Tissue distraction device

Abstract

The invention provides a tissue distraction device which comprises an annular frame, the annular frame comprises a first part and a second part which are hinged to each other, at least one part of one of the first part and the second part is fixed in position in an axial direction, and the other one of the first part and the second part is movable in the axial direction. The annular frame can be expanded and contracted in the radial direction by driving the first part or the second part, and the annular frame is used for expanding tissue when expanded. The tissue distraction device can be applied to a surgical operation with a small operation space to help distraction of the tissue, so that the tissue does not affect the operation at a target position, and meanwhile, the operation space with a proper size is provided for a doctor.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and in particular relates to a tissue spreading device. Background Technology

[0002] Tissue surgery, to minimize trauma to the patient, is typically performed in confined surgical spaces. For example, a type of cardiac tissue surgery repairing structural diseases of the mitral or tricuspid valves involves surgically opening the atrium. After the surgeon makes an incision in the atrium, a specialist needs to use assistive instruments to open the atrial tissue to expose the mitral or tricuspid valve between the atrium and ventricle. Alternatively, the atrial tissue may be sutured at one end, with the other end either attached to a support or held firmly by hand. Because this type of surgery inherently involves limited operating space and is technically challenging, requiring a large number of medical personnel for assistance further complicates the procedure. Summary of the Invention

[0003] To address the problems existing in the prior art, the present invention provides a tissue spreading device, comprising:

[0004] A ring frame comprising a first part and a second part hinged to each other, at least a portion of one of the first part and the second part being fixed in an axial position and the other being movable in the axial direction, the ring frame being radially expanded and contracted by driving the first part or the second part, the ring frame being used to stretch tissue when expanded.

[0005] In a preferred embodiment, the system further includes a drive shaft and a tubular component that are relatively movable, the drive shaft passing through the tubular component, a first portion connected to the tubular component, and a second portion connected to the drive shaft. When one of the drive shaft and the tubular component moves relative to the other along the axial direction, one of the first portion and the second portion is fixed in one axial direction, while the other is movable in the same axial direction.

[0006] In a preferred embodiment, the first part and the second part are each annular structures, and each annular structure includes a plurality of hinged support rods. The second part is connected to the distal end of the drive shaft. When the axial distance between the distal end of the drive shaft and the fixed position of the first part in the axial direction increases, the second part causes the first part to contract in conjunction. When the axial distance between the distal end of the drive shaft and the fixed position of the first part in the axial direction decreases, the second part causes the first part to expand in conjunction.

[0007] In a preferred embodiment, the first portion has a first joint and a second joint, and the second portion has a third joint and a fourth joint. The first joint, the second joint, the third joint and the fourth joint are located on the same plane and are used to join the surface of the tissue when the annular frame expands. The first joint, the second joint, the third joint and the fourth joint each have a plurality of suture perforations for sutures to pass through in order to fix the annular frame to the tissue during the operation.

[0008] In a preferred embodiment, the annular frame further includes a plurality of first fixing members and a plurality of second fixing members. The support rods include a plurality of first support rods having a first length, a second support rod having a second length, and a third support rod having a third length, wherein the first length is the longest, and the sum of the second and third lengths is less than the first length. The first portion is formed by a plurality of first support rods sequentially hinged to the first and second fixing members. The second portion includes a plurality of first support rods, two second support rods, and two third support rods. The plurality of first support rods in the second portion are sequentially hinged to the first or second fixing members, and their middle portions are respectively hinged to one of the first support rods in the first portion. One end of each of the two second support rods in the second portion is respectively hinged to the same second fixing member with an adjacent first support rod, and the other end is respectively hinged to the inner side of one of the first support rods in the first portion. One end of each of the two third support rods in the second portion serves as an end point and is hinged to the same second fixing member, and the other end is respectively hinged to the outer side of one of the first support rods in the first portion, and is located at the same hinge point as the second support rod.

[0009] In a preferred embodiment, the first fastener has four parts, and the first joint, the second joint, the third joint and the fourth joint are each integrally formed with one of the first fasteners.

[0010] In a preferred embodiment, the plane containing the first joint, the second joint, the third joint, and the fourth joint is located at the proximal end of the annular frame, and when the annular frame expands, there is an opening between any two adjacent first fasteners, or between any two adjacent second fasteners, or between any two adjacent first fasteners and second fasteners.

[0011] In a preferred embodiment, a locking assembly is further included to lock the annular frame at the desired expansion size. The locking assembly includes a connecting seat and a locking member. The connecting seat is hollow and fixed to the tubular member. The drive shaft passes through the connecting seat and then through the tubular member for axial movement. The locking member enters the connecting seat from the outside and can selectively contact or disengage from the drive shaft to lock or unlock it.

[0012] In a preferred embodiment, the first part is fixed to the tube body by a first connecting seat, and the second part is fixed to the drive shaft by a second connecting seat. A limiting sleeve is fixed on the second connecting seat. When the drive shaft moves, when the limiting sleeve contacts the first connecting seat, the axial distance between the second part and the first part at the fixed position in the axial direction reaches its minimum, and at this time the annular frame expands to its maximum extent.

[0013] In a preferred embodiment, the locking element is a screw, and the tissue spreading device further includes a gripping assembly having an operating lever that extends into the connecting seat and is detachably connected to the drive shaft.

[0014] In a preferred embodiment, the height of the annular frame when it expands is between 15mm and 25mm, and the maximum size of the annular frame in the radial plane after it expands to its maximum extent does not exceed 80mm.

[0015] The tissue retraction device provided by this invention can be applied in surgical procedures with limited operating space to help retract tissue, ensuring that the tissue does not interfere with the surgical position, while providing the surgeon with a suitable operating space. The annular frame comprises a first part and a second part that are hinged together, with at least a portion of one of the first and second parts fixed in one axial direction and the other movable in that direction. Thus, by driving the first or second part, the entire annular frame can expand and contract radially. When expanding, the annular frame can be used to retract the tissue. The tissue retraction device of this invention requires no control wire, has a simple instrument design, and is easy for surgeons to operate. Attached Figure Description

[0016] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly described below. Obviously, the drawings described below are merely some implementation methods provided by the embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1This is a schematic diagram of the contracted state of the tissue spreading device provided in an embodiment of the present invention.

[0018] Figure 2 yes Figure 1 A schematic diagram of an expanded state of the tissue-spreading device.

[0019] Figure 3 yes Figure 1 A schematic diagram of another expanded state of the tissue-spreading device.

[0020] Figure 4 yes Figure 3 A schematic diagram of the structure of the first fixing member of the tissue spreading device.

[0021] Figure 5 yes Figure 4 A structural schematic diagram of the first fastener from another angle.

[0022] Figure 6 yes Figure 3 A schematic diagram of the structure of the second fixing component of the tissue spreading device.

[0023] Figure 7 yes Figure 3 A partial schematic diagram of the connection points of the first, second, and third supports of the tissue spreading device.

[0024] Figure 8 This is a perspective view of a locking assembly provided in an embodiment of the present invention.

[0025] Figure 9 This is a partial cross-sectional view of the locking assembly and drive shaft provided in an embodiment of the present invention.

[0026] Figure 10 This is a schematic diagram showing the state in which the gripping component is detached from the drive shaft, as provided in an embodiment of the present invention.

[0027] Figure 11 This is a schematic diagram of a tissue spreading device provided in an embodiment of the present invention being inserted into an atrial surgical incision in a contracted state.

[0028] Figure 12 for Figure 11 A schematic diagram of the tissue opening device that expands the annular frame of the tissue opening device to open the tissue of the atrium surgical incision. Detailed Implementation

[0029] The technical solutions of the present invention will now be clearly and completely described with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0030] The following descriptions of the embodiments are made with reference to the accompanying illustrations, illustrating specific embodiments in which the invention can be implemented. Directional terms used in the description of the invention, such as "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and "sidewall," are merely for the purpose of better and clearer explanation and understanding of the invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention.

[0031] In the description of this invention, terms such as "first," "second," "third," and "fourth" are used only to distinguish the objects being described and do not have any sequential or technical meaning.

[0032] In the description of this invention, the terms "connection" and "linkage" as used herein, unless otherwise specified, include both direct connection (linkage) and indirect connection (linkage).

[0033] In the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator. The direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object (perpendicular to the axis and also perpendicular to the cross-sectional radius); the radial direction refers to the direction along the diameter or radius. It is important to note that the term "end" appearing in terms such as "proximal end," "distal end," "one end," "the other end," "first end," "second end," "initial end," "end point," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, end point, or end face, but also includes a portion extending axially and / or radially from the tip, end point, or end face on the element to which the tip, end point, or end face belongs. The above definitions are for convenience only and should not be construed as limiting the invention.

[0034] Please see Figures 1 to 3This invention provides a tissue retraction device 100, which can be widely used to retract tissue during surgery, especially suitable for use in surgical procedures to facilitate related surgeries at target surgical sites. The tissue retraction device 100 includes an annular frame 20 for retracting tissue. The annular frame 20 includes a first portion 22 and a second portion 24 hinged together. At least a portion of one of the first portion 22 and the second portion 24 is fixed in a axial direction, while the other is movable in the same axial direction. By driving the first portion 22 or the second portion 24, the annular frame 20 can expand and contract radially.

[0035] The aforementioned radial direction refers to a direction perpendicular to an axial direction. In this embodiment, it also includes a drive shaft 10 and a tubular component 322. The drive shaft 10 and the tubular component 322 are movable relative to each other, therefore the axial direction is defined as the extension direction of the drive shaft 10 and the tubular component 322. The drive shaft 10 passes through the tubular component 322 and extends out of the tubular component 322. One of the first portion 22 and the second portion 24 is fixed to the drive shaft 10, and the other is fixed to the tubular component 322. In this embodiment, the example of the first portion 22 being fixed to the tubular component 322 and the second portion 24 being fixed to the drive shaft 10 will be used for explanation.

[0036] Specifically, the first part 22 and the second part 24 of the annular frame 20 are both polygonal annular structures, and each annular structure includes multiple hinged support rods 202. The first part 22 and the second annular structure 24 also include multiple first fasteners 204a and multiple second fasteners 204b for providing hinged positions, i.e., serving as hinged members or part of hinged members. The number and length of the support rods 202 can be designed according to the requirements of the operating space during surgery.

[0037] Please refer to the following: Figure 2-3 and Figure 7 In this embodiment, the support rods 202 of the first part 22 include six first support rods 202a of a first length, which are sequentially hinged to a first fixing member 204a or a second fixing member 204b to form a hexagonal structure. The support rods 202 of the second part 24 include four first support rods 202a, two second support rods 202b of a second length, and two third support rods 202c of a third length. The first length is the longest, and the sum of the second and third lengths is less than the first length. Preferably, the third length is the shortest, less than half of the first length, and the second length is half of the first length.

[0038] The four first support rods 202a of the second part 24 are sequentially hinged to the first fixing member 204a or the second fixing member 204b, and their middle portions are respectively hinged to one of the first support rods 202a of the first part 22 via pins 209. One end of each of the two second support rods 202b of the second part 24 is respectively hinged to the same second fixing member 204b with the adjacent first support rod 202a, and the other end is respectively hinged to the inner side of one of the first support rods 202a of the first part 22 via pins 209. One end of each of the two third support rods 202c of the second part 22 serves as an end point 2020 and is hinged to the same second fixing member 204b, and the other end is respectively hinged to the outer side of one of the first support rods 202a of the first part 22 via pins 209, and is located at the same hinge point as the second support rod 202b.

[0039] One end of each of the two aforementioned third support rods 202c is located at the same hinge point as one end of a corresponding second support rod 202b, such that the third support rod 202c is substantially located on the extension line of the second support rod 202b. This same hinge point can use the same pin, which passes through the inner and outer sides of one of the first support rods 202a in the first part 22 to hinge both the third support rod 202c and the second support rod 202b.

[0040] The aforementioned third support rod 202c is basically located on the extension line of the second support rod 202b, so that the pair of third support rods 202c and second support rods 202b are combined to form a side, and thus the second ring structure 24 is also basically a hexagonal structure.

[0041] Because the first annular structure 22 and the second annular structure 24 intersect, a total of six vertices are formed at the proximal end of the entire annular frame 20, and six vertices are also formed at the distal end of the annular frame 20. In this embodiment, there are four first fixing members 204a and eight second fixing members 204b. The four first fixing members 204a and two second fixing members 204b are located at the proximal end of the annular frame 20, and the distal end of the annular frame 20 consists entirely of second fixing members 204b. When the annular frame expands, a hollow opening 210a is formed between any two adjacent first fixing members 204a, or between any two adjacent second fixing members 204b, or between any two adjacent first fixing members 204a and second fixing members 204b, thereby forming multiple such openings 210a at the proximal end, distal end, or middle of the annular frame 20. Since the opening 210a at the proximal end of the annular frame 20 is not obstructed by fixing members, it is equivalent to expanding the surgical operating space with the same expansion area.

[0042] Each of the first fixing members 204a and the second fixing member 204b has two hinge points, each with a pin. These hinge points are connected by pins, allowing each support rod 202 to rotate around its respective first fixing member 204a or second fixing member 204b. Each of the two hinge points 205a and 205b of the first fixing member 204a and the second fixing member 204b allows the two support rods 202 to rotate independently on the first fixing member 204a or the second fixing member 204b without interference. The two support rods 202 can be hinged from either the front or back of the first fixing member 204a or the second fixing member 204b, using pins for hinge connection. Furthermore, the two hinged support rods 202 can be pushed or pulled together through their central hinges, causing the entire annular frame 20 to expand or contract in tandem.

[0043] With the above arrangement, the second part 24 and the first part 22 are intertwined. A part of the second part 24 is higher than the first part 22, and a part is lower than the first part 22, so that the entire ring frame 20 is a three-dimensional structure. When the three-dimensional ring frame 20 is expanded, it can fit into the tissue incision with a certain thickness, and the ring frame 20 can be used to expand the tissue from the periphery from the distal end to the proximal end.

[0044] Please refer to the following: Figures 4 to 6 The first part 22 is provided with a first joint 206a and a second joint 206b, and the second part 24 is provided with a third joint 206c and a fourth joint 206d. The first joint 206a, the second joint 206b, the third joint 206c, and the fourth joint 206d are located on the same plane L (see [reference]). Figure 3 (), used to engage with tissue when the annular frame 20 expands, for example in cardiac surgery, engaging with atrial tissue supported by an incision.

[0045] In this embodiment, the first joint portion 206a, the second joint portion 206b, the third joint portion 206c, and the fourth joint portion 206d are integrally formed with the first fixing member 204a. Figure 4 and Figure 5 Taking only the first joint 206a as an example, the other joints have the same structure as the first joint 206a. The first joint 206a, the second joint 206b, the third joint 206c, and the fourth joint 206d extend radially outward from the first fastener 204a, so that the first joint 206a, the second joint 206b, the third joint 206c, and the fourth joint 206d can form outwardly protruding bosses that abut against the tissue surface.

[0046] The first joint 206a, the second joint 206b, the third joint 206c and the fourth joint 206d are respectively combined with a first fastener 204a to form a whole, so that the combined component serves as both a hinge component and a tissue anchoring component.

[0047] The first joint 206a, the second joint 206b, the third joint 206c and the fourth joint 206d are each provided with a suture hole 208, through which the suture for the surgical instrument is passed to suture the annular frame 20 to the tissue, so as to fix the annular frame 20 to the tissue during the operation and to stably open the tissue.

[0048] In this invention, because the lengths of the second support rod 202b and the third support rod 202c of the second annular structure 24 are relatively short, the annular frame 20 is in both the expanded and contracted states, and the end point 2020 of the third support rod 202c (see...) Figure 1 The second fastener 204b is lower than the first fastener 204a, that is, lower than the plane containing the first joint 206a, the second joint 206b, the third joint 206c, and the fourth joint 206d, so that a lower opening 210 is formed between the end point 2020 of the third support rod 202c and the hinged second fastener 204b (see...). Figure 1 This reduces the obstruction of the surgical space by the first joint 206a, the second joint 206b, the third joint 206c, and the fourth joint 206d, and the opening 210 effectively expands the surgical operating space.

[0049] In this invention, since the first part 22 and the second part 24 of the annular frame 20 are hinged to each other and can move relative to each other, that is, when at least a part of one of them is fixed in a position in an axial direction, the other can move in the same axial direction, so that when one of the first part 22 and the second part 24 moves, the other will move in conjunction, so that the entire annular frame 20 can be pushed to expand or pulled to contract.

[0050] For a better illustration of the expansion and contraction of the aforementioned annular frame 20, please refer to [link / reference needed]. Figures 8 to 9In this embodiment, the starting end 2021 of the first portion 22 is the portion fixed in the axial direction as described above, and it is connected to the tube body 322. The second portion 24 is the portion connected to the drive shaft 10 as described above, and it is connected to the distal end of the drive shaft 10. In other embodiments, since there is a gap between the drive shaft 10 and the tube body 322, they can move relative to each other. The doctor can drive the drive shaft 10 or drive the tube body 322. Therefore, the first portion 22 and the second portion 24 can move relative to each other, and when one of them moves, the other is fixed in the axial direction, i.e., the starting end of the first portion 22 or the second portion 24 (see...). Figure 3 The 2021 or 2022 model has not been moved axially, meaning that at least a portion of it remains fixed in its axial position.

[0051] The annular frame 20 can be directly expanded to its maximum extent. Preferably, to adapt to the needs of different surgical spaces, the annular frame 20 can be expanded to different states (e.g., Figure 2 and Figure 3 (Different states), and temporarily locks that state, therefore the present invention introduces a locking component 30.

[0052] One end of each of the two first support rods 202a of the first part 22 serves as the starting end 2021 of the first part 22, and is hinged to two hinge points of a second fixing member 204b, which is fixed to the tube body 322. One end of each of the two first support rods 202a of the second part 24 serves as the starting end 2022 of the second part 24, and is hinged to two hinge points of a second fixing member 204b, which is fixed to the distal end of the drive shaft 10.

[0053] Specifically, the locking assembly 30 includes a connecting seat 32 and a locking member 34. The connecting seat 32 is hollow and fixed to the proximal end of the tubular member 322. The drive shaft 10 passes through the connecting seat 32, then through the tubular member 322 for axial movement, and extends out of the tubular member 322. A second annular structure 24 is connected to the distal end of the drive shaft 10 away from the tubular member 322. The locking member 34 enters the connecting seat 32 from the outside and contacts or separates from the drive shaft 10 to lock or unlock the drive shaft 10.

[0054] The locking element 34 can be a screw that passes through the connecting seat 32 from the outside. When the locking element is loosened, the drive shaft 10 can move axially in the connecting seat 32. When the drive shaft 10 is pushed to the distal end, it causes the axial distance between the fixed position of the second annular structure 24 and the first annular structure 22 to increase. At this time, the distance between the starting end 2022 of the second annular structure 24 and the starting end 2021 of the first annular structure 22 increases, causing the first support rod 202a of the second annular structure 24 to tend to stand up, so that the entire annular structure 20 contracts to its minimum state. When the drive shaft 10 is pulled back to its proximal end, it causes the axial distance between the second annular structure 24 and the fixed position of the first annular structure 22 to decrease. During this process, as the distance between the starting end 2022 of the second annular structure 24 and the starting end 2021 of the first annular structure 22 decreases, the first support rod 202a of the second annular structure 24 causes the first support rod 202a of the first annular structure 22 to unfold. When the axial distance between the starting ends 2021 and 2022 is at its minimum, the included angle A of the support rods corresponding to this axial direction (see...) Figure 3 The complementary angle B (see also) reaches its minimum. Figure 3 Then it reaches its maximum, that is, the two first support rods 202a that are hinged to each other open to the maximum extent in a scissor-like manner, that is, the entire ring frame 20 opens to the maximum extent.

[0055] Please refer to it again. Figure 2 and Figure 3 The annular frame 20 of the present invention has different heights from its upper to lower surface in different expansion states, thus making it suitable for use in tissues of different thicknesses, utilizing the outer side of the annular frame 20 to expand the tissue. The height of the annular frame 20 is at its minimum when it is expanded to its maximum extent. The height of the annular frame 20 in different expansion states ranges from 15mm to 25mm, and at its maximum expansion, the height is approximately 15mm.

[0056] Please refer to it again. Figure 9 In this invention, a limiting component is designed to control the opening size of the annular structure 20. Specifically, the first part 22 is fixed to the tube body 322 via a first connecting seat 36a, and the second part 24 is fixed to the drive shaft 10 via a second connecting seat 36b. A limiting sleeve 36c is fixed on the second connecting seat 36b. When the drive shaft 10 moves, when the limiting sleeve 36c contacts the first connecting seat 36a, the axial distance between the second part 24 and the first part 22 at the fixed position in the axial direction reaches its minimum, and at this time, the annular frame 20 expands to its maximum extent (see...). Figure 3 ).

[0057] In surgical procedures, such as cardiac surgery, the normal mitral valve orifice size is an average width of 23.6 mm and an average length of 31.7 mm. After a diseased mitral valve, both the length and width of the orifice increase by 0-30%. The expanded size of the tissue retractor 100 needs to be larger than this mitral valve orifice to allow for the relevant surgery. Sufficient surgical space must also be provided for the surgeon's manipulation. Surgeries on cardiac tissue, such as mitral valve annulus repair, typically require sutures around the valve orifice. This necessitates adding 15-25 mm of space circumferentially to the atrial tissue above the mitral valve orifice. However, a larger expansion range of the tissue retractor 100 results in greater tissue damage. Therefore, considering all factors, the maximum width of the expanded tissue retractor 100 should not exceed 80 mm, and its height should be approximately 20 mm, to ensure it fits snugly against the cut atrial wall during cardiac surgery.

[0058] In this embodiment, the tubular component 322 may have a certain length and may be integrally formed with the connecting seat 32, or separately formed and then fixed to the connecting seat 32. In some embodiments, the tubular component 322 may be considered as part of the locking assembly 30. The first portion 22 is fixed to the distal end of the tubular component 322. The locking member 34 penetrates the connecting seat 32 from the outside to contact or separate from the drive shaft 10.

[0059] Please refer to the following: Figure 1 and Figure 10 To facilitate operation by doctors, the tissue retractor 100 of the present invention further includes a gripping assembly 40 detachably connected to the proximal end of the locking assembly 30. The gripping assembly 40 has an operating lever 41 detachably connected to the drive shaft 10, and a gripping handle 42 located proximal to the operating lever 41 for easy gripping by doctors. This detachable connection can be achieved through a detachable connection structure 43, such as an S-shaped snap or a threaded connection. After the locking member 34 is loosened, the doctor can push or pull the operating lever 41 to move the drive shaft 10 axially. After the locking member 34 is tightened, the tissue retractor 100 is locked.

[0060] It should be noted that, due to the gap between the drive shaft 10 and the tube body 322 in this invention, and because it is operated by the doctor's hand, the doctor can choose to hold the drive shaft 10 or the grip assembly 40 connected to the drive shaft 10 to push or pull the drive shaft 10 relative to the tube body 322. Alternatively, the doctor can hold the tube body 322 or the connecting seat 32 connected to the tube body 322 and move it axially relative to the drive shaft 10. This allows at least a portion of one of the first part 22 and the second part 24 to be fixed in one axial direction, while the other part is movable in the same axial direction. Both methods can achieve linkage between the first part 22 and the second part 24, causing the entire annular frame 20 to expand or contract. Generally, it is more convenient to drive the drive shaft 10 relative to the tube body 322 by holding the grip assembly 40.

[0061] Please refer to the following: Figure 3 , Figure 11 and Figure 12 Taking the surgical repair of the mitral valve as an example, an incision is made in the chest cavity, and a surgical incision is made in the atrium 200 to expose the mitral valve 300 between the atrium and ventricle. Then, the distal end of the contracted tissue expander 100 is inserted into the atrial incision. The first joint 206a, the second joint 206b, the third joint 206c, and the fourth joint 206d can be aligned with the incision surface of the atrial tissue 250 at their proximal ends. At this time, the surgeon can loosen the locking member 34 and pull the drive shaft 10 proximally to expand the annular frame 20. When the annular frame 20 reaches the ideal size, the surgeon can tighten the locking member 34 to fix the size of the annular frame 20, thereby expanding the atrial tissue 250 around the entire annular frame 20.

[0062] Because the operating space for mitral valve surgery is limited and the operating lever 41 of the grip assembly 40 is relatively long, it may hinder the entry of surgical instruments. Therefore, after the annular frame 20 is expanded to the ideal size and the locking member 34 is locked, the surgeon can rotate the grip assembly 40 to disengage the operating lever 41 from the drive shaft 10. Then, surgical instruments, such as suture needles, can be inserted through the surgical incision to temporarily fix the annular frame 20 to the atrial tissue 250. During suture preparation, sutures can be threaded through the suture holes 208 of the first joint 206a, the second joint 206b, the third joint 206c, and the fourth joint 206d to temporarily fix the annular frame 20 to the atrial tissue 250. This allows the tissue expansion device 100 to stably expand the atrial tissue 250, and surgery on the mitral valve 300 below the atrium 200 can then begin. A typical mitral valve surgery involves placing a mending annulus to repair the mitral valve annulus.

[0063] After the mitral valve surgery, the doctor can cut the sutures and directly grasp the connector 32 of the locking assembly 30 to remove the entire tissue-opening device 100.

[0064] In summary, the tissue spreading device 100 of the present invention is used to spread tissue, expand the surgical operating space, and prevent the tissue from affecting the position to be operated on. The axial movement of the drive shaft 10 allows the annular frame 20 to expand or contract, eliminating the need for additional control wires to control expansion or contraction. The annular frame 20 consists only of support rods and hinged components, simplifying the instrument and making it easy for doctors to operate. Furthermore, the support rods of the annular frame 20 do not need to be deformable and can be made of hard metals such as stainless steel.

[0065] The tissue stretching device 100 of the present invention is used as an auxiliary instrument in surgical procedures to stretch tissues, including suturing or other repair procedures.

[0066] The above are some embodiments of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A tissue spreading device, comprising: The annular frame comprises a first part and a second part hingedly connected to each other, at least one of the first part and the second part is fixed in position in an axial direction, the other is movable in the axial direction, the annular frame is expanded and contracted in the radial direction by driving the first part or the second part, and the annular frame is used to expand tissue when expanded. The annular frame further comprises a driving shaft and a tube member relatively movable, the driving shaft passes through the tube member, the first part is connected to the tube member, the second part is connected to the driving shaft, and when one of the driving shaft and the tube member moves relative to the other in the axial direction, at least one of the first part and the second part is fixed in position in an axial direction, the other is movable in the axial direction.

2. The tissue spreading device of claim 1, wherein, The first part and the second part are annular structures, and each of the annular structures comprises a plurality of hingedly connected struts, the second part is connected to the distal end of the driving shaft, and when the axial distance between the distal end of the driving shaft and the fixed position of the first part in the axial direction increases, the second part drives the first part to contract in linkage; when the axial distance between the distal end of the driving shaft and the fixed position of the first part in the axial direction decreases, the second part drives the first part to expand in linkage.

3. The tissue spreading device of claim 2, wherein, The first part has a first joint, a second joint, the second part has a third joint, and a fourth joint, the first joint, the second joint, the third joint, and the fourth joint are located in the same plane, used to engage the surface of the tissue when the annular frame is expanded, and the first joint, the second joint, the third joint, and the fourth joint respectively have a plurality of suture perforations for suture to pass through to fix the annular frame to the tissue during the operation.

4. The tissue spreading device of claim 3, wherein the tissue spreading device is configured to be used in conjunction with a tissue stapling device. The annular frame further comprises a plurality of first fixing members and a plurality of second fixing members, the struts comprise a plurality of first struts having a first length, a plurality of second struts having a second length, and a plurality of third struts having a third length, the first length is the longest, and the sum of the second length and the third length is less than the first length; 5. The tissue spreading device of claim 4, wherein, The first part is formed by a plurality of the first struts hingedly connected in sequence at the first fixing members or the second fixing members; The second part comprises a plurality of the first struts, two second struts, and two third struts, the plurality of the first struts of the second part are hingedly connected in sequence at the first fixing members or the second fixing members, and the middle parts are respectively hingedly connected to one of the first struts of the first part, one end of the two second struts of the second part is hingedly connected to the same second fixing member with the adjacent first struts, and the other end is hingedly connected to the inner side of one of the first struts of the first part; one end of the two third struts of the second part is respectively an end point, and is hingedly connected to the same second fixing member, and the other end is hingedly connected to the outer side of one of the first struts of the first part, and is located at the same hinged connection point with the second struts. ​ 6. The tissue-penetrating device of claim 5, wherein the tissue-penetrating device is configured to be inserted into the tissue at an angle of about 45 degrees to the surface of the tissue. The first fixing member has four, the first joint, second joint, third joint and fourth joint are respectively integrated with the first fixing member.

7. The tissue-papation device of claim 5, wherein the tissue-papation device is configured to be inserted into a patient's body through a small incision. The plane where the first joint, second joint, third joint and fourth joint are located is at the proximal end of the ring-shaped frame, and when the ring-shaped frame expands, there is an opening between any two adjacent first fixing members, or between any two adjacent second fixing members, or between any two adjacent first fixing members and second fixing members.

8. The tissue spreading device of claim 2, wherein, The locking assembly is also included to lock the ring-shaped frame at the desired expanded size, the locking assembly includes a connecting seat and a locking member, the connecting seat is hollow and fixed to the pipe body, the drive shaft passes through the connecting seat and then passes through the pipe body for axial movement, the locking member is inserted into the connecting seat from the outside and can be selectively in contact or separated from the drive shaft for locking or unlocking the drive shaft.

9. The tissue-papation device of claim 8, wherein The first part is fixed to the pipe body through a first connecting seat, the second part is fixed to the drive shaft through a second connecting seat, a limiting sleeve is fixed on the second connecting seat, when the drive shaft moves, the axial distance of the second part relative to the fixed position of the first part reaches the minimum when the limiting sleeve contacts the first connecting seat, and at this time the ring-shaped frame expands to the maximum extent.

10. The tissue-papation device of claim 8, wherein the tissue-papation device is configured to be inserted into a patient's body through a small incision. The locking member is a sheep horn screw, the tissue expansion device further includes a holding assembly, the holding assembly has an operating rod, the operating rod extends into the connecting seat and is detachably connected to the drive shaft.

11. The tissue-papation device of claim 1 wherein, The height of the ring-shaped frame when expanded is between 15mm-25mm, and the maximum width dimension of the ring-shaped frame in the radial plane after expanding to the maximum extent does not exceed 80mm.

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