Tissue closure clip
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- BEIJING LINGJIAN MEDICAL TECH CO LTD
- Filing Date
- 2025-11-21
- Publication Date
- 2026-06-04
Smart Images
Figure CN2025136733_04062026_PF_FP_ABST
Abstract
Description
tissue closure clip
[0001] This application claims priority to Chinese Patent Application No. 2024117088032, filed on November 26, 2024, entitled “Tissue Closure Clip”, the entire contents of which are incorporated herein by reference.
[0002] Technical Field
[0003] Embodiments of this disclosure relate to the field of interventional medical devices. More specifically, this disclosure relates to a tissue closure clip. Background Technology
[0004] Tissue closure clips play a crucial role in various surgical procedures, particularly in left atrial appendage closure. In this minimally invasive procedure, after perforation, a tissue closure clip is placed at the base of the patient's left atrial appendage using a delivery device. Then, only the delivery system is removed from the body, and the tissue closure clip closes the left atrial appendage from outside the heart, preventing blood from entering the heart, eliminating thrombus sources, and reducing the risk of stroke due to atrial fibrillation.
[0005] Traditional tissue closure clips mainly consist of a first clamping arm, a second clamping arm, and a clamping body connecting the two. The clamping body provides continuous elasticity to ensure that the first and second clamping arms can stably clamp and close the target tissue, such as the left atrial appendage. However, the size limitations of existing technology lead to some problems: when the tissue closure clip is in the closed state, the fit between the first and second clamping arms is not tight enough, causing the tissue closure clip to fail to provide balanced clamping and closure of the left atrial appendage, which may reduce the success rate of the surgery.
[0006] Furthermore, through follow-up studies of numerous surgeries, the researchers in this publication discovered that the existing tissue closure clips, when open, have a close proximal distance (1-2.5 mm) between the first and second clip arms, making them suitable only for most patients and not for a small number of patients with thicker left atrial appendages. When the thickness at the root of the left atrial appendage is relatively high (around 3 mm), the tissue closure clips may not be able to reach the ideal clamping position, making it difficult to perform balanced and complete clamping and closure of the left atrial appendage, increasing the failure rate of the surgery and the patient's suffering.
[0007] Summary of the Invention
[0008] To address one or more of the technical problems mentioned above, this disclosure provides a tissue closure clip that can be delivered to an ideal clamping position at the root of the left atrial appendage of more or even all patients, and to clamp and close the left atrial appendage evenly and completely, thereby improving the success rate of the procedure and reducing patient suffering.
[0009] This disclosure provides a tissue closure clip, comprising: a clip body including a first pressure arm and a second pressure arm extending longitudinally and spaced laterally, and a bent arm connecting the proximal ends of the first pressure arm and the second pressure arm; and a first clamping arm and a second clamping arm, both extending longitudinally between the first pressure arm and the second pressure arm and contacting each other, wherein the first clamping arm includes a first connecting portion disposed between its proximal and distal ends for connecting the distal end of the first pressure arm, and the second clamping arm includes a second connecting portion disposed between its proximal and distal ends for connecting the distal end of the second pressure arm; wherein the tissue closure clip is configured to satisfy the following requirements: L=L', L1=L1', L2=L2', L3=L3', L4=L4', L4< L2; L = 35~50mm, L1 / L = 0.58~0.84, L3 / L2 = 1.8~2.9; where L is the longitudinal dimension of the first clamping arm; L' is the longitudinal dimension of the second clamping arm; L1 is the longitudinal distance from the proximal start of the first clamping arm to the proximal start of the first connecting part; L1' is the longitudinal distance from the proximal start of the second clamping arm to the proximal start of the second connecting part; L2 is the transverse dimension of the proximal end of the first clamping arm; L2' is the transverse dimension of the proximal end of the second clamping arm; L3 is the transverse dimension of the first clamping arm at the proximal start of the first connecting part; L3' is the transverse dimension of the second clamping arm at the proximal start of the second connecting part; L4 is the transverse dimension of the first pressure arm; L4' is the transverse dimension of the second pressure arm.
[0010] The tissue closure clip disclosed herein has been carefully optimized in terms of dimensions, enabling the first and second clamping arms to fit tightly together in the closed state, ensuring balanced clamping of the left atrial appendage when in the holding state. More importantly, when the tissue closure clip is in the open state, the proximal distance between the first and second clamping arms exceeds 4 mm, and the distal distance exceeds 12 mm, ensuring that the first and second clamping arms can form a stable figure-eight shape. Considering that the thickness of the left atrial appendage root in most patients is within the range of 1-3 mm, and in very few patients it will not exceed 4 mm, the first and second clamping arms of the aforementioned tissue closure clip can be more accurately and conveniently inserted into both sides of the left atrial appendage and reach the ideal clamping position, providing balanced and complete clamping and closure of the left atrial appendage. In other words, the tissue closure clip disclosed herein will not have the problem of being unable to reach the ideal clamping position in a few patients due to the excessively close distance between the proximal ends of the first and second clamping arms, as is the case with existing tissue closure clips. This ensures that it can be delivered to the ideal clamping position at the root of the left atrial appendage in more, or even all, patients, and achieve balanced and complete clamping and closure of the left atrial appendage, thereby significantly improving the success rate of the operation and reducing patient suffering. Attached Figure Description
[0011] The above and other objects, features, and advantages of exemplary embodiments of the present disclosure will become readily apparent upon reading the following detailed description with reference to the accompanying drawings. In the drawings, several embodiments of the present disclosure are illustrated by way of example and not limitation, and like or corresponding reference numerals denote like or corresponding parts, wherein:
[0012] Figure 1 shows a perspective view of the tissue closure clamp in the closed state according to an embodiment of the present disclosure;
[0013] Figure 2 shows a plan view of the tissue closure clamp in the closed state according to an embodiment of the present disclosure;
[0014] Figure 3 shows a plan view of the tissue closure clamp in the open state according to an embodiment of the present disclosure. Detailed Implementation
[0015] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this disclosure. All other embodiments obtained by those skilled in the art based on the embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.
[0016] To elaborate on the tissue closure clip 100 mentioned in the embodiments of this disclosure, several key terms are clearly defined: distal end refers to the end of the object being described (such as the tissue closure clip or its components) that is furthest from the operator during the procedure; proximal end refers to the end of the object being described that is closest to the operator during the procedure; proximal start point refers to the point or surface of the object being described that is closest to its proximal end and furthest from its distal end, marking the starting position of the object being described; distal end point is the point or surface of the object being described that is closest to its distal end and furthest from its proximal end, representing the ending position of the object being described.
[0017] To address the challenges in the prior art and achieve the disclosed objectives, this disclosure provides a tissue closure clip 100. This tissue closure clip 100 is generally made of titanium alloy (such as TC4 or TC20), stainless steel, or nickel-titanium alloy (such as TiNi-1, TiNi-2, or TiNi-3) and is a one-piece molded structure. The one-piece molded tissue closure clip 100 made of titanium alloy, stainless steel, or nickel-titanium alloy exhibits significant advantages in terms of elastic recovery, biocompatibility, and imaging observation, facilitating safer and more efficient surgical procedures.
[0018] Figures 1 and 2 both illustrate a tissue closure clip 100 according to an embodiment of the present disclosure. As shown in Figures 1 and 2, the tissue closure clip 100 includes a clip body 1. The clip body 1 includes a first pressure arm 11 and a second pressure arm 12 extending longitudinally and spaced laterally, and a bent arm 13 connecting the proximal end of the first pressure arm 11 and the proximal end of the second pressure arm 12. As a preferred example, the clip body 1 may be a generally U-shaped structure that is simple in structure, easy to manufacture, and low in cost.
[0019] The tissue closure clip 100 also includes a first clamping arm 2 and a second clamping arm 3. The first clamping arm 2 extends longitudinally and is disposed between the first pressure arm 11 and the second pressure arm 12, and includes a first connecting portion 21 (shown as a dotted line in Figure 1) between its proximal and distal ends, so that the first clamping arm 2 is connected to the distal end of the first pressure arm 11 via the first connecting portion 21. The second clamping arm 3 extends longitudinally and is disposed between the first pressure arm 11 and the second pressure arm 12, and includes a second connecting portion 31 (shown as a dotted line in Figure 1) between its proximal and distal ends, so that the second clamping arm 3 is connected to the distal end of the second pressure arm 12 via the second connecting portion 31.
[0020] The tissue closure clip 100 includes a closed state, an open state, and a clamping state. In the closed state, the clip body 1 is in its original state, and the first clamping arm 2 and the second clamping arm 3 are tightly fitted under the constraint of the clip body 1, meaning there is generally no visible gap between them. In the open state, the first clamping arm 2 and the second clamping arm 3 of the clip body 1 separate from each other and open to the desired extent, that is, the proximal distance L8 between the first clamping arm 2 and the second clamping arm 3 reaches a first set value (e.g., 4.1 mm), and the distal distance L9 between them reaches a second set value (e.g., 12.1 mm), ensuring that the first clamping arm 2 and the second clamping arm 3 form a stable figure-eight shape, see Figure 3. In the clamping state, the first clamping arm 2 and the second clamping arm 3 of the clip body 1 clamp and close the target tissues such as the left atrial appendage under the elastic force of the clip body 1.
[0021] In use, the tissue closure clip 100 needs to be fixed to the delivery device by means of binding or clamping. The operator can use the delivery device (such as the closure clip delivery system described in Chinese Patent Application Publication CN111248969A) to insert the tissue closure clip 100 from the patient's puncture site into the left atrial appendage of the heart. Before reaching the left atrial appendage, the delivery device changes the tissue closure clip 100 from a closed state to an open state, so that the first clamping arm 2 and the second clamping arm 3, which are separated by the delivery device, can be smoothly positioned on both sides of the root of the left atrial appendage. Then, the operator can manipulate the delivery device to change the tissue closure clip 100 from an open state to a clamping state and use its first clamping arm 2 and the second clamping arm 3 to clamp and close the left atrial appendage. Finally, the operator can manipulate the delivery device to release the traction and connection of the tissue closure clip 100, withdraw the delivery device from the patient's body, and suture the puncture site to complete the surgery.
[0022] In this embodiment, the contour edges of the first pressure arm 11, the second pressure arm 12, the curved arm 13, the first clamping arm 2, and the second clamping arm 3 are all provided with rounded chamfers. The rounded chamfer design makes the outer surface of the tissue closure clip 100 more rounded and smooth, reducing the risk of tissue scratching when the tissue closure clip 100 enters the patient's body.
[0023] Next, in order to optimize the size of the tissue closure clip 100 and improve its applicability, the following experiment was conducted.
[0024] Experimental objective:
[0025] The purpose of this experiment is to investigate the influence of dimensional parameters on the performance of the tissue closure clip 100.
[0026] Experimental materials:
[0027] computer;
[0028] The tissue closure clip 100, made of titanium alloy of grade TC4 as described above, simultaneously satisfies the following conditions: L=L', L1=L1', L2=L2', L3=L3', L4=L4', as shown in Figure 2.
[0029] The above-described closed clamp 100 is made of a nickel-titanium alloy of grade TiNi-3 and simultaneously satisfies the following conditions: L=L', L1=L1', L2=L2', L3=L3', L4=L4', as shown in Figure 2.
[0030] Experimental methods:
[0031] Various experimental conditions were created by adjusting the materials, L, L1 / L, L2-L4, and L3 / L2 values or their relationships. The proximal distance L8 between the first clamping arm 2 and the second clamping arm 3 was measured and recorded under each condition when the tissue closure clamp 100 was in the open state; the distal distance L9 between the first clamping arm 2 and the second clamping arm 3 was measured when the tissue closure clamp 100 was in the open state; and key parameters such as whether a gap was generated at the contact position of the first clamping arm 2 and the second clamping arm 3 after the shaped tissue closure clamp 100 obtained a stable closing force exceeding 3.5N were also measured. Based on whether the proximal distance L8 was greater than 4mm, the distal distance L9 was greater than 12mm, and whether there were any gaps, the experimental results under each condition were judged to have reached the "ideal" state, as shown in Tables 1 and 2. The stable closing force refers to the pressure between the first clamping arm 2 and the second clamping arm 3 of the shaped tissue closure clamp 100 when it was in the closed state.
[0032] Table 1: Performance of Tissue Closure Clip 100 in Different Sizes
[0033] Serial Number Material LL1 / LL2-L4L3 / L2L8L9 Yes / No 1 TC450mm 0.5 > 0.2 1.1mm 2.3mm No No 2 TC450mm 0.58 > 0.25mm 16.7mm No Yes 3 TC450mm 0.6 > 0.25 16.5mm No Yes 4 TC450mm 0.8 > 0.24 4.5mm 18mm No Yes 5 TC450mm 0.84 > 0.24 4.1mm 18.2mm No Yes 6 TC450mm 0.88 > 0.23 3.9mm 17.9mm No No 7 TC450mm 0.58 < 0.2 / / Yes / No 8 TC450mm 0.58 > 0.25mm 16.7mm No Yes 9 TC450mm 0.58 >01 / / Yes / No 10TC450mm0.58 >01.3 / / Yes / No 11TC450mm0.58 >01.86.8mm14mm No Yes 12TC450mm0.58 >02.94.3mm17.9mm No Yes 13TC450mm0.84 >02.94.4mm14mm No Yes 14TC450mm0.84 >01.45 / / Yes / No 15TC450mm0.84 >01.6 / / Yes / No 16TC450mm0.84 >01.85.1mm21mm No Yes 17TC450mm0.68 >01.85.96mm19.4mm No Yes 18TC450mm0.68 >02.95.73m m19.8mm None Yes 19TC450mm 0.72 > 0 1.8 5.8mm 19.1mm None Yes 20TC450mm 0.72 > 0 2.9 5.3mm 17.3mm None Yes 21TC450mm 0.75 > 0 1.8 5.49mm 19.7mm None Yes 22TC450mm 0.75 > 0 2.9 4.77mm 18.1mm None Yes 23TC450mm 0.75 > 0 1.45 / / Yes No 24TC450mm 0.75 > 0 1.65 / / Yes No 25TC440mm 0.58 > 0 1.8 6.5mm 14.8mm None Yes 26TC440mm 0.58 > 0 2.9 6.37mm 13.4mm None Yes 27T C440mm 0.84 > 01.85.2mm 14.4mm None Yes 28TC440mm 0.84 > 02.94.9mm 14.8mm None Yes 29TC435mm 0.58 > 01.85.8mm 13.2mm None Yes 30TC435mm 0.58 > 02.95.6mm 13.5mm None Yes 31TC435mm 0.84 > 01.85.4mm 15.6mm None Yes 32TC435mm 0.84 > 02.95.1mm 14.6mm None Yes 33TiNi-350mm 0.58 > 01.85.94mm 19.9mm None Yes 34TiNi-350mm 0.58 > 02.94.12mm 20.3mm is not available for 35TiNi-350mm 0.84 > 0 1.8 4.07mm 15.6mm is not available for 36TiNi-350mm 0.84 > 0 2.9 4.7mm 14.5mm is not available for 37TiNi-335mm 0.58 > 0 1.8 5.4mm 15.4mm is not available for 38TiNi-335mm 0.58 > 0 2.9 4.3mm 15.8mm is not available for 39TiNi-335mm 0.84 > 0 1.8 4.7mm 17.2mm is not available for 40TiNi-335mm 0.84 > 0 2.95mm 17.2mm is not available for 40TiNi-335mm 0.84 > 0 2.95mm 17.2mm is not available for 40TiNi-335mm 0.84 > 0 2.95mm 17.2mm is not available for 40TiNi-335mm
[0034] Experimental Analysis:
[0035] When the tissue closure clip 100 is made of titanium alloy of grade TC4 and L=50mm, the reasonable range of L1 / L is 0.58~0.84, see Table 1, serial numbers 1~6;
[0036] When the tissue closure clip 100 is made of titanium alloy of grade TC4, and L=35~50mm, L1 / L=0.58-0.84, the reasonable range of L3 / L2 is 1.8~2.9, see Table 1, serial numbers 8~32;
[0037] When the tissue closure clamp 100 is made of nickel-titanium alloy of grade TiNi-3, and L=35~50mm, L1 / L=0.58-0.84, the reasonable range of L3 / L2 is 1.8~2.9, see Table 1, serial numbers 33~40;
[0038] Based on the theory that the thicker the material, the greater the stiffness, and combined with the experimental results of numbers 7-8, it is known that under all conditions, L4 < L2. Otherwise, the shaped tissue closure clip 100 is prone to gaps at the contact position of the first clip arm 2 and the second clip arm 3, which causes the tissue closure clip 100 to fail to perform balanced and complete clamping and closure of the left atrial appendage.
[0039] Experimental conclusion:
[0040] The tissue closure clip 100 should be configured to at least meet the following requirements:
[0041] L=L', L1=L1', L2=L2', L3=L3', L4=L4', L4<L2;
[0042] L=35~50mm, L1 / L=0.58~0.84, L3 / L2=1.8~2.9;
[0043] In the formula, L is the longitudinal dimension of the first clamping arm 2; L' is the longitudinal dimension of the second clamping arm 3; L1 is the longitudinal distance from the proximal starting point of the first clamping arm 2 to the proximal starting point 21a of the first connecting part 21; L1' is the longitudinal distance from the proximal starting point of the second clamping arm 3 to the proximal starting point 31a of the second connecting part 31; L2 is the transverse dimension of the proximal end of the first clamping arm 2; L2' is the transverse dimension of the proximal end of the second clamping arm 3; L3 is the transverse dimension of the first clamping arm 2 at the proximal starting point 21a of the first connecting part 21; L3' is the transverse dimension of the second clamping arm 3 at the proximal starting point 31a of the second connecting part 31; L4 is the transverse dimension of the first pressure arm 11; L4' is the transverse dimension of the second pressure arm 12.
[0044] Based on the experimental results and the above requirements, the tissue closure clip 100 disclosed herein has been carefully optimized in terms of dimensions. This allows the tissue closure clip 100 to ensure that the first clamping arm 2 and the second clamping arm 3 fit tightly together when in the closed state, and to ensure that the left atrial appendage is held evenly by the first clamping arm 2 and the second clamping arm 3 when in the clamping state. More importantly, when the tissue closure clip 100 is in the open state, the proximal distance L8 between the first clamping arm 2 and the second clamping arm 3 exceeds 4 mm, and the distal distance L9 between the two exceeds 12 mm, ensuring that the first clamping arm 2 and the second clamping arm 3 form a stable figure-eight shape (see Figure 3). Considering that the thickness of the left atrial appendage root in most patients is within the range of 1-3 mm, and in very few patients it will not exceed 4 mm, the first clamping arm 2 and the second clamping arm 3 of the aforementioned tissue closure clip 100 can be more accurately inserted into both sides of the left atrial appendage and reach the ideal clamping position, and to hold and close the left atrial appendage evenly and completely. In other words, the tissue closure clip 100 disclosed herein does not suffer from the problem of the first and second clip arms being too close together, which prevents it from being delivered to the ideal clamping position in a few patients. This ensures that it can be delivered to the ideal clamping position at the root of the left atrial appendage in more, or even all, patients, and performs balanced and complete clamping and closure of the left atrial appendage. This can significantly improve the success rate of the operation and reduce the patient's pain.
[0045] As a preferred example, the tissue closure clip 100 is configured to meet the following requirements: L1 / L = 0.68~0.75, L3 / L2 = 2.2~2.7.
[0046] Table 2: Performance of Tissue Closure Clip 100 at Some Preferred Sizes
[0047] Serial Number | Material | LL1 / LL2-L4 | L3 / L2 | L8 | L9 | Stable Closing Force | 1 | TC450mm | 0.68 | >0.226mm | 17.7mm | 4.55N | 2 | TC450mm | 0.68 | >0.276mm | 17.5mm | 4.5N | 3 | TC450mm | 0.75 | >0.25 | 1mm | 21mm | 4.89N | 4 | TC450mm | 0.75 | >0.275mm | 20. 6mm5.17N5TC435mm0.68>02.26.4mm15.6mm4.6N6TC435mm0.68>02.75.6mm17.7mm4.9N 7TC435mm0.75>02.25.9mm16.8mm4.9N8TC435mm0.75>02.76.2mm16mm4.77N9TiNi-350 mm0.68>02.25.58mm19.38mm4.86N10TiNi-350mm0.68>02.75.35mm20.41mm4.49N11Ti Ni-350mm0.75>02.25.5mm19.8mm4.8N12TiNi-350mm0.75>02.75.58mm18.75mm4.8N13 TiNi-335mm0.68>02.25.8mm16mm5.12N14TiNi-335mm0.68>02.75.2mm16.4mm4.61N15 TiNi-335mm0.75>02.25.1mm15.8mm4.54N16TiNi-335mm0.75>02.75.7mm16.4mm4.66N
[0048] According to the data in Table 2, when the ratio of L1 to L is between 0.68 and 0.75, and the ratio of L3 to L2 is between 2.2 and 2.7, the tissue closure clip 100 can exhibit a more closely expected opening amplitude and shape in the open state, and can also provide a stable closing force of 4.49~5.17N.
[0049] To further verify the effectiveness of the Tissue Closure Clip 100 when it achieves a stable closure force of 4.49–5.17 N, an animal experiment was conducted. Dogs were used as experimental animals. Seven samples meeting the criteria for items 4 and 10 in Table 2 were sequentially implanted into the left atrial appendage of seven dogs via surgical thoracotomy, and used to close the corresponding canine left atrial appendage. The experiment included multiple study points at 7, 60, 90, and 180 days for anatomical observation. One dog was dissected at 7 days, two at 60 days, three at 90 days, and one at 180 days. The closed portion of the left atrial appendage was collected for histopathological analysis. During the study, all clinical indicators and tests in the animals were normal, including blood parameters, serum atrial natriuretic peptide (ANP) levels, and histopathological analysis, to evaluate the feasibility, safety, and effectiveness of the Tissue Closure Clip 100 in canine left atrial appendage closure. The experimental results showed that the tissue closure clip 100 could completely close the left atrial appendage. As the closure time increased, the left atrial appendage gradually atrophied and completely atrophied after 60 days. No obvious morphology was observed in other tissues except for the closed area of the left atrial appendage.
[0050] In this embodiment, as shown in FIG1, when the tissue closure clip 100 is in the closed state, the distance between the distal outer surface of the first pressure arm 11 and the distal outer surface of the second pressure arm 12 is greater than the distance between the distal outer surface of the first clamping arm 2 and the distal outer surface of the second clamping arm 3. This ensures that the lateral dimension of the tissue closure clip 100 at the distal end is smaller, thereby facilitating the smooth insertion of the tissue closure clip 100 into the patient's body and the location of the left atrial appendage.
[0051] In this embodiment, as shown in Figures 1 and 2, the distal outer surface of the first pressure arm 11 and the distal outer surface of the second pressure arm 12 can both be selected as streamlined surfaces or zigzag surfaces. As a preferred example, the distal outer surface of the first pressure arm 11 is constructed as a first streamlined surface, and the lateral distance from the first streamlined surface to the first clamping arm 2 gradually decreases longitudinally along the direction closer to the distal end of the first clamping arm 2; the distal outer surface of the second pressure arm 12 is constructed as a second streamlined surface, and the lateral distance from the second streamlined surface to the second clamping arm 3 gradually decreases longitudinally along the direction closer to the distal end of the second clamping arm 3. The first streamlined surface and the second streamlined surface can improve the smoothness and safety of the tissue closure clip 100 when it is inserted into the patient's body and the left atrial appendage.
[0052] As an example, the tissue closure clip 100 is constructed to also satisfy the following requirements: L6 = L6', L2 ≤ L6 ≤ L3. Where L6 is the lateral dimension of the distal end of the first clip arm 2, and L6' is the lateral dimension of the distal end of the second clip arm 3. Studies have found that the lateral dimensions of the distal ends of the first clip arm 2 and the second clip arm 3 should not be too large or too small. If they are too large, it increases the resistance when the tissue closure clip 100 enters; if they are too small, it easily induces plastic deformation, thus affecting the balance of clamping. However, when L2 ≤ L6 ≤ L3, the lateral dimensions of the distal ends of the first clip arm 2 and the second clip arm 3 reach an ideal balance point, reducing the resistance during entry while ensuring the stability and balance of clamping, thereby improving the safety and efficiency of the surgical procedure.
[0053] As an example, the tissue closure clip 100 is constructed to also satisfy the following requirements: L7 = L7', L7 / L = 0.05~0.15. Wherein, L7 is the longitudinal dimension from the distal end 21b of the first connecting portion 21 to the distal end of the first clamping arm 2, and L7' is the longitudinal dimension from the distal end 31b of the second connecting portion 31 to the distal end of the second clamping arm 3. In this way, not only can the structural symmetry of the tissue closure clip 100 be further improved, but the extension range of the first streamlined surface and the second streamlined surface can also be indirectly limited, ensuring that the tissue closure clip 100 can be inserted into the patient's body more smoothly and reliably, thereby effectively improving the success and safety of the surgery.
[0054] In this embodiment, the tissue closure clip 100 may further include a first loading structure 4 disposed on the first clamping arm 2 and a second loading structure 5 disposed on the second clamping arm 3, as shown in Figures 1 and 3. The first loading structure 4 and the second loading structure 5 are used to connect the tissue closure clip 100 to the delivery device, so that the delivery device can drive the tissue closure clip 100 to switch between a closed state and an open state. The first loading structure 4 and the second loading structure 5 ensure that the tissue closure clip 100 can be accurately mounted on the delivery device, and ensure that the opening amplitude and shape are closer to the ideal, avoiding the problems of excessive or insufficient opening amplitude or undesirable opening shape that may occur in the prior art, thereby improving the efficiency and safety of the surgical operation.
[0055] The aforementioned loading structure is generally determined according to the corresponding connection structure used in the conveying device, and can typically be selected as a through hole, groove, or protrusion. As an example, the first loading structure 4 includes a first through hole penetrating both sides of the first clamping arm 2, and the second loading structure 5 includes a second through hole penetrating both sides of the second clamping arm 3. The first and second through holes allow wires or straps to pass through and, through binding, precisely and securely mount the tissue closure clip 100 onto the conveying device. As another example, the first loading structure 4 includes multiple first slots respectively provided on both sides of the first clamping arm 2, i.e., each side of the first clamping arm 2 has at least one first slot; the second loading structure 5 includes multiple second slots respectively provided on both sides of the second clamping arm 3, i.e., each side of the second clamping arm 3 has at least one second slot. In this case, if the conveying device is provided with multiple first protrusions that mate with each of the first slots, and second protrusions that mate with each of the second slots, then the interlocking slots and protrusions can precisely and securely mount the tissue closure clip 100 onto the conveying device. As another example, the first loading structure 4 includes a plurality of first latching protrusions respectively disposed on both sides of the first clamping arm 2, that is, each side of the first clamping arm 2 has at least one first latching protrusion; the second loading structure 5 includes a plurality of second latching protrusions respectively disposed on both sides of the second clamping arm 3, each side of the second clamping arm 3 has at least one second latching protrusion. In this case, if the conveying device is provided with a plurality of first grooves that mate with each of the first latching protrusions and a plurality of second grooves that mate with each of the second latching protrusions, then the interlocking latching protrusions and grooves can accurately and safely mount the tissue closure clamp 100 onto the conveying device.
[0056] Preferably, the tissue closure clip 100 can also be configured to satisfy the following requirements: L5 = L5', L5 / L1 = 0.33~0.57. Wherein, L5 is the longitudinal distance from the center of the first loading structure 4 to the proximal start of the first clamping arm 2, and L5' is the longitudinal distance from the second loading structure 5 to the proximal start of the second clamping arm 3. The equal design of L5 and L5' can further improve the structural symmetry and stability of the tissue closure clip 100 during opening and closing. Studies have shown that the specific values of L5 and L5' not only affect the energy consumption required by the delivery device when opening the tissue closure clamp 100, but also affect the degree and shape of the tissue closure clamp 100 in the open state. Therefore, through a large number of experiments, it has been verified that when L5=L5' and L5 / L1=0.33~0.57, the delivery device can complete the transition of the tissue closure clamp 100 from closed to open with minimal energy consumption, and ensure that the degree and shape of the tissue closure clamp 100 in the open state are closer to the expectation. That is, the proximal distance L8 between the first clamp arm 2 and the second clamp arm 3 reaches the first set value (e.g., 4.1 mm), and the distal distance L9 between the two reaches the second set value (e.g., 12.1 mm), ensuring that the first clamp arm 2 and the second clamp arm 3 form a stable figure-eight shape, as shown in Figure 3.
[0057] In summary, the tissue closure clip 100 of this embodiment can be delivered to the ideal clamping position at the root of the left atrial appendage of more or even all patients, and perform balanced and complete clamping and closure of the left atrial appendage, thereby improving the success rate of the operation and reducing the patient's pain.
[0058] In the foregoing description of this disclosure, unless otherwise expressly specified and limited, the terms "fixed," "installed," "connected," or "linked" should be interpreted broadly. For example, the term "linked" can refer to a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; or it can refer to the internal communication of two components or the interaction between two components. Therefore, unless otherwise expressly limited by this disclosure, those skilled in the art can understand the specific meaning of the above terms in this disclosure according to the specific circumstances.
[0059] Based on the above description of this disclosure, those skilled in the art will also understand that terms used, such as "longitudinal" and "lateral," which indicate orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings of this disclosure. They are used only for the purpose of facilitating the explanation of the scheme of this disclosure and simplifying the description, and do not imply that the device or element involved must have the specific orientation, or be constructed and operated in a specific orientation. Therefore, the above-mentioned orientation or positional relationship terms should not be understood or interpreted as a limitation on the scheme of this disclosure.
[0060] Furthermore, the terms "first" or "second," etc., used in this disclosure to refer to numbers or ordinal numbers are for descriptive purposes only and should not be construed as indicating relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this disclosure, "a plurality of" means at least two, such as two, three, or more, unless otherwise explicitly specified.
[0061] While numerous embodiments of this disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Many modifications, alterations, and alternatives will occur to those skilled in the art without departing from the spirit and intent of this disclosure. It should be understood that various alternatives to the embodiments of this disclosure described herein may be employed in the practice of this disclosure. The appended claims are intended to define the scope of this disclosure and therefore cover equivalents or alternatives within the scope of those claims.
Claims
1. A tissue closure clip, characterized in that, include: The clamp includes a first pressure arm and a second pressure arm that extend longitudinally and are spaced laterally apart, and a bent arm that connects the proximal ends of the first pressure arm and the second pressure arm. as well as A first clamping arm and a second clamping arm are both longitudinally disposed between the first pressure arm and the second pressure arm and in contact with each other. The first clamping arm includes a first connecting portion disposed between its proximal end and its distal end for connecting the distal end of the first pressure arm. The second clamping arm includes a second connecting portion disposed between its proximal end and its distal end for connecting the distal end of the second pressure arm. The tissue closure clip is configured to meet the following requirements: L=L', L1=L1', L2=L2', L3=L3', L4=L4', L4<L2; L=35~50mm, L1 / L=0.58~0.84, L3 / L2=1.8~2.9; In the formula, L is the longitudinal dimension of the first clamping arm; L' is the longitudinal dimension of the second clamping arm; L1 is the longitudinal distance from the proximal start of the first clamping arm to the proximal start of the first connecting part; L1' is the longitudinal distance from the proximal start of the second clamping arm to the proximal start of the second connecting part; L2 is the lateral dimension of the proximal end of the first clamping arm; L2' is the lateral dimension of the proximal end of the second clamping arm; L3 is the lateral dimension of the first clamping arm at the proximal start of the first connecting part; L3' is the lateral dimension of the second clamping arm at the proximal start of the second connecting part; L4 is the lateral dimension of the first pressure arm; L4' is the lateral dimension of the second pressure arm.
2. The tissue closure clip according to claim 1, characterized in that, The tissue closure clip is configured to meet the following requirements: L1 / L=0.68~0.75, L3 / L2=2.2~2.
7.
3. The tissue closure clip according to claim 1, characterized in that, The tissue closure clip is made of titanium alloy, stainless steel or nickel-titanium alloy and is a one-piece molded structure.
4. The tissue closure clip according to claim 1, characterized in that, It also includes a first loading structure disposed on the first clamping arm and a second loading structure disposed on the second clamping arm, wherein the first loading structure and the second loading structure are used to connect the tissue closure clamp to the delivery device so that the delivery device can change the tissue closure clamp from a closed state to an open state.
5. The tissue closure clip according to claim 4, characterized in that: The first loading structure includes a first through hole penetrating both sides of the first clamping arm, or a plurality of first slots respectively disposed on both sides of the first clamping arm, or a plurality of first protrusions respectively disposed on both sides of the first clamping arm; The second loading structure includes a second through hole extending through both sides of the second clamping arm, or a plurality of second slots respectively disposed on both sides of the second clamping arm, or a plurality of second protrusions respectively disposed on both sides of the second clamping arm.
6. The tissue closure clip according to claim 4, characterized in that, The tissue closure clip is configured to also satisfy the following requirements: L5=L5', L5 / L1=0.33~0.57; where L5 is the longitudinal distance from the center of the first loading structure to the proximal start of the first clamping arm, and L5' is the longitudinal distance from the second loading structure to the proximal start of the second clamping arm.
7. The tissue closure clip according to claim 1, characterized in that, When the tissue closure clamp is in the closed state, the distance between the distal outer surface of the first pressure arm and the distal outer surface of the second pressure arm is greater than the distance between the distal outer surface of the first clamp arm and the distal outer surface of the second clamp arm.
8. The tissue closure clip according to claim 7, characterized in that, The distal outer surface of the first pressure arm is configured as a first streamlined surface, and the lateral distance from the first streamlined surface to the first clamping arm gradually decreases in the longitudinal direction along the direction closer to the distal end of the first clamping arm. The distal outer surface of the second pressure arm is configured as a second streamlined surface, and the lateral distance from the second streamlined surface to the second clamping arm gradually decreases in the longitudinal direction along the direction closer to the distal end of the second clamping arm.
9. The tissue closure clip according to claim 7, characterized in that, The tissue closure clip is configured to also satisfy the following requirements: L6 = L6', L2 < L6 ≤ L3; where L6 is the lateral dimension of the distal end of the first clip arm, and L6' is the lateral dimension of the distal end of the second clip arm.
10. The tissue closure clip according to claim 7, characterized in that, The tissue closure clip is configured to also satisfy the following requirements: L7=L7', L7 / L=0.05~0.15; where L7 is the longitudinal dimension from the distal end of the first connecting part to the distal end of the first clamping arm, and L7' is the longitudinal dimension from the distal end of the second connecting part to the distal end of the second clamping arm.