RU2774138C2 - Self-lighting microsurgical device in the form of a cannula - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: inventions group relates to medicine. Cannula devices are provided that are self-illuminating to allow visualization of the cannula devices during a surgical procedure. The self-illuminating element may be provided by phosphors incorporated in the cannula device, for example in a sleeve or sealing element of the cannula device. The cannula device can emit light of a specific color selected according to the size of the cannula device.

EFFECT: use of this group of inventions ensures the introduction of instruments during microsurgical ophthalmic procedures.

9 cl, 5 dwg

Description

FIELD OF TECHNOLOGY

[0001] This application claims the benefit of priority of U.S. Provisional Application No. 62/542,902 titled "Self-Illuminating Cannula Microsurgical Device", filed August 9, 2017, by Joshua Anderson, James Y. Chon, Mark Harrison Farley, and Paul R. Hallen, the contents of which are hereby incorporated by reference in their entirety, as if they were set forth in their entirety in this document.

[0002] The present invention is directed to cannulas for the insertion of instruments during microsurgical procedures and their associated uses.

BACKGROUND OF THE INVENTION

[0003] A number of different types of ophthalmic medical conditions can be treated with microsurgical procedures that involve inserting microsurgical instruments into the human eye. For example, vitreoretinal procedures can be performed to treat conditions such as age-related macular degeneration (AMD), diabetic retinopathy, diabetic vitreous hemorrhage, macular hole, retinal detachment, epiretinal membrane, cytomegalovirus (CMV) retinitis, and a variety of other eye diseases. Vitrectomy procedures involve removing all or part of the vitreous fluid from the eye. In such vitreoretinal procedures, instruments are usually inserted into the eye through the flat part of the ciliary body into the posterior chamber of the eye. Other ophthalmic microsurgical procedures may involve inserting instruments into the eye at other locations.

[0004] With regard to posterior segment surgery, instruments that can be used include, for example, a vitreotome probe, a laser probe, or an ultrasonic fragmentator to cut or fragment tissue. Each instrument can be connected to the control console with a long air pressure line (pneumatic line) and/or power cable, optical cable or flexible tubing to deliver infusion fluid to the surgical site or to withdraw or aspirate fluid and cut/fragmented tissue from site. Instrument cutting, infusion, and aspiration functions can be controlled by a console that not only provides power to surgical instruments (e.g., a reciprocating or rotating cutting blade or needle subjected to ultrasonic vibrations), but can also control the flow of the infusion fluid and provide a source of vacuum (relative to atmosphere). ) to aspirate fluid and cut/fragmented tissue. The surgeon can independently control the functions of the console, for example, through the use of a footswitch or proportional control.

[0005] In ophthalmic microsurgical procedures, the surgeon may need to insert and remove an instrument multiple times, or insert and remove multiple instruments. If the instruments are in direct contact with the incision site, the insertion, manipulation and removal of the instruments may result in injury to the eye. To minimize the need for multiple incisions, ensure easy insertion and retrieval of instruments, reduce trauma at the site of the incision, and promote healing, the surgeon may insert one or more cannulas into the eye, with each cannula serving as an inlet or entry port for introducing instruments into the eye. eye. A typical cannula is a small tube with a sleeve attached. The tube is inserted into the eye, and the sleeve acts as a stop to restrict the tube from advancing into the eye and prevent the tube from being fully inserted into the eye. A sleeve may be attached to the eye to hold the cannula in place. The cannula allows the surgeon to insert one or more microsurgical instruments through a tube into the eye. Examples of cannulas are disclosed in US Pat. No. 8,343,106 and US Pat. No. 8,679,064, the disclosures of which are incorporated herein by reference.

[0006] It is generally desirable to use the smallest size cannula suitable for the instruments used to minimize the size of the incision in the eye. Depending on the size of the incision, the incision may be small enough to make the resulting wound essentially self-healing, thereby eliminating the need for additional procedures to close the incision, such as sutures.

[0007] Multiple cannulas may be inserted when, for example, it is desirable to use multiple instruments at the same time. In some cases, it may be desirable to use different sized cannulas at the same time, such as when it is desirable to use different sized instruments at the same time.

[0008] To help identify which instruments fit which cannula, cannulas have in the past been provided with color coding, with the color indicating the size associated with the cannula. For example, a 23 gauge cannula may contain a sleeve of a first color (eg, orange), a 25 gauge cannula may contain a sleeve of a second color (eg, blue or turquoise), and a 27 gauge cannula may contain a sleeve of a third color (eg, purple). Thus, after the cannula has been placed in the eye, when the surgeon wishes to insert an instrument of a certain size into the eye, the surgeon can determine the dimensions of the cannula by their color to determine the appropriate cannula into which the instrument will be inserted.

SHORT DESCRIPTION

[0009] The present invention is directed to improved cannulas to enable insertion of instruments during microsurgical procedures.

[0010] During ophthalmic surgical procedures, room lighting is often dim. It may be difficult to see cannulas inserted into the eye and it may be difficult to distinguish between different colors of the cannula. In the past, during instrument changes, surgeons often had to turn on the microscope illumination to provide sufficient visual contrast to guide instrument insertion.

[0011] In an exemplary embodiment according to the present disclosure, the cannula device is provided to be self-illuminating. Self-illumination can be provided by phosphors in the cannula device, such as the luminescent pigment used in the manufacture of the cannula device. The device in the form of a cannula contains a cannula tube, a sleeve and, optionally, a sealing element. The phosphors or luminescent pigment may be provided in one or more sleeves, tubes or sealing elements. The phosphors or luminescent pigment may match the color coding of the cannula device associated with the size of the cannula tube.

[0012] In an exemplary method, the first cannula device is provided with a self-illuminating element, such as phosphors or a luminescent pigment, in the sleeve, tube, or sealing element of the first cannula device. The phosphors or luminescent pigment may correspond to a color coding of the first cannula device associated with the size of the first cannula device. The first cannula-like device is inserted into the eye with a tube that provides access to the eye for one or more instruments. The second cannula device may be provided with a self-illuminating element, such as phosphors or a luminescent pigment, in the sleeve, tube, or sealing element of the second cannula device. The phosphors or luminescent pigment may correspond to a color coding of the second cannula device related to the size of the second cannula device, wherein the tube size of the second cannula device is different from the tube size of the first cannula device, and the color of the second cannula device is different from the color of the first cannula device. A second cannula-like device is inserted into the eye with a tube that provides access to the eye for one or more instruments.

[0013] The foregoing general description and the following detailed description are by their nature illustrative and explanatory, and are intended to provide an understanding of the present invention without limiting the scope of the present invention. Accordingly, from the accompanying drawings and the following detailed description, additional aspects, features, and advantages of the present invention will be apparent to those skilled in the art.

BRIEF DESCRIPTION OF GRAPHICS

[0014] The accompanying drawings illustrate embodiments of the devices and methods disclosed in this document and, together with the description, serve to explain the principles of the present invention.

[0015] FIG. 1 shows a cannula tube and a color-coded self-illuminating cap or sleeve according to an embodiment.

[0016] FIG. 2A shows a cannula device comprising the cannula tube and sleeve of FIG. 1 put together.

[0017] FIG. 2B shows a cannula device similar to the cannula device of FIG. 2A, but with different cannula tube size and color coding.

[0018] FIG. 2C shows a cannula device similar to the cannula devices of FIG. 2A and 2B, but with a different cannula tube size and different color coding.

[0019] FIG. 3A shows a cannula device similar to the cannula device of FIG. 2A but with self-illuminating color coding in an elastomeric seal.

[0020] FIG. 3B shows a cannula device similar to the cannula device of FIG. 3A, but with different cannula tube size and different color coding.

[0021] In FIG. 3C shows a cannula device similar to the cannula devices of FIG. 3A and 3B but with different cannula tube size and different color coding.

[0022] FIG. 4 shows the cannula device of FIG. 2A on the trocar inserter.

[0023] FIG. 5 is a block diagram of an embodiment of a method for using a self-illuminating cannula.

[0024] The accompanying drawings can be better understood with reference to the following detailed description.

DETAILED DESCRIPTION OF THE INVENTION

[0025] In order to facilitate an understanding of the principles of the present invention, reference will now be made to the embodiments illustrated in the drawings, and specific terminology will be used to describe them. However, it should be understood that no limitation is intended on the scope of the present invention. Any changes and additional modifications in relation to the described devices, tools, methods, as well as any additional application of the principles of the present invention are absolutely possible, which will be generally obvious to a person skilled in the art to which the present invention pertains. In particular, it is fully contemplated that features, components and/or steps described with respect to one embodiment may be combined with features, components and/or steps described with respect to other embodiments of the present invention. For simplicity, the graphics in some cases use the same reference numbers for the same or similar elements.

[0026] FIG. 1 shows an embodiment of a trocar cannula 101 and a cap or sleeve 103. The cannula 101 may be inserted into the eye to facilitate insertion and removal of instruments during surgery. The cannula 101 may include a tube or shaft 105 capable of passing into the eye (eg, through the sclera, conjunctiva, etc.). In some embodiments, the cannula 101 may be manufactured separately from the sleeve 103 and then attached to the sleeve 103. For example, the cannula 101 may include one or more stops 107 configured to engage corresponding slots 109 in the sleeve 103 (for example, the cannula 101 shown in Fig. 1 contains four stop 107 to engage the four corresponding slots 109 in the sleeve 103). Other types of attachment are also envisaged. For example, cannula 101 may include slots and sleeve 103 may include stops. In some embodiments, the cannula 101 may be attached to the sleeve 103 with adhesive, thermal bonding, etc. In other embodiments, the cannula 101 may be integral with the sleeve 103.

[0027] In some embodiments, the sealing element 111 may be connected to the sleeve 103 or may otherwise be located with the possibility of selectively sealing passing through the cannula 101 (for example, the sealing element 111 may be located at least partially between the shaft 105 and the sleeve 109) . The sealing element 111 may be made of an elastomer (eg silicone). As shown in FIG. 1, the surface of the sealing element 111 may be exposed on the sleeve 103. In some embodiments, the exposed surface of the sealing element 111 may include one or more slots 113 to allow passage of surgical devices or instruments into the cannula 101. In the loosened state of the sealing element 111, that is in the absence of a surgical instrument (or outlet or other element), the slot 113 of the sealing element 111 is closed to prevent fluid flow through the sealing element 111 and thereby seal the fluid passage through the cannula 101. The surgical instrument (or outlet or other element) may be passed through slot 113.

[0028] In some embodiments, sealing element 111 may be attached to sleeve 103 to prevent rotation of sealing element 111 relative to sleeve 103. For example, sealing element 111 may be molded over the inside of a recess and one or more openings in sleeve 103. In some embodiments, implementation sealing member 111 may include a silicon wafer that is formed separately from sleeve 103 and inserted between sleeve 103 and cannula 101 during assembly of sleeve 103 on cannula 101. In such a case, sealing element 111 may be attached to sleeve 103 and cannula 101 by a friction fit. Other types of attachment (eg, adhesive) are also contemplated.

[0029] FIG. 2A depicts an embodiment of an entry port or cannula device comprising a cannula 101 attached to a sleeve 103 (eg, after the stops 107 have been engaged in the respective slots 109). In some embodiments, the anvil/slit interface may prevent sleeve 103 from rotating relative to cannula 101 (eg, during insertion of cannula 101 into the eye). In some embodiments, stops 107 may be configured to permanently hold sleeve 103 on cannula 101 (so that sleeve 103 cannot be removed from cannula 101 without destroying a portion of cannula 101 and/or sleeve 103). For example, stops 107 (and cannula 101) may be made of stainless steel and sleeve 103 may be made of plastic (eg, polycarbonate). Other materials are also provided. Permanent retention between sleeve 103 and cannula 101 may prevent inadvertent removal of sleeve 103 from cannula 101 during surgery (eg, vitreoretinal surgery).

[0030] As can be seen in FIG. 2A, cannula devices as shown in FIG. 2A, and as otherwise disclosed herein in accordance with other embodiments, comprise a small tube with a sleeve at the proximal end of the tube. The tube is inserted into the eye, and the sleeve acts as a stop to restrict the tube from advancing into the eye and prevent the tube from being fully inserted into the eye. A sleeve may be attached to the eye to hold the cannula in place.

[0031] Cannula devices as shown in FIG. 2A, and as otherwise disclosed herein in accordance with other embodiments, may be provided in a variety of sizes, having different tube sizes to accommodate different sized instruments. Examples of cannula sizes suitable for ophthalmic surgical procedures include, for example, 20 gauge, 23 gauge, 25 gauge, 27 gauge, etc. The cannula 101 of FIG. 2A may be, for example, a 23 gauge cannula.

[0032] To help determine the size of the cannula and to help determine which instruments fit which cannula, the cannula device may be color-coded, with the color indicating the size associated with the cannula. For example, a 23 gauge cannula may have a first color, a 25 gauge cannula may have a second color, and a 27 gauge cannula may have a third color. The color coding may be on any visible part of the cannula device, including the sleeve, seal, and/or tube. With the help of color coding, after the cannulas are placed in the eye, the surgeon can determine the dimensions of the cannula by their color to determine the appropriate cannula for the insertion of the instrument.

[0033] During use of the prior devices in low light in a surgical room, it may be difficult for a surgeon to see the cannula devices and/or their color. This may require the illumination of the microscope or other light source to be turned on so that the surgeon can see the cannula-like devices for changing instruments, which may be undesirable. For example, this may cause the surgeon's eyes to adjust to brighter light and then re-adjust when the microscope illumination or other light is turned off, which will take time during the procedure.

[0034] In accordance with the exemplary embodiments described herein, the cannula device may be self-illuminating (eg, at least partially made from a self-illuminating material). The self-illuminating material may be a material which, for example, contains a luminescent pigment. Self-illumination can help the surgeon see the location of the cannula device and can help the surgeon see any color coding and thereby determine the size of the cannula device.

[0035] In the exemplary embodiment shown in FIG. 2A, sleeve 103 may be self-illuminating, such as being luminescent. The pigment used to color-code the sleeve 103 may be a luminescent pigment. The cannula device of FIG. 2A is color-coded with a first color (eg orange) to indicate the size of the cannula, eg 23 gauge.

[0036] FIG. 2B shows a cannula device similar to the cannula device of FIG. 2A, but with different cannula tube size and color coding. In the exemplary embodiment shown in FIG. 2B, sleeve 103 is also self-illuminating, such as being luminescent. As in the case of FIG. 2A, the pigment used to color-code the sleeve 103 may be a luminescent pigment. The cannula device of FIG. 2B is color-coded with a second color (eg blue or turquoise) to indicate cannula size, eg 25 gauge.

[0037] FIG. 2C shows a cannula device similar to the cannula devices of FIG. 2A and 2B, but with a different cannula tube size and different color coding. In the exemplary embodiment shown in FIG. 2C, sleeve 103 is also self-illuminating, such as being luminescent. As in the case of FIG. 2A and 2B, the pigment used to color-code the sleeve 103 may be a luminescent pigment. The cannula device of FIG. 2C is color-coded with a third color (eg purple) to indicate cannula size, eg 27 gauge.

[0038] FIG. 3A, 3B, and 3C depict cannula devices similar to the cannula devices of FIG. 2A, 2B, and 2C, but with self-illuminating color coding in the elastomeric sealing member 111. In each of FIGS. 3A, 3B, and 3C, sealing member 111 is self-illuminating by being luminescent. The pigment used to color-code the sealing member 111 may be a luminescent pigment. The cannula device of FIG. 3A is color-coded with a first color (eg orange) to indicate the size of the cannula, eg 23 gauge. The cannula device of FIG. 3B is color-coded with a second color (eg blue or turquoise) to indicate cannula size, eg 25 gauge. The cannula device of FIG. 2C is color-coded with a third color (eg purple) to indicate cannula size, eg 27 gauge.

[0039] The self-illumination function may be incorporated into any visible portion of the cannula device, including the sleeve, seal, and/or tube. Self-illumination provides a "glow in the dark" effect that makes the cannula device visible in a dim or dark surgical room. This feature can facilitate in situ visualization of cannula devices without active illumination, facilitate insertion of an instrument into cannula devices, and/or check the color coding of cannula devices to verify caliber size.

[0040] In exemplary embodiments in which the self-illuminating function is provided by all or part of the cannula device that is luminescent, luminescence can be excited to its bright operating state by exposure to microscope illumination during routine surgical insertion of the cannula device into the eye. Alternatively, a separate light source can be used to make the cannula device more luminesce. When activated by a microscope or otherwise, the luminescence of the cannula device emits a soft light that is visible when the microscope illumination or other illumination is turned off. The fluorescent light may be a color-coded light associated with a particular caliber indicating the size of the cannula.

[0041] Due to the self-illumination function, the efficiency of surgical intervention is increased without significant cost or complexity. This feature eliminates the need to turn on the microscope backlight during a procedure so that the surgeon can see cannula devices in place.

[0042] Desired portion(s) of cannula devices can be made luminescent by incorporating suitable phosphors into the fabrication material to make the material self-illuminating. For example, the phosphors can be mixed with the plastic used to make the sleeve and/or the elastomer (eg silicone) used to make the sealing element. Examples of phosphors include zinc sulfide and strontium aluminate. The phosphors can be charged with normal light, such as light from a microscope or in a room, and the resulting glow can last long enough for the duration of a surgical procedure. Phosphors absorb light when energized and release stored energy to glow when the light is off or dim. Phosphors can be chosen to give visible light the desired color upon activation. The use of luminescent pigments and/or dopants may be chosen to provide the desired illumination.

[0043] FIG. 4 shows an embodiment of the self-illuminating cannula device on the trocar inserter 501. In some embodiments, the trocar inserter 501 may include a trocar blade 503 attached to a handle 505. In some embodiments, the handle 505 may be made of plastic and the blade 503 may be made of stainless steel. Other materials are also provided. The trocar blade 503 may extend beyond the end of the shaft 105 of the cannula device and may include one or more sharp edges for puncturing the eye (e.g., piercing a hole through the sclera and into the vitreous) to introduce the cannula 101. In some embodiments, the guide 507 may be inserted into the guide slot 115 of the cannula device to prevent the cannula device from rotating relative to the handle 505 during insertion of the cannula device into the eye. In some embodiments, the guide 507 may releasably engage with the guide slot 115 such that when the trocar inserter 501 is removed from the cannula device, the guide 507 does not pull the cannula device out of the eye. For example, the guide 507 may frictionally engage with the guide slot 115 with a friction force that is less than the friction force applied by the eye to the outer sides of the cannula 101 when the cannula 101 is in the eye.

[0044] FIG. 5 is a block diagram of an embodiment of a method for using a self-illuminating cannula. The elements shown in the block diagram are illustrative only. Various elements shown may be omitted, additional elements may be added, and/or various elements may be performed in a different order from the following.

[0045] At 501, there may be. The cannula device may contain a self-illuminating material (eg, phosphors) that emits light to allow the cannula device to be visualized. For example, the sleeve may comprise a self-illuminating material. In some embodiments, the cannula device may include a sealing element configured to seal the passage through the tube when the sealing element is in a loosened state. In some embodiments, the implementation of the sealing element may contain self-illuminating material.

[0046] In step 503, the cannula device may be inserted at the desired site for surgical insertion of the surgical instrument.

[0047] In step 505, the cannula device may be illuminated to activate the phosphors so that they enter an activated state. The phosphors, when activated, can emit color-coded light corresponding to the size of the cannula device.

[0048] In some embodiments, at step 507, a second cannula device (where the previously mentioned cannula device is the first cannula device) may be applied. The second cannula device may include a tube configured to insert a second surgical instrument with a sleeve at the proximal end of the tube. The second cannula device can also be self-illuminating. In some embodiments, the first and second cannula devices may be of different sizes.

[0049] At 509, a second cannula device may be inserted at a desired location for surgical insertion of a second surgical instrument.

[0050] In step 511, after insertion of the second cannula device, the second cannula device may emit light to allow visualization of the second cannula device. In some embodiments, the first cannula device may emit light of a first color corresponding to the size of the first cannula device, and the second cannula device may emit light of a second color corresponding to the size of the second cannula device. In some embodiments, the second color may be different from the first color.

Those skilled in the art will appreciate that the embodiments encompassed by the present invention are not limited to the specific exemplary embodiments described above. Therefore, while the exemplary embodiments have been shown and described, the above invention includes many modifications, changes, and substitutions. It should be understood that such variations may be made with respect to the foregoing without departing from the scope of the present invention. Accordingly, the appended claims are to be construed broadly and in accordance with the present invention.

Claims (25)

1. An ophthalmic device in the form of a cannula for an ophthalmic surgical procedure, comprising: a tube configured to insert an ophthalmic surgical instrument, and a sleeve at the proximal end of the tube, said sleeve being configured to act as a stopper restricting the passage of the tube into the eye to prevent full insertion of the tube into the eye, and a sealing element adapted to seal the passage through the tube when the sealing element is in a loosened state, wherein the sealing element contains one or more slots to allow passage of an ophthalmic surgical instrument, the sealing element is color-coded to indicate the size of the cannula device, wherein the sleeve contains a self-illuminating material and surrounds a color-coded sealing element that does not contain a self-illuminating material, so that the sleeve is located around one or more slots in the sealing element for inserting an ophthalmic surgical instrument into one or more slots during an ophthalmic surgical procedure. 2. The cannula device of claim 1, wherein the sleeve contains phosphors which make the sleeve self-illuminating. 3. The cannula device of claim 2, wherein the phosphors, when activated, emit color-coded light corresponding to the size of the cannula device. 4. The apparatus of claim 2, wherein the phosphors contain zinc sulfide. 5. The apparatus of claim 2, wherein the phosphors comprise strontium aluminate. 6. The device of claim 1, wherein the collar or seal is purple to indicate a 27 gauge cannula device, blue to indicate a 25 gauge cannula device, or orange to indicate a 23 gauge cannula device. 7. A method for facilitating an ophthalmic surgical procedure, comprising: using a device in the form of a cannula, containing a tube configured to insert an ophthalmic surgical instrument, and a sleeve at the proximal end of the tube, wherein said sleeve is configured to act as a limiter that limits the advancement of the tube into the eye to prevent complete insertion of the tube into the eye, a sealing element adapted to seal the passage through the tube when the sealing element is in a loosened state, wherein the sealing element contains one or more slots to allow passage of an ophthalmic surgical instrument, the sealing element is color-coded to indicate the size of the cannula device, wherein the sleeve contains a self-illuminating material and surrounds a color-coded sealing element that does not contain a self-illuminating material, such that the sleeve is located around one or more slots in the sealing element for inserting an ophthalmic surgical instrument into one or more slots during an ophthalmic surgical procedure; and inserting a cannula device at a desired surgical insertion site for an ophthalmic surgical instrument; wherein the cannula device emits light which enables visualization of the cannula device. 8. The method of claim 7, wherein the sleeve contains phosphors that make the cannula device self-illuminating; the method further comprising illuminating the sleeve to activate the phosphors so that they enter an activated state, wherein the phosphors, when in an activated state, emit color-coded light corresponding to the size of the cannula device. 9. The method of claim 7, wherein the cannula device is the first cannula device, the tube is the first tube, and the sleeve is the first sleeve, and the method further comprises: using a second cannula device comprising a second tube capable of inserting a second ophthalmic surgical instrument and a second sleeve at the proximal end of the second tube, the second cannula device being self-illuminating; inserting a second cannula device at a desired surgical insertion site for a second ophthalmic surgical instrument; wherein, upon insertion of the second cannula device, the second cannula device emits light to aid in visualizing the second cannula device; wherein the first tube has a size different from that of the second tube; wherein the first cannula device is configured to emit light of a first color corresponding to the size of the first cannula device; and wherein the second cannula device is configured to emit light of a second color corresponding to the size of the second cannula device, the second color being different from the first color.

Images