External macular buckling band

Abstract

The present disclosure describes an extrafoveal compression band, which is a compression band for fixing on the eyeball. The compression band includes a bracket and a fixing band connected to the bracket. The bracket includes a shaping member embedded in the bracket, a main body layer having a first hardness, and a covering layer covering the main body layer and having a second hardness and for abutting against the posterior sclera. The shaping member provides a supporting force for the bracket, and the second hardness is not greater than the first hardness; the main body layer includes an arc-shaped and adjustable-arc and plastic strip portion and a supporting portion connected to the strip portion; the covering layer includes a strip portion covering the strip portion and an abutting portion covering the supporting portion and for abutting against the posterior sclera of the eyeball; the fixing band is in a long strip shape, and the fixing band is connected to the supporting portion. Thus, an extrafoveal compression band that is not easily loosened and causes less damage to the eyeball can be provided.

Description

Technical Field

[0001] The present disclosure generally relates to the field of medical devices, and particularly to an extra-macular pressure band. Background Art

[0002] In China, the prevalence of high myopia is high, and the number of people suffering from diseases related to posterior staphyloma is huge. Treating diseases related to posterior staphyloma of high myopia has important medical significance. Posterior staphyloma refers to the outward bulging of the posterior sclera and uvea of the eyeball, mainly manifested as thinning and posterior bulging of the local sclera. The excessive expansion and bulging of the posterior sclera will cause the retinal tissue to be insufficient to cover the expanded sclera. Clinically, patients with posterior staphyloma of high myopia often have progressive deepening of myopia after adulthood, atrophy of the retina and choroid, macular hole, macular retinoschisis, retinal detachment and other pathological manifestations that seriously affect vision.

[0003] In the prior art, posterior scleral reinforcement surgery can be used to inhibit the bulging of the posterior sclera of the eyeball, thereby alleviating the continuous bulging of the posterior sclera of the high myopia eyeball, and further delaying the deepening of the myopia degree. Existing posterior scleral reinforcement surgeries often use a reinforcement device externally applied to the posterior sclera of the macular area of the eyeball.

[0004] However, existing reinforcement devices often encounter some problems during use. For example, the reinforcement device is prone to loosen after being implanted into the eyeball and is likely to cause damage to the eyeball. Summary of the Invention

[0005] The present disclosure is proposed in view of the above situation, and its purpose is to provide an extra-macular pressure band that is not easily loosened and causes less damage to the eyeball.

[0006] To this end, the present disclosure provides an extra-macular pressure band, which is a pressure band for fixing on the eyeball, including a bracket and a fixing band connected to the bracket. The bracket includes a shaping member embedded in the bracket, a main body layer having a first hardness, and a covering layer covering the main body layer and having a second hardness and used for abutting against the posterior sclera. The shaping member provides a supporting force for the bracket, and the second hardness is not greater than the first hardness; the main body layer includes a strip-shaped portion that is arc-shaped and has an adjustable curvature and plasticity, and a supporting portion connected to the strip-shaped portion; the covering layer includes a strip-shaped portion covering the strip-shaped portion and an abutting portion covering the supporting portion and used for abutting against the posterior sclera of the eyeball; the fixing band is strip-shaped, and the fixing band is connected to the supporting portion.

[0007] In the present disclosure, the strip portion has plasticity, which can facilitate the adjustment of the arc of the strip portion; the second hardness of the covering layer is not greater than the first hardness of the main body layer. Supported by the shaping member, the harder main body layer and the softer covering layer can maintain a certain arc, and the arc-shaped strip portion in the main body layer can be not easily deformed after the stent is sutured to the eyeball, thereby enabling the suture position of the stent and the fixation band with the eyeball to be stable. Thus, the pressure band is not easily loosened; the covering layer may include a strip portion and a abutting portion. The softer strip portion adheres to the sclera of the eyeball, and the softer abutting portion abuts against the bulging area of the posterior sclera. Thus, the damage to the eyeball can be relatively small.

[0008] In addition, in the pressure band according to the present disclosure, optionally, the abutting portion protrudes a predetermined height from the surface of the strip portion close to the eyeball. In this case, protruding the predetermined height can facilitate the formation of a micro-convex surface by the abutting portion.

[0009] In addition, in the pressure band according to the present disclosure, optionally, the fixation band and the stent include surgical marks, and the surgical marks are at least one of through holes, semi-through holes, scale lines, edge notches, marked line segments or micro-protrusion marks. In this case, according to different surgical marks and combinations of different surgical marks, it is beneficial for the operator to operate the pressure band according to the surgical marks.

[0010] In addition, in the pressure band according to the present disclosure, optionally, the surgical mark on the fixation band is a through hole, and the surgical mark on the stent is an edge notch. In this case, the operator can observe part of the situation of the eyeball through the through hole, which is beneficial for the operator to suture the fixation band to the eyeball. The edge notch does not require the suture needle to pass through the hole, which can reduce the operation difficulty for the operator to suture the stent to the eyeball.

[0011] In addition, in the pressure band according to the present disclosure, optionally, the surface of the abutting portion in contact with the eyeball is a flat surface or a micro-convex surface. In this case, according to the severity of the bulging of the posterior sclera, a flat surface or a micro-convex surface can be adopted. After the pressure band is fixed to the eyeball, the surface of the abutting portion in contact with the eyeball can press against the bulging area of the posterior sclera to resist the tendency of the posterior sclera to continue to bulge, thereby being able to relieve the bulging of the posterior sclera and delay the deepening of the myopia degree.

[0012] In addition, in the pressure band according to the present disclosure, optionally, the shaping member includes at least one structure of a fixed through hole, a wavy edge, a texture or a slot. In this case, the shaping member embedded in the stent is not easily displaced.

[0013] In addition, in the pressure band involved in the present disclosure, optionally, the shaping member has a main body portion located in the strip portion and an embedding portion located in the supporting portion. In this case, it is possible to allow the bracket to twist slightly at the connection between the strip portion and the supporting portion and maintain the twisted state.

[0014] In addition, in the pressure band involved in the present disclosure, optionally, a tapered area is provided at one end of the supporting portion away from the strip portion. In this case, when the pressure band is inserted into the eyeball, the tapered area can gradually expand the narrow area after the eyeball is opened, thereby facilitating the insertion of the pressure band into the eyeball.

[0015] In addition, in the pressure band involved in the present disclosure, optionally, the main body layer is made of silicone or polyurethane with a hardness of 20 degrees to 50 degrees, and the covering layer is made of one or more of silicone sponge, silicone, collagen, acellular tissue, hydrogel, polyurethane, expanded polytetrafluoroethylene, polyacrylic acid, EVA, polyvinyl alcohol resin, polymethacrylate with a hardness of 5 degrees to 30 degrees. In this case, after the pressure band is fixed to the eyeball, if the posterior sclera of the eyeball has a tendency to continue to bulge, the harder main body layer can conduct pressure to the softer covering layer to resist the tendency of the posterior sclera to continue to bulge, thereby alleviating the continuous bulging of the posterior sclera of the eyeball, and further being able to delay the deepening of myopia; at the same time, the harder main body layer can facilitate the operator to accurately position the pressure band to the position that needs to be moved in the narrow area of the eyeball, and the hardness of the covering layer against the posterior sclera is relatively low, thereby enabling the pressure band to reduce damage to the eyeball, reduce the physical stimulation caused by implanting the pressure band, reduce the foreign body sensation, and improve the biocompatibility between the pressure band and the eyeball.

[0016] In addition, in the pressure band involved in the present disclosure, optionally, the shaping member is made of a rigid-plastic material. In this case, a shaping member with an expected shape and expected stiffness can be obtained through processing.

[0017] According to the present disclosure, it is possible to provide an extra-macular pressure band that is not easily loosened and causes less damage to the eyeball. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The present disclosure will now be further explained in detail only by way of examples with reference to the accompanying drawings, wherein:

[0019] Figure 1A is a three-dimensional schematic diagram showing the pressure band involved in the present disclosure fixed on the eyeball.

[0020] Figure 1B is a cross-sectional schematic diagram showing the pressure band involved in the present disclosure fixed on the eyeball.

[0021] Figure 2 is an exploded view showing the pressure band involved in the present disclosure.

[0022] Figure 3 It is a schematic structural diagram showing the integral molding of the main body layer and the fixing belt involved in the present disclosure.

[0023] Figure 4 It shows what is involved in the present disclosure Figure 3 front view.

[0024] Figure 5 It shows what is involved in the present disclosure Figure 4 cross-sectional view taken along A-A in [reference].

[0025] Figure 6 It is a schematic structural diagram showing that the shaping member involved in the present disclosure includes a fixing through-hole and a wavy edge.

[0026] Figure 7 It is a schematic structural diagram showing that the shaping member involved in the present disclosure includes texture and slots.

[0027] Figure 8 It is a schematic diagram showing that the bracket involved in the present disclosure has surgical markings.

[0028] Explanation of reference numerals:

[0029] 1... pressing belt, 101... through-hole, 102... semi-through-hole, 103... scale line, 104... edge notch, 105... marked line segment, 106... micro-convex mark,

[0030] 11... bracket, 12... fixing belt, 13... first fixing belt, 14... second fixing belt,

[0031] 15... shaping member, 151... main body part, 152... embedding part, 153... fixing through-hole, 154... wavy edge, 155... texture, 156... slot,

[0032] 16... main body layer, 161... strip part, 162... supporting part, 1621... tapered area, 163... placement groove, 1631... entrance area, 1632... main placement area, 1633... transverse protrusion, 1634... middle notch, 164... groove,

[0033] 17... covering layer, 171... strip part, 172... abutting part,

[0034] 2... eyeball, 21... sclera, 22... optic nerve. Detailed Description of the Preferred Embodiments

[0035] Hereinafter, with reference to the accompanying drawings, the preferred embodiments of the present disclosure will be described in detail. In the following description, the same reference numerals are given to the same components, and repeated descriptions are omitted. In addition, the drawings are only schematic diagrams, and the dimensional ratios between components or the shapes of components may be different from the actual ones.

[0036] It should be noted that the terms "including" and "having" and any variations thereof in this disclosure, such as a process, method, system, product, or device including or having a series of steps or units, do not necessarily limit to those steps or units clearly listed, but may include or have other steps or units that are not clearly listed or are inherent to these processes, methods, products, or devices.

[0037] In addition, the subheadings and the like involved in the following description of this disclosure are not intended to limit the content or scope of this disclosure, but merely serve as a reading prompt. Such subheadings should neither be understood as used to divide the content of the article, nor should the content under the subheadings be limited only within the scope of the subheadings.

[0038] The extra-macular pressure band involved in this disclosure may also be referred to as a posterior scleral reinforcement device, a posterior scleral reinforcement pressure band, etc., and is hereinafter simply referred to as the pressure band.

[0039] Figure 1A is a three-dimensional schematic diagram showing the pressure band 1 involved in this disclosure fixed to the eyeball 2. Figure 1B is a cross-sectional schematic diagram showing the pressure band 1 involved in this disclosure fixed to the eyeball 2.

[0040] See Figure 1A and Figure 1B , in some examples, the pressure band 1 may be fixed to the sclera 21 of the eyeball 2.

[0041] See Figure 1A or Figure 1B , in some examples, the pressure band 1 may include a bracket 11 and a fixing band 12 connected to the bracket 11.

[0042] See Figure 1A or Figure 1B , in some examples, the fixing band 12 may include a first fixing band 13 and a second fixing band 14.

[0043] In some examples, the fixing band 12 may be in a strip shape. In some examples, the first fixing band 13 and the second fixing band 14 may be in a strip shape. In this case, one end of the first fixing band 13 and the second fixing band 14 can be connected to the bracket 11.

[0044] In some examples, the strip shape may refer to a shape having a significant length direction and corresponding two ends in the length direction.

[0045] In some examples, the bracket 11, the first fixing band 13, and the second fixing band 14 may be sutured to the sclera 21 of the eyeball 2.

[0046] Figure 2 is an exploded view showing the pressure band 1 involved in this disclosure.

[0047] See Figure 2 , in some examples, the bracket 11 may include a shaping member 15 embedded in the bracket 11, and the shaping member 15 may provide a supporting force for the bracket 11.

[0048] In some examples, the shaping member 15 may be made of a rigid-plastic material. In some examples, the rigid-plastic material may be a metal with a certain stiffness, such as stainless steel, shape memory alloy, pure titanium, etc. In other examples, the rigid-plastic material may be an engineering plastic with high rigidity and low creep, such as polyphenylene sulfide (PPS), polyether ether ketone (PEEK), cross-linked ultra-high molecular weight polyethylene, polyamide (nylon), etc. In this case, a shaping member 15 with an expected shape and an expected stiffness can be obtained through processing.

[0049] In some examples, the expected shape may refer to a shape that can make the shaping member 15 relatively fixedly embedded in the bracket 11. For example, the shaping member 15 may include a fixed through hole 153, a wavy edge 154, a texture 155, a slot 156, etc. (described later). In this case, the shaping member 15 can be prevented from easily shifting in the bracket 11.

[0050] In some examples, the expected stiffness may refer to the stiffness required to maintain the arc of the strip portion 161 (described later) of the main body layer 16 to adapt to different eyeball shapes because the eyeball shapes of each person are different during surgery, and to prevent the arc-shaped strip portion 161 in the main body layer 16 from being easily deformed when the bracket 11 is sutured to the eyeball 2 so that the pressure band 1 is not easily loosened. In this case, it is beneficial for the operator to use the pressure band 1 for surgery.

[0051] See Figure 2 , in some examples, the bracket 11 may further include a main body layer 16 having a first hardness.

[0052] In some examples, the main body layer 16 may be integrally formed by injection molding.

[0053] In some examples, the shape of the main body layer 16 may be substantially the same as the shape of the bracket 11.

[0054] In some examples, the shaping member 15 being embedded in the bracket 11 may mean that the shaping member 11 is embedded in the main body layer 16 of the bracket 11.

[0055] See Figure 2 , in some examples, the bracket 11 may further include a covering layer 17 covering the main body layer 16 and having a second hardness and being used to abut against the posterior sclera.

[0056] In some examples, the second hardness of the covering layer 17 may not be greater than the first hardness of the main body layer 16. In this case, the main body layer 16 can be made harder and the covering layer 17 can be made softer.

[0057] In some examples, the main body layer 16 can be made of silicone or polyurethane with a hardness of 20 degrees to 50 degrees, and the covering layer 17 can be made of one or more of silicone sponge, silicone, collagen, acellular tissue, hydrogel, polyurethane, expanded polytetrafluoroethylene, polyacrylic acid, EVA, polyvinyl alcohol resin, polymethacrylate with a hardness of 5 degrees to 30 degrees. For example, the main body layer 16 can be made of silicone with a hardness of 20 degrees, and the covering layer 17 can be made of silicone with a hardness of 5 degrees; the main body layer 16 can be made of silicone with a hardness of 50 degrees, and the covering layer 17 can be made of silicone with a hardness of 30 degrees. In this case, after the pressure band 1 is fixed to the eyeball 2, if the posterior sclera of the eyeball 2 has a tendency to continue to bulge, the harder main body layer 16 can conduct pressure to the softer covering layer 17 to resist the tendency of the posterior sclera to continue to bulge, thereby alleviating the continuous bulging of the posterior sclera of the eyeball 2, and further being able to delay the deepening of myopia; at the same time, the harder main body layer 16 can facilitate the operator to accurately position the pressure band 1 to the position that needs to be moved in the narrow area of the eyeball 2, and the hardness of the covering layer 17 against the posterior sclera is relatively low, so that the pressure band 1 can reduce the damage to the eyeball 2, and can reduce the physical stimulation caused by implanting the pressure band 1, reduce the foreign body sensation, and improve the biocompatibility between the pressure band 1 and the eyeball 2.

[0058] See Figure 2 , in some examples, the main body layer 16 may include a strip portion 161. In some examples, the strip portion 161 may be arc-shaped and the arc can be adjusted, and the strip portion 161 may have plasticity. Thus, the arc of the bracket 11 can be adjusted.

[0059] In some examples, the strip portion 161 may have plasticity. Thus, the arc of the strip portion 161 can be easily adjusted.

[0060] In some examples, the strip portion 161 being arc-shaped may mean that the strip portion 161 is arc-shaped and similar to the arc of the surface of the eyeball 2. In this case, it is beneficial to implant the pressure band 1 into the eyeball 2 and suture it in place.

[0061] See Figure 2 , in some examples, the strip portion 161 may be strip-shaped.

[0062] In some examples, the arc of the strip portion 161 being adjustable may mean that the strip portion 161 is bendable, and the operator can adjust the arc of the strip portion 161 according to the actual surgical needs, for example, making the strip portion 161 match the arc of the temporal sclera 21 of the eyeball 2. In this case, it is beneficial for the operator to perform the surgery better.

[0063] In some examples, the band portion 161 can maintain the adjusted curvature due to the presence of a shaping member 15 with expected rigidity embedded in the bracket 11 .

[0064] See also Figure 2 In some examples, the main body layer 16 may further include a supporting portion 162 connected to the strip portion 161 .

[0065] See also Figure 2 In some examples, the support portion 162 may protrude a predetermined height from the surface of the strip portion 161 close to the eyeball 2 .

[0066] In some examples, the connection between the support portion 162 and the strip portion 161 may be a smooth connection. In this case, the connection between the support portion 162 and the strip portion 161 can be made more stable.

[0067] See also Figure 2 In some examples, the end of the strip portion 161 away from the support portion 162 may be rounded. In this case, damage to the eyeball 2 can be reduced.

[0068] In some examples, the width of the strip portion 161 may be no greater than the outer diameter of the support portion 162 .

[0069] See also Figure 2 In some examples, the end of the support portion 162 away from the strip portion 161 may be provided with a gradually thinning area 1621. In this case, when the compression belt 1 is inserted into the eyeball 2, the narrow area behind the eyeball 2 can be gradually opened by the gradually thinning area 1621, thereby facilitating the insertion of the compression belt 1 into the eyeball 2.

[0070] See also Figure 2 In some examples, the covering layer 17 may include a strip portion 171 covering the strip portion 161 .

[0071] See also Figure 2 In some examples, the covering layer 17 may further include abutting portion 172 covering the supporting portion 162 and used to abut against the posterior sclera of the eyeball 2. In this case, the side of the bracket 11 that fits the eyeball 2 has a lower hardness, thereby reducing the damage of the pressure belt 1 to the eyeball 2.

[0072] In some examples, the side of the abutting portion 172 that fits the eyeball 2 may be disc-shaped, polygonal, elliptical, semicircular, or approximately circular. In this case, the bracket 11 can be made more firm and stable.

[0073] In some examples, the strip portion 171 may cover the strip portion 161, and the curvature of the strip portion 161 is adjustable. Thus, the curvature of the strip portion 171 can be adjusted.

[0074] See Figure 2 , in some examples, the connection of the fixing band 12 to the bracket 11 may mean that one end of the first fixing band 13 and the second fixing band 14 are respectively connected to the supporting part 162 of the main body layer 16 relatively.

[0075] In some examples, the fixing band 12 and the main body layer 16 can be integrally formed. Thus, the pressing band 1 can be made more firm and stable.

[0076] Figure 3 is a schematic structural view showing the integral formation of the main body layer 16 and the fixing band 12 involved in the present disclosure. Figure 4 is showing what is involved in the present disclosure Figure 3 front view.

[0077] Combined with Figure 3 and Figure 4 , in some examples, the main body layer 16 may have a placement groove 163, and the placement groove 163 can be matched with the shaping member 15. In this case, the placement groove 163 can enable the shaping member 15 to be embedded in the main body layer 16, and further enable the shaping member 15 to be embedded in the bracket 11.

[0078] In some examples, the shaping member 15 may be strip-shaped.

[0079] In some examples, the shaping member 15 can be placed in the placement groove 163 along the length direction of the strip portion 161.

[0080] In some examples, the placement groove 163 can be matched with the shaping member 15 means that the shape of the placement groove 163 can be similar to the shape of the shaping member 15, and the depth of the placement groove 163 can be greater than the thickness of the shaping member 15. In this case, the shaping member 15 can be embedded in the main body layer 16.

[0081] Figure 5 is showing what is involved in the present disclosure Figure 4 cross-sectional view taken along A-A in

[0082] Combined with Figure 3 , Figure 4 and Figure 5 , in some examples, the placement groove 163 can be formed on the side of the strip portion 161 close to the eyeball 2 and extend to the edge of the supporting part 162. Thus, a part of the shaping member 15 can be placed on the strip portion 161, another part of the shaping member 15 can be placed on the supporting part 162, and when the placement groove 163 is placed with the shaping member 15, the shaping member 15 can provide a supporting force for the bracket 11.

[0083] See Figure 2, in some examples, the shaping member 15 may have a main body portion 151 located in the strip portion 161 and an embedded portion 152 located in the supporting portion 162. That is, the shaping member 15 may be partially embedded in the supporting portion 162. In this case, it is possible to allow the bracket 11 to slightly twist at the connection between the strip portion 161 and the supporting portion 162 and maintain the twisted state.

[0084] In some other examples, the placement groove 163 may be formed on the side of the strip portion 161 close to the eyeball 2 and extend to the middle area of the supporting portion 162. In this case, the overall pressing belt 1 can be made more compact.

[0085] In some other examples, the shaping member 15 may be entirely located in the strip portion 161. That is, the shaping member 15 is not embedded in the supporting portion 162. In this case, when adjusting the curvature of the strip portion 161, the shaping member 15 can provide a more uniform supporting force to the strip portion 161 of the bracket 11.

[0086] Combined Figure 3 and Figure 5 , in some examples, the main body layer 16 may further have a groove 164.

[0087] Combined Figure 3 and Figure 5 , in some examples, the groove 164 may be formed in the middle area on the side of the supporting portion 162 close to the eyeball 2.

[0088] In some examples, the bottom of the groove 164 may have a protrusion, and the overall groove 164 may be in a disc shape, a polyhedral prism shape, a semi-ellipsoidal shape, a semi-spherical shape or a near semi-spherical shape. In this case, the surface of the covering layer 17 in contact with the main body layer 16 may have a depression corresponding to the protrusion. Thus, it is possible to facilitate the formation of a physical connection between the covering layer 17 and the main body layer 16 and reduce the possibility of unreliable connection between the covering layer 17 and the main body layer 16 due to chemical connection or bonding.

[0089] In some examples, the groove 164 may be in a disc shape, a polyhedral prism shape, a semi-ellipsoidal shape, a semi-spherical shape or a near semi-spherical shape.

[0090] In some examples, the edge of the supporting portion 162 may refer to the edge other than the middle area of the supporting portion 162.

[0091] See Figure 3 , in some examples, the placement groove 163 may include an entrance area 1631 and a main placement area 1632, where the shaping member 15 may enter the main placement area 1632 through the entrance area 1631. In this case, the shaping member 15 can be embedded in the main body layer 16.

[0092] Combined Figure 3And Figure 5 In some examples, the entrance area 1631 can be located at one end of the placement groove 163 away from the support portion 162. In this case, it is convenient to place the shaping member 15 into the placement groove 163.

[0093] Combined with Figure 3 and Figure 5 In some examples, for the two sides of the main placement area 1632 parallel to the length direction of the strip portion 161 that are higher than the shaping member 15, they can respectively protrude towards the middle of the strip portion 161 to form a transverse protrusion 1633 parallel to the shaping member 15 and blocking the shaping member 15. In this case, through the transverse protrusion 1633, the shaping member 15 can be prevented from easily detaching from the placement groove 163.

[0094] Refer to Figure 3 and Figure 4 In some examples, the transverse protrusions 1633 formed on the two sides of the main placement area 1632 parallel to the length direction of the strip portion 161 may not be in contact with each other to form an intermediate gap 1634. In this case, it is beneficial to adjust the position of the shaping member 15 through the intermediate gap 1634 after placing the shaping member 15 into the placement groove 163 through the entrance area 1631, or to facilitate moving the shaping member 15 to the entrance area 1631 through the intermediate gap 1634 later to take out the shaping member 15.

[0095] In some examples, the width of the intermediate gap 1634 can be smaller than the width of the shaping member 15, that is, the vertical distance between the two transverse protrusions 1633 can be smaller than the width of the shaping member 15.

[0096] Combined with Figure 3 and Figure 5 In some examples, the intermediate gap 1634 can communicate with the groove 164.

[0097] Combined with Figure 3 and Figure 5 In some examples, the placement groove 163 can communicate with the groove 164 through the intermediate gap 1634. In some examples, after placing the shaping member 15 into the placement groove 163, a coating material can be used to coat the side of the placement groove 163 and the groove 164 close to the eyeball 2 to form a covering layer 17. In this case, since the placement groove 163 communicates with the groove 164, the strip portion 171 and the abutting portion 172 of the covering layer 17 formed by coating with the coating material are integrally connected, so that the strip portion 171 and the abutting portion 172 can have stronger connection strength.

[0098] In some examples, the coating material may refer to one or more of silicone sponge, silicone, collagen, acellular tissue, hydrogel, polyurethane, expanded polytetrafluoroethylene, polyacrylic acid, EVA, polyvinyl alcohol resin, and polymethacrylate with a hardness of 5 degrees to 30 degrees.

[0099] In some examples, the shaping member 15 cannot enter the groove 164 through the communication portion of the placement groove 163 and the groove 164. In this case, the embedding portion 152 of the shaping member 15 can be held at the edge of the supporting portion 162.

[0100] In some examples, that the shaping member 15 cannot enter the groove 164 through the communication portion of the placement groove 163 and the groove 164 may mean, for example, that the bottom surface of the placement groove 163 and the bottom surface of the groove 164 may be in different planes, and the bottom surface of the placement groove 163 and the bottom surface of the groove 164 are connected by another plane that intersects the plane where the bottom surface of the placement groove 163 is located and the plane where the bottom surface of the groove 164 is located respectively, so that the placement groove 163 and the groove 164 are connected. At this time, the shaping member 15 cannot enter the groove 164 through the communication portion of the placement groove 163 and the groove 164; for another example, the end of the placement groove 163 close to the groove 164 may gradually narrow to connect with the groove 164, and the end of the shaping member 15 close to the groove 164 may not gradually narrow. At this time, the shaping member 15 cannot enter the groove 164 through the communication portion of the placement groove 163 and the groove 164.

[0101] In other examples, the shaping member 15 can enter the groove 164 through the communication portion of the placement groove 163 and the groove 164.

[0102] In some examples, when the pressing band 1 is fixed to the eyeball 2, the abutting portion 172 can abut against the posterior scleral surface of the eyeball 2, and the fixing band 12 and the strip portion 171 can be fixed on the sclera 21 of the eyeball 2 so that the abutting portion 171 can keep abutting against the eyeball 2.

[0103] Combined Figure 1A 、 Figure 1B 、 Figure 2 and Figure 3 , in some examples, after the pressing band 1 is fixed to the eyeball 2, the abutting portion 172 can abut against the posterior sclera of the eyeball 2, such as the scleral area of the macula. The supporting portion 162 is close to the optic nerve 22 of the eyeball 2. The strip portion 161, the first fixing band 13 and the first fixing band 14 can be sutured to the sclera 21 of the eyeball 2. In this case, while the pressing band 1 is fixed to the eyeball 2 through the strip portion 161, the first fixing band 13 and the first fixing band 14, the abutting portion 172 can exert a pressing force on the eyeball 2, thereby being able to resist the tendency of the posterior sclera to continue to bulge, thus relieving the continuous bulging of the posterior sclera of the eyeball 2, and further being able to delay the deepening of myopia degree.

[0104] Figure 6 It is a schematic structural diagram showing that the shaping member 15 involved in the present disclosure includes a fixed through-hole 153 and a wavy edge 154.

[0105] Combined Figure 2 and Figure 6 In some examples, the shaping member 15 may include a fixed through-hole 153, and the fixed through-hole 153 may be a hole that penetrates the shaping member 15 along the thickness direction of the shaping member 15. Thus, when coating the side of the main body layer 16 where the shaping member 15 is placed and close to the eyeball 2 to form a covering layer 17, the covering layer 17 can pass through the fixed through-hole 153 and firmly combine with the strip portion 161, and further, the shaping member 15 embedded in the bracket 11 is not likely to shift.

[0106] In some examples, the number of the fixed through-holes 153 may be 2, 3, 4, 5, 6, 7, or 8, etc. However, the present disclosure is not limited thereto, and the number of the fixed through-holes 153 can be adaptively adjusted according to the size of the shaping member 15.

[0107] Combined Figure 2 and Figure 6 In some examples, multiple fixed through-holes 153 may be arranged in sequence along the length direction of the shaping member 15.

[0108] Combined Figure 2 and Figure 6 In some examples, the shaping member 15 may include a wavy edge 154, and the wavy edge 154 may refer to the edge of the shaping member 15 being in the shape of a wavy line. For example, the edge of a bicycle chain can be in the shape of a wavy line. Thus, when coating the side of the main body layer 16 where the shaping member 15 is placed and close to the eyeball 2 to form a covering layer 17, the covering layer 17 can closely fit with the wavy edge 154, and further, the shaping member 15 embedded in the bracket 11 is not likely to shift.

[0109] Figure 7 It is a schematic structural diagram showing that the shaping member 15 involved in the present disclosure includes a texture 155 and a slot 156.

[0110] Combined Figure 2 and Figure 7, in some examples, the shaping member 15 may include a texture 155, and the texture 155 may be located on the lower surface of the shaping member 15 that contacts the placement groove 163. In some examples, the texture 155 may be located on the upper surface of the shaping member 15 that contacts the covering layer 17. In some examples, the texture 155 may be formed by protruding a certain height on the lower surface and the upper surface of the shaping member 15 according to a preset pattern. In this case, the friction between the shaping member 15 and the main body layer 16 and the covering layer 17 can be increased, and thus the shaping member 15 embedded in the bracket 11 is not likely to shift.

[0111] Combined with Figure 2 and Figure 7 , in some examples, the shaping member 15 may include a slot 156, and the slot 156 may be formed by recessing a certain depth in the thickness direction of the shaping member 15 on the upper surface where the shaping member 15 contacts the covering layer 17. In this case, when coating the side of the main body layer 16 where the shaping member 15 is placed and close to the eyeball 2 to form the covering layer 17, the covering layer 17 can be partially embedded in the slot 156 and closely fit with the shaping member 15, and thus the shaping member 15 embedded in the bracket 11 is not likely to shift.

[0112] In some examples, the shaping member 15 may include at least one structure of a through hole 153, a wavy edge 154, a texture 155 or a slot 156. In this case, the shaping member 15 embedded in the bracket 11 is not likely to shift.

[0113] Combined with Figure 2 and Figure 3 , in some examples, the abutting portion 172 may protrude a predetermined height from the surface of the strip portion 171 close to the eyeball 2. In other words, since the supporting portion 162 may protrude a predetermined height from the surface of the strip portion 161 close to the eyeball 2, and the middle notch 1634 may communicate with the groove 164, when coating the side of the main body layer 16 where the shaping member 15 is placed and close to the eyeball 2 to form the covering layer 17, the coated abutting portion 172 may protrude a predetermined height from the surface of the coated strip portion 171 close to the eyeball 2. In this case, the protruding predetermined height can be conducive to the abutting portion 172 forming a micro-convex surface.

[0114] In some examples, that the bracket 11 is slightly twisted at the connection of the strip portion 171 and the abutting portion 172 may mean that with the connection of the strip portion 171 and the abutting portion 172 as the rotation center axis, one end of the strip portion 171 away from the abutting portion 172 makes a twist closer to or farther from the eyeball 2.

[0115] Combined with Figure 1B and Figure 2, in some examples, the thickness of the strip portion 171 can be less than the thickness of the abutting portion 172. Thus, when the abutting portion 172 presses against the bulging area of the posterior sclera, the strip portion 171 can be suspended from the bulging area of the posterior sclera, thereby enabling smooth blood supply to the eyeball 2 and facilitating the recovery of the eyeball 2 after surgery.

[0116] In some examples, the strip portion 171 being suspended from the bulging area of the posterior sclera may mean that the connection between the strip portion 171 and the abutting portion 172 does not press against the bulging area of the posterior sclera.

[0117] Combined Figure 1B and Figure 2 , in some examples, the surface of the abutting portion 172 that fits against the eyeball 2 can be a flat surface or a slightly convex surface. In this case, according to the severity of the posterior scleral bulge, a flat surface or a slightly convex surface can be used. After the pressure band 1 is fixed to the eyeball 2, the surface of the abutting portion 172 that fits against the eyeball 2 can press against the bulging area of the posterior sclera to resist the tendency of the posterior sclera to continue bulging, thereby being able to relieve the bulging condition of the posterior sclera and delay the deepening of myopia.

[0118] In some examples, according to the posterior scleral bulge conditions of different patients, the surface of the abutting portion 172 that fits against the eyeball 2 can adopt an appropriate micro-convex curvature. In this case, the surgical effect can be better.

[0119] In some examples, the fixing band 12 and the bracket 11 can include surgical marks.

[0120] Figure 8 is a schematic diagram showing that the bracket 11 involved in the present disclosure has surgical marks. It should be noted that Figure 8 the positions of the various surgical marks shown in Figure 8 are only schematic positions for convenient display. In some other examples, the positions of the various surgical marks can be not limited to

[0121] Refer to Figure 8 , in some examples, the surgical mark located on the bracket 11 can be a through hole 101. In this case, the operator can observe part of the situation of the eyeball 2 through the through hole 101, and thus the operator can find a suitable suture point on the bracket 11 and suture through the through hole 101.

[0122] In some examples, the number of through holes 101 can be 2, 3, 4, 5, 6, 7, or 8, etc. However, the present disclosure is not limited thereto, and the number of through holes 101 can be adaptively adjusted according to the size of the bracket 11.

[0123] In some examples, the through-hole 101 being located in the bracket 11 may mean that the through-hole 101 penetrates through the bracket 11 and is located at one end of the bracket 11 away from the abutting portion 172. In this case, when suturing the bracket 11 to the eyeball 2, it is sutured from the end of the bracket 11 away from the abutting portion 172 and the supporting portion 162 to the eyeball 2. Since the curvature of the strip portion 171 and the belt portion 161 is adjustable and can be maintained, the portion of the bracket 11 that is not sutured to the eyeball 2 can be adjusted in curvature so that it does not press against the eyeball 2, thereby enabling smooth blood supply to the eyeball 2 and facilitating the operator's operation on the pressing belt 1.

[0124] In some examples, multiple through-holes 101 may be evenly distributed at one end of the bracket 11 away from the abutting portion 172. In this case, when suturing the bracket 11 to the eyeball 2 through the through-holes 101 with sutures, the force on the bracket 11 can be relatively balanced.

[0125] See Figure 8 , in some examples, the surgical mark located on the bracket 11 may be a semi-through-hole 102. The semi-through-hole 102 may refer to a blind hole formed on the side of the bracket 11 close to the eyeball 2 without penetrating through the bracket 11. During the operation, the required semi-through-hole 102 can be penetrated by a sewing needle. In this case, compared with multiple through-holes 101, multiple semi-through-holes 102 can enable the bracket 11 to have greater tension, and at the same time enable the operator to have more suture methods to choose from.

[0126] See Figure 8 , in some examples, the surgical mark located on the bracket 11 may be a scale line 103. The scale line 103 may refer to a line segment marked with numbers to indicate the distance. In this case, the operator can determine the appropriate suture position through the scale line 103.

[0127] See Figure 8 , in some examples, the surgical mark located on the bracket 11 may be an edge notch 104. The edge notch 104 can be used to accommodate sutures. In some examples, the edge notch 104 may be formed on opposite sides of the edge of the belt portion 161. In this case, after the relatively arranged edge notches 104 accommodate the sutures, the sutures are not likely to slide on both sides of the belt portion 161, so that the bracket 11 can be sutured to the eyeball 2 more firmly.

[0128] In some examples, the edge notches 104 located on the bracket 11 may be relatively arranged on both sides of the belt portion 161 in the connection direction of the belt portion 161 and the supporting portion 162. Thus, the bracket 11 can be sutured to the eyeball 2 more firmly.

[0129] See Figure 8, in some examples, the surgical mark located on the stent 11 may be the marked line segment 105, and the marked line segment 105 may be a segment with suture marks or prompt marks, etc. In this case, the operator can determine the appropriate suture position of the stent 11 through the marked line segment 105.

[0130] See Figure 8 , in some examples, the surgical mark located on the stent 11 may be the micro-convex mark 106, and the micro-convex mark 106 may be micro-convexly formed on the stent 11 in a predetermined pattern or number, etc. In this case, when the observation field during the operation is poor, the operator can determine the appropriate suture position of the stent 11 by sensing the micro-convex mark 106.

[0131] In some examples, the first fixing band 13 and the first fixing band 14 may include surgical marks.

[0132] In some examples, the number of surgical marks on the fixing band 12 is at least one. In this case, the fixing band 12 with surgical marks can enable the operator to more conveniently suture the pressing band 1 to the eyeball 2.

[0133] See Figure 2 and Figure 3 , in some examples, the surgical mark located on the fixing band 12 may be the through hole 101. In this case, the operator can observe part of the situation of the eyeball 2 through the through hole 101, and then the operator can find an appropriate suture point on the fixing band 12 and suture through the through hole 101.

[0134] In some examples, the number of the through holes 101 may be 2, 3, 4, 5, 6, 7, or 8, etc. However, the present disclosure is not limited thereto, and the number of the through holes 101 can be adaptively adjusted according to the size of the fixing band 12.

[0135] See Figure 2 and Figure 3 , in some examples, multiple through holes 101 may be arranged along the length direction of the fixing band 12. In this case, when the fixing band 12 is sutured to the eyeball 2 through the through holes 101 by the suture, the force on the fixing band 12 can be relatively balanced.

[0136] Combined with Figure 2 、 Figure 3 and Figure 8, in some examples, the surgical mark located on the fixing band 12 may be a semi-through hole 102. The semi-through hole 102 may refer to a blind hole formed on the side of the fixing band 12 close to the eyeball 2 without penetrating the fixing band 12. During the operation, the required semi-through hole 102 can be penetrated by a suture needle. In this case, compared with multiple through holes 101, multiple semi-through holes 102 can enable the fixing band 12 to have greater tension, and at the same time enable the operator to have more suture methods to choose from.

[0137] Combined with Figure 2 、 Figure 3 and Figure 8 , in some examples, the surgical mark located on the fixing band 12 may be a scale line 103. In this case, the operator can determine the appropriate suture position through the scale line 103.

[0138] Combined with Figure 2 、 Figure 3 and Figure 8 , in some examples, the surgical mark located on the fixing band 12 may be an edge notch 104, and the edge notch 104 can be used to accommodate the suture. In some examples, the edge notch 104 may be formed on opposite sides in the length direction of the first fixing band 13 and the first fixing band 14. In this case, the operator can suture the first fixing band 13 and the first fixing band 14 to the eyeball 2 through the edge notch 104.

[0139] Combined with Figure 2 、 Figure 3 and Figure 8 , in some examples, the surgical mark located on the fixing band 12 may be a marked line segment 105. In this case, the operator can determine the appropriate suture position of the fixing band 12 through the marked line segment 105.

[0140] Combined with Figure 2 、 Figure 3 and Figure 8 , in some examples, the surgical mark located on the fixing band 12 may be a micro-convex mark 106, and the micro-convex mark 106 may be micro-convexly formed on the fixing band 12 in a predetermined pattern or number, etc. In this case, when the observation field of view during the operation is poor, the operator can determine the appropriate suture position of the fixing band 12 by sensing the micro-convex mark 106.

[0141] In some examples, the fixing band 12 and the bracket 11 may include surgical marks, and the surgical marks are at least one of a through hole 101, a semi-through hole 102, a scale line 103, an edge notch 104, a marked line segment 105 or a micro-protrusion mark 106. In this case, according to different surgical marks and combinations of different surgical marks, it is beneficial for the operator to operate on the pressing band 1 according to the surgical marks.

[0142] SeeFigure 2 and Figure 3 In some examples, the surgical mark located on the fixing band 12 may be a through hole 101, and the surgical mark located on the bracket 11 may be an edge notch 104. In this case, the operator can observe part of the condition of the eyeball 2 through the through hole 101, which is beneficial for the operator to suture the fixing band 12 to the eyeball 2. The edge notch 104 can reduce the operation difficulty for the operator to suture the bracket 11 to the eyeball 2 without passing the suture needle through the hole.

[0143] See Figure 2 、 Figure 3 and Figure 4 In some examples, the thickness of the first fixing band 13 and the second fixing band 14 may be less than the thickness of the supporting part 162. Specifically, taking the first fixing band 13 as an example, the supporting part 162 may protrude a predetermined height from the extension surface of the side of the first fixing band 13 close to the eyeball 2 so that the thickness of the first fixing band 13 is less than the thickness of the supporting part 162. In this case, it can be ensured that the connection parts of the first fixing band 13 and the second fixing band 14 with the abutting part 172 do not press on the bulging area of the posterior sclera, and thus the blood supply of the eyeball 2 can be unobstructed and it is beneficial for the recovery of the eyeball 2 after the operation.

[0144] See Figure 2 、 Figure 3 and Figure 4 In some examples, the width of the first fixing band 13 and the second fixing band 14 may not be greater than the outer diameter of the supporting part 162. Specifically, taking the first fixing band 13 as an example, when viewed along the extension surface of the side of the first fixing band 13 close to the eyeball 2, the width of the first fixing band 13 may not be greater than the outer diameter of the supporting part 162.

[0145] In some examples, the width of the first fixing band 13 and the second fixing band 14 may be substantially the same as the width of the strip part 161. In some examples, the thickness of the first fixing band 13 and the second fixing band 14 may be substantially the same as the thickness of the strip part 161. In some examples, the length of the first fixing band 13 and the second fixing band 14 may not be less than the length of the strip part 161. In some examples, after the first fixing band 13, the second fixing band 14 and the strip part 161 are placed horizontally, the first fixing band 13, the second fixing band 14 and the strip part 161 may be on the same horizontal plane.

[0146] See Figure 2 、 Figure 3 and Figure 4 In some examples, the ends of the first fixing band 13 and the second fixing band 14 away from the supporting part 162 may have a rounded corner transition. In this case, the damage to the eyeball 2 can be reduced.

[0147] In some examples, the connection between the support portion 162 and the first fixing band 13 and the second fixing band 14 can be a smooth connection. That is to say, the connection between the support portion 162 and the fixing band 12 can be a smooth connection. In this case, the connection between the support portion 162 and the first fixing band 13 and the second fixing band 14 can be made more stable.

[0148] Although the present disclosure has been specifically described above in conjunction with the accompanying drawings and examples, it is understood that the above description does not limit the present disclosure in any way. Those skilled in the art can make deformations and changes to the present disclosure as needed without departing from the essence and scope of the present disclosure, and these deformations and changes all fall within the scope of the present disclosure.

Claims

1. An extra-macular pressure band, which is a pressure band for fixing on the eyeball, is characterized in that it includes a bracket and a fixing band connected to the bracket, the bracket includes a shaping member embedded in the bracket, a main body layer with a first hardness, and a covering layer covering the main body layer and having a second hardness and used for abutting against the posterior sclera, the shaping member is embedded in the main body layer to provide support force for the bracket, and the second hardness is less than the first hardness, so that when there is a tendency for the posterior sclera of the eyeball to continue to bulge, the harder main body layer conducts pressure to the softer covering layer to resist the tendency of the posterior sclera to continue to bulge, thereby alleviating the continuous bulging of the posterior sclera of the eyeball. The shaping member is made of a rigid-plastic material, and the rigid-plastic material is one of stainless steel, memory alloy, pure titanium, polyphenylene sulfide, polyether ether ketone, cross-linked ultra-high molecular weight polyethylene, and polyamide; the main body layer includes an arc-shaped and adjustable-arc and plastic strip portion and a supporting portion connected to the strip portion, and the shaping member is located in the strip portion and partially embedded in the supporting portion; the covering layer includes a strip portion covering the strip portion and an abutting portion covering the supporting portion and used for abutting against the posterior sclera of the eyeball; the shaping member enables the arc of the strip portion to be maintained after adjustment; the fixing band is strip-shaped, and the fixing band is connected to the supporting portion.

2. The pressure band according to claim 1, characterized in that the abutting portion protrudes a predetermined height from the surface of the strip portion close to the eyeball.

3. The pressure band according to claim 1, characterized in that the fixing band and the bracket include surgical marks, and the surgical marks are at least one of through holes, semi-through holes, scale lines, edge notches, marked line segments, and micro-protrusion marks.

4. The pressure band according to claim 3, characterized in that the surgical mark on the fixing band is a through hole, and the surgical mark on the bracket is an edge notch.

5. The pressure band according to claim 1, characterized in that the surface of the abutting portion in contact with the eyeball is a flat surface or a slightly convex surface.

6. The pressure band according to claim 1, characterized in that the shaping member includes at least one structure of a fixing through hole, a wavy edge, a texture, and a slotted groove.

7. The pressure band according to claim 1, characterized in that the shaping member has a main body portion located in the strip portion and an embedded portion located in the supporting portion.

8. The pressure band according to claim 1, characterized in that one end of the supporting portion away from the strip portion is provided with a tapered area.

9. The pressure band according to claim 1, characterized in that the main body layer is made of silica gel or polyurethane, and the covering layer is made of one or more of silica gel sponge, silica gel, collagen, acellular tissue, hydrogel, polyurethane, expanded polytetrafluoroethylene, polyacrylic acid, EVA, polyvinyl alcohol resin, and polymethacrylate.

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