiment, the cutting edge is oriented in a first direction, and

[0028] wherein the channel defines a surface having portions that are oriented in a plurality of directions, and wherein one of the plurality of directions is a second direction that is substantially opposite the first direction.

[0029] Advantageously, at least one of the plurality of directions is a third direction which is orthogonal to the first direction.

[0030] According to another embodiment, the corresponding projection has a plurality of surfaces which are oriented in directions which are substantially opposite to the directions in which the surface of the channel is oriented.

[0031] According to another aspect, the present invention relates to a Microkeratome comprising:

[0032] a microkeratome head comprising a support portion and which defines a projection; and

[0033] a microkeratome blade system comprising:

[0034] a blade having a cutting edge; and

[0035] a blade holder connected to the blade, wherein the blade holder defines one or more surfaces for movement on the support portion of the microkeratome head during an operation of the blade, wherein the blade holder defines a channel that extends substantially along the same direction as the cutting edge, and wherein the channel is shaped and sized to fit the protrusion formed in the microkeratome head.

[0036] Advantageously, the cutting edge is substantially straight.

[0037] According to one embodiment of the microkeratome, the channel extends in a direction substantially parallel to the direction of operational movement of the blade.

[0038] A particular implementation provides a channel of curved, trapezoidal shape, square or triangular.

[0039] Advantageously, the channel may be concave in shape.

[0040] According to one possible implementation, the corresponding projection formed in the microkeratome head is curved, trapezoidal, square or triangular in shape.

[0041] According to one embodiment, the corresponding projection formed in the microkeratome head is convex in shape.

[0042] Advantageously, the cutting edge is oriented in a first direction and the channel defines a surface having portions that are oriented in a plurality of directions, one of the plurality of directions being a second direction that is substantially opposite the first direction.

[0043] One of the plurality of directions may be a third direction that is orthogonal to the first direction.

[0044] Advantageously, the corresponding projection has a plurality of surfaces which are oriented in directions which are substantially opposite to the directions in which the surface of the channel is oriented.

[0045] According to another aspect, the present invention relates to a microkeratome comprising:

[0046] a microkeratome head having a support portion and which defines a channel; And

[0047] a microkeratome blade system comprising:

[0048] a blade having a cutting edge which extends substantially along the same direction as the channel; and

[0049] a blade holder connected to the blade, wherein the blade holder defines one or more surfaces for movement on the support portion of the microkeratome head during an operation of the blade, wherein the blade holder defines a projection that is shaped and sized to conform to the channel formed in the microkeratome head.

[0050] Advantageously, the channel can be curved, trapezoidal, square or triangular in shape. DETAILED DESCRIPTION

[0051] The following detailed description is made with reference to the figures. Exemplary embodiments are described to illustrate the disclosure, not to limit its scope, which is defined by the claims. Those skilled in the art will recognize a number of equivalent variations in the following description.

[0052] The articles "a" and "an" are used herein to refer to one or more than one (i.e., at least one) of the grammatical object of the article. For example, "an element" means at least one element and may include more than one element.

[0053] Use herein of the terms "comprising," "comprising," or "having," and variations thereof, is intended to encompass the elements listed below and equivalents thereof as well as additional elements. Embodiments cited as "comprising," "comprising," or "having" certain elements are also contemplated as "consisting essentially of" and "consisting of" such certain elements.

[0054] The ranges of values ​​cited herein are merely intended to serve as a shorthand method for individually referring to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if individually cited herein. For example, if a range is indicated as being between 1% and 50%, it is intended that values ​​such as between 2% and 40%, 10% and 30%, or 1% and 3%, etc., be expressly listed in this specification. These are merely examples of what is specifically intended, and all possible combinations of numerical values ​​between and including the lowest and highest listed values ​​should be considered expressly listed in this disclosure.

[0055] Unless otherwise indicated, all technical terms used in this document have the same meaning as commonly understood by those skilled in the art to which this disclosure pertains.

[0056] [Fig. 1] illustrates a perspective view of a microkeratome 100 according to the present disclosure. Referring to [Fig. 1], the microkeratome 100 includes a handpiece 102 that is connected to a head 104 and a vacuum ring system 106. The microkeratome 100 may be used for incision of a lamellar flap in a cornea as part of a LASIK procedure. The vacuum ring system 106 may be connected to a vacuum source to create suction pressure between the vacuum ring system 106 and the cornea. The suction pressure secures the microkeratome 100 to the cornea. The handpiece 102 may include a wire system 108 that is connected to an electrical console, which is not shown for ease of illustration but should be understood by those skilled in the art. The console can provide electrical power to operate the microkeratome 100.

[0057] The head 104 generally has a front side 110, a rear side 112, a bottom side 114, and a top side 116. The head 104 defines a blade cavity 118 that can receive a blade, or a blade and a blade holder to which the blade is connected (not shown). The vacuum ring system 106 may have a helical toothed member 120 that can be coupled to the handpiece 102. For example, the helical toothed member 120 may be coupled to an internal toothed member (not shown) of the handpiece 102 at a coupling location 122. The handpiece 102 has a motor (not shown) that cooperates with the helical toothed element 120 to move the head 104 and the blade in a linear direction (indicated generally by a double arrow 124) over an opening 126 of the vacuum ring system 106. The opening 126 is defined through an upper surface 128 of the vacuum ring system 106 that is oriented toward the lower side 114 of the head 104 and its blade. The cornea may protrude through the opening 126.

[0058] To accurately guide the head 104 and blade along the linear direction 124, the head 104 and the vacuum ring system 106 may have one or more corresponding linear bearing members such as, for example, one or more corresponding tongues 130 and grooves 132, respectively, which create linear bearings. In this example, the tabs 130 are formed on the head 104, and the grooves 132 are formed on the vacuum ring system 106. In another example, the tabs 130 may be formed on the vacuum ring system 106, and the grooves 132 may be formed on the head 104. In another example, the head 104 may have a tab 130 that movably engages a corresponding groove 132 of the vacuum ring system 106, and the head 104 may also have a groove 132 that engages a corresponding tab 130 of the vacuum ring system 106.

[0059] [Fig. 2] illustrates a side view of the microkeratome 100 shown in [Fig. 1]. [Fig. 2] shows a side of the microkeratome 100 that is opposite the side shown in [Fig. 1]. In the side view of [Fig. 2], it can be seen that the cavity 118 extends between the sides of the microkeratome 100. The handpiece 102 may include another motor (not shown due to its internal placement) that moves the blade in a reciprocating (or oscillating) lateral manner (i.e., orthogonal or transverse to the linear direction 124 along which the head 104 moves) so that the blade incises the corneal tissue and creates a lamellar flap. For example, [Fig. 3] illustrates a front view of a lower portion of the microkeratome 100 without the head 104 so that a blade 302 can be seen. Referring to [Fig. 3], this other motor may drive the rotation of a shaft 300.When the head 14 is connected to the handpiece 12 in this example, the shaft 300 extends through a coupling member (not shown) generally disposed at or near the upper side 116 of the head 104 to engage the blade 302 (or blade holder). The coupling member or some other portion of the structure of the head 104 may suitably connect the head 104 to, and separate the head 104 from, the handpiece 102. The blade 302 is connected to a blade holder 304 to form a blade system 305. The blade 302 may be made of metal, and the base 304 may be made of plastic or other suitable medical-grade material. The blade 302 and the blade holder 304 are sized and shaped for insertion into and positioning with the blade cavity 118 such. as described in more detail herein. The movement of the blade 302 in conjunction with the blade holder 304 during an operation is indicated by the double arrow 306.

[0060] Returning to [Fig.l], the vacuum ring system 106 may include a suction connector 134. The suction connector 134 is connected to a suction tube (not shown) and is coupled to suction openings (not shown) in the vacuum ring. The suction connector 134 may have a collar 136 that limits the travel of the head 104 and the blade 302. The suction connector 134 may have a threaded shaft (not shown) that screws into a corresponding threaded opening (not shown) of the vacuum ring system 106.

[0061] [Fig. 4] illustrates a top perspective view of the head 104, the blade 302, and the blade holder 304. Referring to [Fig. 4], the head 104 includes a coupling member 400 that can receive the shaft 300 shown in [Fig. 3]. In this figure, the blade 302 and the blade holder 304 are shown as being spaced from the head 104 for ease of illustration. In order to be positioned for operation with the head, the blade 302 and the blade holder 304 can be moved generally in the direction indicated by the arrow 402 until they are in the position as shown in [Fig. 3]. In this manner, the blade 302 and the blade holder 304 can enter the blade cavity 118.

[0062] The shaft 300 may extend through the coupling member 400. In particular, the coupling member 400 may define an opening 404 for insertion of the shaft 300. The coupling member 400 or some other portion of the structure of the head 104 may define a groove 406 used to connect the head 104 to, and separate the head 104 from, the handpiece 102.

[0063] The shaft 300 may engage the blade 302 to swing the blade 302 in the directions indicated by the arrow 306 when the shaft 300 is rotated. Referring to [Fig. 3], an eccentric pin 308 at one end of the shaft 300 may engage a slot 310 of the blade holder 304. Rotation of the shaft 300 causes the eccentric pin 308 to move the blade holder 304 and the blade 302 along the directions indicated by the arrow 306.

[0064] [Fig. 5] illustrates a side view of the blade system 305 in an operative position within the microkeratome head 104. Referring to [Fig. 5], the blade 302 has a cutting edge 500 that extends through an opening 502 at the underside 114 of the microkeratome head 104. The cutting edge 500 is positioned to engage and incise a cornea when the microkeratome head 104 is advanced forward in the direction indicated by the arrow 504. The cutting edge 500 is oscillated in a direction orthogonal to this direction (indicated by the arrow 504) when incising the cornea.

[0065] Upon engagement with the cornea, the blade system 305 is pushed rearwardly (in a direction generally opposite the direction of the arrow 504). As a result, a rearward portion of the blade system 305 engages a rearward side 506 of the blade cavity 118. In particular, the surfaces 508 of the blade holder 304 contact the rearward side 506 of the blade cavity 118 and may slide on the rearward side 506 while the blade system 305 oscillates. The surfaces of the blade cavity 118 in contact with the blade system 305 as shown function as part of a support portion of the microkeratome head 104 and may be so referred to. For example, one or more surfaces of the rearward side of the blade cavity 118 may be a support for the blade system 305 during an incision operation.

[0066] The blade system 305 may be held in place during an operation by the shaft 300. [Fig. 3] shows the shaft 300 in position to fit within the slot 310. The offset cylindrical projecting portion of the eccentric pin 308 is coupled to the slot 310 in the blade holder 304 to prevent it from being moved unless the blade system 305 is removed from the handpiece 102 and the shaft 300. In addition, the shaft 300 may be spring-loaded such that if it is not aligned with the slot 310 when the head is connected to the handpiece 102, it will find its place once it begins to rotate as the spring pushes it down when the eccentric pin 308 overlaps the slot 310. When these parts are properly coupled, the blade 302 cannot move unless the shaft 300 rotates.

[0067] The stability of the blade system 305 is beneficial in providing a precise incision of the cornea. For improved stability, the blade holder 304 defines a channel 510 that extends substantially along the same direction as the cutting edge 500. The channel 510 is shaped and sized to conform to a corresponding protrusion 512 formed in the microkeratome head 104. The protrusion 512 tightly conforms to the channel 510 such that stabilization of the blade system 305 is increased. Furthermore, the protrusion 512 tightly conforms to the channel 510 along its length such that stability is provided over the entire distance of movement while the blade system 305 oscillates.

[0068] The channel 510 is substantially curved in shape. Furthermore, the channel 510 is concave in shape. However, the channel 510 may alternatively be of any other suitable shape and size. For example, the channel 510 may be trapezoidal, square, or triangular in shape. The channel 510 extends between the sides of the blade holder 304.

[0069] It should be noted that, alternatively, channel 510 and projection 512 may be interchanged. That is, rather than channel 510 being formed in blade holder 304, it may be replaced with a projection similar to projection 512. Furthermore, in this example, projection 512 may be replaced with a channel similar to channel 510. The operation in this example may be similar to that described in other examples provided here.

[0070] The projection 512 formed in the microkeratome head is convex in shape. In this example, the projection 512 is curved and shaped such that it closely matches the shape of the channel 510. In other examples and such that it will conform to a correspondingly shaped channel, the projection 512 may be trapezoidal, square, or triangular in shape.

[0071] Still referring to [Fig. 5], the cutting edge 500 is oriented in a direction generally in the direction of arrow 514. The channel 510 defines a smooth surface as shown, but it can be considered to have portions that are oriented in multiple different directions. At least one of the portions of the channel 510 is oriented in a direction that is substantially opposite the direction of arrow 514. Other directions in which the surface portions are oriented include a direction of arrow 516 or a direction opposite arrow 516 (orthogonal to the direction of arrow 514). Furthermore, the surface portions are oriented in directions between the direction of arrow 516 and the direction opposite arrow 516. In this way, the channel 510 can securely conform to the corresponding shape of the projection 512 to stabilize the movement of the blade.Furthermore, it should be noted that in this example, the surface portions are smooth due to the curved shape, but alternatively, the surfaces may not be smoothly connected and have a more distinct shape, such as a hexagonal-like shape.

[0072] FIGs. 6-10 illustrate alternative views of the blade system 305 and the microkeratome head 104. For ease of illustration, the blade system 305 is positioned away from the microkeratome head 104. [Fig. 6] illustrates a rear top perspective view, [Fig. 7] illustrates a bottom perspective view, [Fig. 8] illustrates a front top perspective view, [Fig. 9] illustrates another bottom perspective view, and [Fig. 10] illustrates a rear view.

[0073] It should be noted that the microkeratome may be of any suitable material. For example, the head may be made of a stainless steel material that is electroplated with aluminum (e.g., MEDCOAT 2000™ by The Electrolizing Corporation of Ohio). The blade may be made of stainless steel and conform to ASTM A-176. The blade holder may be made of a copolymer or a polyoxymethylene copolymer.

[0074] Although the embodiments have been described in connection with the various embodiments of the various figures, it is understood that other similar embodiments may be used, or modifications and additions may be made to the described embodiment to achieve the same function without departing therefrom. Therefore, the disclosed embodiments should not be limited to a any single embodiment, but rather must be interpreted within the scope and scope of the appended claims.

Claims

Claims

1. A blade system (305) for a microkeratome comprising: a blade (302) having a cutting edge (500); and a blade holder (304) connected to the blade, wherein the blade holder (304) defines one or more surfaces for movement on a support portion of a microkeratome head (104) during operation of the blade, wherein the blade holder (304) defines a channel (510) extending substantially along the same direction as the cutting edge (500), and wherein the channel (510) is shaped and sized to conform to a corresponding projection formed in the microkeratome head.

2. The microkeratome blade system (305) of claim 1, wherein the cutting edge (500) is substantially straight.

3. The microkeratome blade system (305) of claim 1, wherein the channel (510) extends in a direction substantially parallel to the direction of operational movement of the blade.

4. The microkeratome blade system (305) of claim 1, wherein the channel (510) is curved, trapezoidal, square, or triangular in shape.

5. The microkeratome blade system (305) of claim 1, wherein the channel (510) is concave in shape.

6. The microkeratome blade system (305) of claim 1, wherein the corresponding projection formed in the microkeratome head is curved, trapezoidal, square, or triangular in shape.

7. The microkeratome blade system (305) of claim 1, wherein the corresponding projection formed in the microkeratome head is convex in shape.

8. The microkeratome blade system (305) of claim 1, wherein the cutting edge (500) is oriented in a first direction, and wherein the channel (510) defines a surface having portions that are oriented in a plurality of directions, and wherein one of the plurality of directions is a second direction that is substantially opposite the first direction.

9. The microkeratome blade system (305) of claim 8, wherein at least one of the plurality of directions is a third direction that is orthogonal to the first direction.

10. The microkeratome blade system (305) of claim 8, wherein the corresponding projection has a plurality of surfaces that are oriented in directions that are substantially opposite to the directions in which the channel surface (510) is oriented.

11. A microkeratome (100) comprising: a microkeratome head (104) having a support portion and defining a projection; and a microkeratome blade system (305) comprising: a blade (302) having a cutting edge (500); and a blade holder (304) connected to the blade, wherein the blade holder (304) defines one or more surfaces for movement on the support portion of the microkeratome head during an operation of the blade, wherein the blade holder (304) defines a channel (510) extending substantially along the same direction as the cutting edge (500), and wherein the channel (510) is shaped and sized to fit the projection formed in the microkeratome head.

12. The microkeratome (100) of claim 11, wherein the cutting edge (500) is substantially straight.

13. The microkeratome (100) of claim 11, wherein the channel (510) extends in a direction substantially parallel to the direction of operational movement of the blade (302).

14. The microkeratome (100) of claim 11, wherein the channel (510) is curved, trapezoidal, square, or triangular in shape.

15. The microkeratome (100) of claim 11, wherein the channel (510) is concave in shape.

16. The microkeratome (100) of claim 11, wherein the corresponding projection formed in the microkeratome head is curved, trapezoidal, square or triangular in shape.

17. The microkeratome (100) of claim 11, wherein the corresponding projection formed in the microkeratome head is convex in shape.

18. The microkeratome (100) of claim 11, wherein the cutting edge (500) is oriented in a first direction, and wherein the channel (510) defines a surface having portions that are oriented in a plurality of directions, and wherein one of the plurality of directions is a second direction that is substantially opposite the first direction.

19. The microkeratome (100) of claim 18, wherein at least one of the plurality of directions is a third direction that is orthogonal to the first direction.

20. The microkeratome (100) of claim 18, wherein the corresponding projection has a plurality of surfaces that are oriented in directions that are substantially opposite to the directions in which the surface of the channel (510) is oriented.

21. A microkeratome (100) comprising: a microkeratome head having a support portion and defining a channel (510); and a microkeratome blade system (305) comprising: a blade having a cutting edge (500) extending substantially along the same direction as the channel (510); and a blade holder (304) connected to the blade, wherein the blade holder (304) defines one or more surfaces for movement on the support portion of the microkeratome head during an operation of the blade, wherein the blade holder (304) defines a projection that is shaped and sized to fit the channel (510) formed in the microkeratome head.

22. The microkeratome (100) of claim 21, wherein the channel (510) is curved, trapezoidal, square, or triangular in shape.

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