A card-locking medical device and its use method

Abstract

The present invention discloses a clamping and locking medical device and a method for using the same, comprising: a first connecting element, one end of which has a clamping portion and the other end of which has a clamping component extending axially; a second connecting element, a side wall of which is provided with a connecting device connected to the first connecting element; an inner hole is provided at its axis; a rod, the rod passes through the second connecting element and the clamping component in sequence and is connected to the first connecting element; the rod pulls the first connecting element to move forward and backward to adjust the clamping angle, and after the human tissue is clamped in place, the clamping component is released to fix the angle of the clamping portion, and then the rod is released to complete the clamping. The present invention can quickly clamp human tissue, improve surgical efficiency, and is easy to operate; it also avoids the problem of overall rotation of the device caused by the use of a threaded rotation adjustment method; the newly designed clamping structure is adopted to reduce the axial size of the device, reduce the weight of the medical device, the patient's load, and the postoperative risk.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a card-locked medical device and a use method thereof. Background Art

[0002] Implantable devices are small in size and light in weight, and usually need to remain in the body after surgery. For heart repair or treatment surgery, the quality requirements for such devices are particularly high. Due to the small size of the device, the fixed structure of the implantable device in the prior art is often complex, large in size, inconvenient to operate, and has problems such as low surgical efficiency. Figure 1 The medical device of the prior art shown in the figure realizes the opening and closing of the clamping arm by rotating the driving screw. After the device clamps the tissue, the clamping arm is locked by the self-locking property of the thread. However, when operating this medical device, a large driving force is required to drive the screw to move, which will cause the medical device to rotate due to the torsional force and torque, which is not conducive to the operation. At the same time, since the rotation of the screw requires a large stroke in the axial direction, the ineffective distance of the device is increased, resulting in a larger size of the medical device. Therefore, it is urgent to provide a new medical device to solve at least one of the above-mentioned problems existing in the prior art. Summary of the invention

[0003] In order to overcome the above problems, the present invention provides a clamping and locking medical device and a method of using the same. The device can quickly clamp human tissue, improve surgical efficiency, and is easy to operate. It also avoids the problem of device rotation caused by the use of a threaded rotation adjustment method. The newly designed clamping structure reduces the axial size of the device, reduces the weight of the medical device, the patient's load, and the postoperative risk.

[0004] To achieve the above object, according to one aspect of an embodiment of the present invention, a card-locking medical device is provided, comprising:

[0005] A first connecting element, having a clamping portion at one end and a clamping component extending in the axial direction at the other end;

[0006] A second connecting element, whose side wall is provided with a connecting device connected to the first connecting element; and an inner hole is provided at its axis;

[0007] A rod member, the rod member sequentially passes through the second connecting element and the clamping component to be connected with the first connecting element;

[0008] The rod pulls the first connecting element to move forward and backward to adjust the clamping angle. After the human tissue is clamped in place, the clamping component is released to fix the angle of the clamping part, and then the rod is released to complete the clamping.

[0009] Optionally, the first connecting element is a clamping arm base; the clamping component is provided at a position close to the second connecting element; the clamping arm base is provided with an inner hole, and a connecting component detachably connected to the rod is provided at a position close to the clamping portion of the inner hole.

[0010] Optionally, the clamping portion further comprises at least two clamping arms, a middle portion of the clamping arm is pivotally connected to one end of the connecting device, and one end of the clamping arm is pivotally connected to a clamping arm base.

[0011] Optionally, the detachably connected connecting component is a threaded structure.

[0012] Optionally, the second connecting element is a rotating arm base, a side surface of the rotating arm base is pivotally connected to one end of the connecting device, and the other end of the connecting device is pivotally connected to the clamping portion.

[0013] Optionally, the connecting device comprises at least two rotating arms.

[0014] Optionally, the clamping component includes a card; the inner surface of the card is a smooth surface, and the outer surface is a toothed structure, and the card is arranged along the circumference of the inner hole of the first connecting element; a boss is arranged on the inner hole surface of the second connecting element; when the clamping component is released, the card returns to its original state so that the toothed structure engages with the boss.

[0015] Optionally, the card consists of at least two pieces and is made of shape memory material.

[0016] Optionally, a disengagement device is further included, which is a tubular object and is arranged between the clamping component and the second connecting element to constrain the shape of the clamping component.

[0017] According to a second aspect of an embodiment of the present invention, a method for using a medical device with a snap-on lock is provided, wherein the operating method is used to operate any one of items 1 to 8 of the first aspect; comprising:

[0018] Driving the rod to drive the first connecting element to move axially, thereby adjusting the angle of the clamping portion to clamp human tissue;

[0019] When the clamping portion reaches the target clamping angle, the clamping component is released to engage the first connecting element with the second connecting element, thereby fixing the target clamping angle;

[0020] The rod is released to disengage the rod from the first connecting element, thereby completing the clamping.

[0021] According to a third aspect of an embodiment of the present invention, a method for using a card-locked medical device is provided, wherein the operating method is used to operate the medical device described in item 9 of the first aspect; comprising:

[0022] Driving the rod to drive the first connecting element to move axially, thereby adjusting the angle of the clamping portion to clamp human tissue;

[0023] When the clamping portion reaches the target clamping angle, the clamping component is released to engage the first connecting element with the second connecting element, thereby fixing the target clamping angle;

[0024] The rod is released to disengage the rod from the first connecting element, thereby completing the clamping.

[0025] Optionally, the releasing of the clamping component in the third aspect includes withdrawing the tubular object provided between the clamping component and the second connecting element to release the shape constraint on the clamping component.

[0026] Optionally, the clamping component in the third aspect includes a card; the inner surface of the card is a smooth surface, and the outer surface is a toothed structure, and the card is arranged along the circumference of the inner hole of the first connecting element; a boss is arranged on the inner hole surface of the second connecting element; when the clamping component is released, the card returns to its original state so that the toothed structure engages with the boss.

[0027] Optionally, the card in the third aspect is at least two pieces and is made of shape memory material.

[0028] The technical solution of the present invention has the following advantages or beneficial effects:

[0029] (1) The present invention adjusts the clamping angle by pulling the first connecting element forward and backward through a rod, which can not only quickly clamp human tissue, improve surgical efficiency, and simplify operation; it also avoids the problem of medical device rotation caused by the use of a threaded rotation adjustment method, thereby improving the accuracy of human tissue clamping.

[0030] (2) The present invention releases the clamping component to fix the angle of the clamping portion only after the human tissue is clamped in place; thus avoiding the problem of the existing thread locking method that the thread is always in a locked state due to the self-locking of the thread, which increases the operating force and makes the surgery difficult.

[0031] (3) The clamping component of the present invention has a card and a boss, adopts this newly designed clamping structure, and utilizes the deformation tendency of the card to return to its original shape, so that the tooth-like feature locks the instrument, reduces the axial size of the clamping instrument, reduces the weight of the medical device, and reduces the patient's burden and postoperative risks. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation of the present invention.

[0033] Figure 1 is a schematic diagram of a prior art medical device;

[0034] Figure 2 is a schematic diagram of an assembly structure of a medical device according to an embodiment of the present invention;

[0035] Figure 3 is a schematic diagram of a longitudinal section of a medical device according to an embodiment of the present invention;

[0036] Figure 4 is a schematic diagram of an exploded structure of a medical device according to an embodiment of the present invention;

[0037] Figure 5 is a schematic diagram of a structure of a medical device placed in a human body according to an embodiment of the present invention;

[0038] Figure 6 is a schematic diagram of a clamping arm of a medical device according to an embodiment of the present invention;

[0039] Figure 7 is a schematic diagram of a rotating arm of a medical device according to an embodiment of the present invention;

[0040] Figure 8 is a schematic diagram of a clamping arm base of a medical device according to an embodiment of the present invention;

[0041] Fig. 9 is a schematic diagram of a rotating arm base of a medical device according to an embodiment of the present invention;

[0042] Fig.10 is a schematic diagram of a rod of a medical device according to an embodiment of the present invention;

[0043] Fig.11 is a schematic diagram of a dissociation device of a medical device according to an embodiment of the present invention;

[0044] Fig.12 is a schematic diagram of a longitudinal section of a structure of a medical device placed in a human body according to an embodiment of the present invention;

[0045] Fig.13 is a schematic diagram of a medical device clamping human tissue according to an embodiment of the present invention;

[0046] Figure 14-15 is a schematic diagram of the opening and closing angle adjustment of a medical device according to an embodiment of the present invention;

[0047] Fig.16 is a partially enlarged schematic diagram of a medical device in a locked state according to an embodiment of the present invention;

[0048] Fig.17 is a schematic diagram of characteristic dimensions of a locking mechanism of a medical device in the prior art;

[0049] Fig.18Schematic diagram of characteristic dimensions of a locking mechanism of a medical device according to an embodiment of the present invention. DETAILED DESCRIPTION

[0050] The following is a description of exemplary embodiments of the present invention in conjunction with the accompanying drawings, including various details of the embodiments of the present invention to facilitate understanding, which should be considered as merely exemplary. Therefore, it should be recognized by those of ordinary skill in the art that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present invention. Similarly, for clarity and conciseness, the description of well-known functions and structures is omitted in the following description.

[0051] According to one aspect of an embodiment of the present invention, a snap-fit ​​locking medical device is provided.

[0052] The clamping and locking medical device involved in the embodiment of the present invention is mainly used in implantable devices, especially in implantable devices for treating heart valve diseases. Figures 2 to 4 The illustrated embodiment describes a medical device with a snap-on lock, including a first connecting element, one end of which has a clamping portion, which is used to clamp human tissue. In practical applications, the clamping portion can be a clamping arm 101, and can be provided in pairs to facilitate the purpose of clamping human tissue. The other end of the first connecting element has a snap-on component 102 extending axially. The medical device also includes a second connecting element 103, and the side wall of the second connecting element is provided with a connecting device 104 connected to the first connecting element. Figures 2 to 4 As shown, the outer peripheral side wall of the second connecting element is provided with a groove, and the groove is used to pivotally connect one end of the connecting device 104, and the other end of the connecting device 104 is pivotally connected to the clamping part, so that the clamping part and the connecting device can rotate around their respective pivot points to adjust the opening and closing angles of the clamping part, thereby achieving the purpose of adjusting the clamping force on human tissue. Optionally, the connecting device can be a rotating arm. Furthermore, an inner hole is provided at the axis of the second connecting element. The medical device also includes a rod 105, such as Figure 3 As shown, the rod passes through the second connecting element and the clamping component in sequence and is connected to the first connecting element. In actual use, the position of the second connecting element can be fixed, and then the rod can be pulled forward and backward along the axis of the rod, thereby driving the first connecting element to move forward and backward along the axis to adjust the opening and closing angle of the clamping part. Figure 2-4 As shown, the first connecting element includes a clamping arm base 106, one end of the clamping part (which can be a clamping arm) is pivoted to the clamping arm base, and the middle part of the clamping part is pivoted to the connecting device (which can be a rotating arm). The rod is connected to the clamping arm base, so that the clamping arm base can be pushed to move forward and backward, thereby driving the clamping part to rotate to adjust the opening and closing angle of the clamping part. It can be seen that relative to Figure 1 As shown in the threaded drive mode, the present invention uses an axial pulling method to adjust the opening and closing angle of the clamping part, which can greatly improve the adjustment efficiency of the opening and closing angle, and there is no need to overcome the self-locking force of the thread. Only a small driving force is required to adjust the angle, which improves the convenience of operation. At the same time, it also avoids the problem of medical device rotation caused by the threaded rotation adjustment method, and improves the accuracy of human tissue clamping. When the rod drives the first connecting element to adjust the clamping angle, and the human tissue is clamped in place, the clamping component can be released to fix the angle of the clamping part. That is, this case no longer uses the self-locking structure of the thread to achieve the locking of the clamping angle, but uses a clamping structure. After completing the above operations, the rod can be released to complete the clamping, and the device left in the human body is only Figure 5 See Figure 17-18 as well as Figure 1 It can be seen that the device of the present invention is better than Figure 1 The portion shown as being retained in the human body significantly reduces weight and human body burden, thereby reducing postoperative risks.

[0053] Optional, such as Figure 4 As shown, the first connecting element is a clamping arm base; the clamping component is arranged near the second connecting element, see Figure 4 The sheet structure on the right side of the middle clamping arm base. The clamping arm base is provided with an inner hole, and a connecting component detachably connected to the rod is provided at a position of the inner hole near the clamping part.

[0054] Optionally, the clamping portion further comprises at least two clamping arms, such as Figure 5-6 As shown, the middle portion of the clamping arm is pivotally connected to one end of the connecting device, and one end of the clamping arm is pivotally connected to the clamping arm base. Figure 7 As shown, the connecting device can be a rotating arm.

[0055] Optionally, the detachably connected connecting component is a threaded structure. The threaded structure can facilitate the connection and disassembly of the rod, reduce the complexity of the structure, facilitate processing, and save costs.

[0056] Optional, such as Figure 4 As shown, the second connecting element is a rotating arm base, the side surface of the rotating arm base is pivotally connected to one end of the connecting device, and the other end of the connecting device is pivotally connected to the clamping portion.

[0057] Optionally, the connecting device comprises at least two rotating arms.

[0058] Optional, such as Figure 8As shown, the clamping component includes a card. In practical applications, the card can be arranged on the end surface close to the second connecting element. The inner surface of the card is a smooth surface, and the outer surface is a toothed structure. The card is arranged along the circumference of the inner hole of the first connecting element; the inner hole surface of the second connecting element is provided with a boss. Fig.16 As shown, the boss can be formed by a step-shaped structure. When the engaging member is released, the card returns to its original state so that the tooth-shaped structure engages with the boss. Fig.16 As shown, the toothed structure is engaged with the step, thereby locking the positions of the various components of the medical device, and then locking the opening and closing angles of the clamping part, and finally achieving the purpose of fixing the medical device and the human tissue together. Fig.16 As shown, the present invention adopts a newly designed snap-fit ​​structure, or a locking mechanism, which locks the instrument with tooth-like features through deformation of the card (or a locking arm), thereby reducing the axial size of the clamped instrument. Fig.17 The characteristic dimensions of the locking mechanism in the prior art are shown, which are 4.58 mm in length. Fig.18 The characteristic size of the locking mechanism in one embodiment of the present invention is shown, and its length is 3.20 mm. It can be seen that the new structure of the present invention effectively reduces the size of the locking mechanism and reduces the weight of the medical device.

[0059] Optionally, the card is at least two pieces and is made of shape memory material. In practice, the shape memory material includes but is not limited to shape memory alloy. Fig.16 Therefore, in use, as long as the shape of the card is effectively controlled, the opening and closing angle of the clamping part of the medical device can be locked only when needed. It is understandable that in addition to shape memory materials, the card can also be made of conventional elastic materials, that is, it can be pre-bent into Figure 8 In the unlocking stage of the medical device, the wall surface of the inner hole of the tubular dissociation device can be used to constrain its shape so that it can be folded in the inner hole of the dissociation device; and when the dissociation device is evacuated, it will return to the shape of Figure 8 The shape shown is used to achieve the purpose of snap-on locking.

[0060] Optional, such as Figure 3 , 4 As shown in FIG. 11 , the medical device of the present invention further comprises a dissociation device 107, which is a tubular object. Fig.11 The disengagement device is arranged between the clamping component and the second connecting element to constrain the shape of the clamping component. Figure 3As shown, when in use, the dissociation device can be sleeved on the rod and inserted into the inner hole of the second connecting element, and then the clamping component (such as the card mentioned above) is extended into the inner hole of the dissociation device and is located in the gap between the dissociation device and the rod. Optionally, the outer peripheral wall of the rod is clearance-matched with the clamping component, so as not to affect the connection, disassembly and axial movement of the rod. Since the clamping component has a tendency to move radially and restore the original deformation, in the non-locking stage of the medical device, it is necessary to use the wall surface of the inner hole of the dissociation device to constrain the above-mentioned deformation tendency. In the locking stage, the dissociation device can be evacuated, so that the clamping component restores the original deformation and engages with the step-shaped boss to lock the angle of the clamping portion.

[0061] According to a second aspect of an embodiment of the present invention, a method for using a medical device with a snap-on lock is provided, which is used to operate any one of the medical devices described in the first aspect of the present invention. In actual use, the medical device is first delivered to a target area, such as the heart, through a delivery system; after determining the target point, the rod is driven to drive the first connecting element to move axially, thereby adjusting the angle of the clamping portion to clamp the human tissue. After clamping the human tissue, the clamping portion is tightened by driving the rod to move backward. The above-mentioned surgical procedure can be repeated to obtain the desired tissue clamping effect. When the clamping portion reaches the target clamping angle, the snap-on component is released to engage the first connecting element with the second connecting element, thereby fixing the target clamping angle. Finally, the rod is released to disengage the rod from the first connecting element to complete the clamping.

[0062] According to a third aspect of an embodiment of the present invention, a method for using a medical device with a snap-on lock is provided, which is used to operate the medical device with a dissociation device described in the first aspect of the present invention. In specific use, the medical device is first delivered to the target area, such as the heart, through a conveying system; after determining the target point, the rod is driven to drive the first connecting element to move axially, thereby adjusting the angle of the clamping part to clamp the human tissue. After clamping the human tissue, the clamping part is tightened by driving the rod to move backward. The above-mentioned surgical process can be repeated to obtain the desired tissue clamping effect. When the clamping part reaches the target clamping angle, the snap-on component is released to engage the first connecting element with the second connecting element, thereby fixing the target clamping angle. Finally, the rod is released to disengage the rod from the first connecting element to complete the clamping.

[0063] Optionally, the releasing of the clamping component includes withdrawing the tubular object disposed between the clamping component and the second connecting element to release the shape constraint of the clamping component. That is, after confirming that the clamping effect is correct, the tubular disengaging device is withdrawn, and the card (or locking arm) on the clamping arm base loses the constraint of the inner wall of the disengaging device, and due to the characteristics of the shape memory material, it recovers its deformation and warps to both sides, such as Figure 8As shown, the warped tooth-like feature will be clamped on the rotating arm base, thereby restricting the axial movement of the clamping arm base, and locking the clamping part (such as the clamping arm). After completing the above operation, the rod can be rotated to disengage the clamping arm base threaded therewith, and the implantation process of the device is completed.

[0064] Optionally, the clamping component includes a card; the inner surface of the card is a smooth surface, and the outer surface is a toothed structure, and the card is arranged along the circumference of the inner hole of the first connecting element; the inner hole surface of the second connecting element is provided with a boss; optionally, the boss can be formed by a step structure. When the clamping component is released, the card returns to its original state so that the toothed structure is engaged with the boss.

[0065] Optionally, the card is at least two pieces, and is made of a shape memory material. As mentioned above, the shape memory material may be a shape memory alloy; or the card may also be made of a conventional elastic material.

[0066] The above specific implementations do not constitute a limitation on the protection scope of the present invention. It should be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions may occur depending on design requirements and other factors. Any modification, equivalent substitution and improvement made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A card-locked medical device, comprising: A first connecting element, having a clamping portion at one end and a clamping component extending in the axial direction at the other end; A second connecting element, whose side wall is provided with a connecting device connected to the first connecting element; and an inner hole is provided at its axis; A rod member, the rod member sequentially passes through the second connecting element and the clamping component to be connected with the first connecting element; Features: The rod pulls the first connecting element to move forward and backward to adjust the clamping angle. After the human tissue is clamped in place, the clamping component is released to fix the angle of the clamping part, and then the rod is released to complete the clamping. The first connecting element is a clamping arm base; the clamping component is arranged at a position close to the second connecting element; the clamping arm base is provided with an inner hole, and a connecting component detachably connected to the rod is arranged at a position close to the clamping portion of the inner hole; The second connecting element is a rotating arm base, the side surface of the rotating arm base is pivotally connected to one end of the connecting device, and the other end of the connecting device is pivotally connected to the clamping portion; The clamping component includes a card; the inner surface of the card is a smooth surface, and the outer surface is a toothed structure, and the card is arranged along the circumference of the inner hole of the first connecting element; a boss is arranged on the inner hole surface of the second connecting element; when the clamping component is released, the card returns to its original state so that the toothed structure is engaged with the boss; It also includes a disengaging device, which is a tubular object and is arranged between the clamping component and the second connecting element to constrain the shape of the clamping component.

2. The medical device according to claim 1, characterized in that: The clamping part also includes at least two clamping arms, the middle part of the clamping arm is pivotally connected to one end of the connecting device, and one end of the clamping arm is pivotally connected to the clamping arm base.

3. The medical device according to claim 1, characterized in that: The detachably connected connection part is a threaded structure.

4. The medical device according to claim 1, characterized in that: The connecting device comprises at least two swivel arms.

5. The medical device according to claim 1, characterized in that: The card consists of at least two pieces and is made of shape memory material.

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