A split anastomotic clip

Abstract

The present invention relates to a split anastomotic clip, which comprises a hollow clip applicator cap body and a base for fixing the front end of an endoscope at the lower end, wherein the clip applicator cap body and the base are connected by a snap-fit ​​connection or a threaded connection. The split anastomotic clip replaces the clip applicator cap body and the fixed end base with a spiral or snap-fit ​​connection instead of a glue connection. When the anastomotic clip needs to be used for a second time during clinical surgery, there is no need to reinstall the entire set of products, nor is there a need to install a metal anastomotic clip separately.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a split anastomotic clip. Background Art

[0002] Sometimes in clinical surgery, there is a need to use an anastomotic clip for a second time. In the prior art, for this situation, either the entire set of products needs to be reinstalled, or a metal anastomotic clip needs to be installed separately.

[0003] Reinstalling the entire set of products will delay the operation and result in missing the best time for hemostasis or closure; installing a metal anastomosis clip alone may pose the risk of incomplete installation or injury to the surgeon, and transferring the installation steps originally performed by factory professionals to the clinical operating room requires more educational costs.

[0004] In clinical surgery, there are sometimes situations where endoscopic anastomotic clips need to be reused. In the prior art, this usually means that the entire set of products needs to be reinstalled, or the metal endoscopic anastomotic clip needs to be installed separately. Reinstalling the entire set of products is not only time-consuming, but may also miss the best time for hemostasis or closure; while installing the metal endoscopic anastomotic clip separately may result in incomplete installation or the risk of harming the operator. In addition, transferring the installation steps originally performed by factory professionals to the clinical operating room will also increase education costs. Summary of the invention

[0005] The present invention aims to provide a split anastomotic clip, and the technical problems to be solved include at least how to simplify the operation, reduce the risk of operational errors, and lower the material cost when the anastomotic clip needs to be used a second time in clinical practice.

[0006] In order to achieve the above-mentioned purpose, the present invention provides a split anastomosis clip, including a hollow clip cap body and a release line, and a base whose lower end is fixed to the front end of an endoscope, the clip cap body and the base are connected by a snap-on connection or a threaded connection to ensure stability and reliability; an elastic clip is sleeved on the outer peripheral wall of the clip cap body, and the release line is connected to the elastic clip; the release line is used to switch the elastic clip between a working state and an original state, when the elastic clip is in the working state, the elastic clip opens and sleeves on the outer peripheral wall of the clip cap body; when the elastic clip is in the original state, the elastic clip is detached from the clip cap body, so that the elastic clip is released and closed, thereby clamping the diseased tissue.

[0007] Preferably, the clip applier cap body has an O-shaped front port.

[0008] Preferably, the clip applier cap body has a U-shaped front port.

[0009] Preferably, for a clip applier cap body having an O-shaped front port, the limiting notch is arranged at the top of the O-shaped front port.

[0010] Preferably, for the clip cap body with a U-shaped front port, the U-shaped front port includes two oppositely disposed protrusions and two recessed portions sandwiched between the protrusions, and the limiting notch is disposed at the top of one of the protrusions.

[0011] Preferably, the elastic clip is made of memory metal.

[0012] Preferably, the first end of the release line passes upward from the bottom of the clamp cap body into the interior of the clamp cap body, and passes out from the top of the clamp cap body, and passes through the limiting notch and the through hole on the side wall of the elastic clip in sequence. After passing through the through hole, the first end of the release line is tied on the outside of the elastic clip to form a knot with the same thickness as the elastic clip.

[0013] Preferably, a portion of the release line located between the limiting notch and the through hole is clamped by the elastic clip between the outer peripheral wall of the clip cap body and the inner side wall of the elastic clip.

[0014] Preferably, the second end of the release line passes through the interior of the base from the top of the base and out from the bottom of the base, enters the front end of the endoscope and passes out from the side wall of the guide tube of the endoscope. By pulling the second end of the release line, the first end of the release line is displaced, thereby applying sufficient force to the elastic clip to disengage the elastic clip from the clip cap body, thereby releasing the elastic clip, switching the elastic clip from the working state to the original state, and the elastic clip is released and closed to clamp the diseased tissue.

[0015] When the material of the release line is polyamide, the diameter D of the release line is constrained by the first matching equation, which is:

[0016]

[0017] Wherein, D represents the diameter of the release line, in millimeters; σ represents the initial volume number of the martensitic phase transformation of the elastic clip, E represents the elastic modulus of the elastic clip; and h represents the thermal conductivity coefficient of the elastic clip, in W / (m·K).

[0018] When the material of the release line is polyester, the diameter D of the release line is constrained by the second matching equation, which is:

[0019]

[0020] When the material of the release line is polypropylene, the diameter D of the release line is constrained by the third matching equation, which is:

[0021]

[0022] Preferably, when the diameter D of the release line calculated by using the first matching equation, the second matching equation and the third matching equation is greater than or equal to 0.3 mm, the value of the diameter D is 0.3 mm; when the diameter D of the release line calculated by using the first matching equation, the second matching equation and the third matching equation is less than or equal to 0.15 mm, the value of the diameter D is 0.15 mm.

[0023] Beneficial Effects

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] The split anastomotic clip of the present invention replaces the connection between the clip applicator cap body and the fixed end base with a spiral or snap-on connection instead of a glue connection. When the anastomotic clip needs to be used again during clinical surgery, there is no need to reinstall the entire set of products or install a metal anastomotic clip separately.

[0026] Reinstalling the entire set of products will delay the operation and miss the best time for hemostasis or closure; installing the metal anastomotic clip alone may result in incomplete installation or injury to the operator, and transferring the original factory professional installation steps to the clinical operating room requires more education costs. The present invention can pre-install the clip cap with the anastomotic clip in advance. When it is needed for a second use in clinical practice, the front split clip cap can be directly replaced. The operation is simple, and it can be connected by snap-on or threaded connection, which reduces the risk of operational errors and reduces material costs.

[0027] The present invention also creatively proposes a first matching equation, a second matching equation and a third matching equation. The diameter D of the release line 4 calculated using the first matching equation, the second matching equation and the third matching equation is reduced in value, but the performance (only referring to the performance of not being easy to break) is not reduced.

[0028] Compared with release lines with diameters of 0.07 mm, 0.10 mm and 0.15 mm under the same conditions, the probability of release line breakage is reduced by 90.52%, 89.36% and 82.17% respectively, indicating that under the same conditions, the present application can effectively prevent the release line from breaking. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The accompanying drawings are used to provide a further understanding of the technical solution of the present invention and constitute a part of the specification. Together with the specific implementation methods of the present application, they are used to explain the technical solution of the present invention and do not constitute a limitation on the technical solution of the present invention.

[0030] Figure 1 It is a structural schematic diagram of the split anastomotic clip described in the present invention.

[0031] Figure 2 It is a structural schematic diagram of an embodiment of the clip applicator cap body 1 and the base 2 of the present invention.

[0032] Figure 3 It is a structural schematic diagram of another embodiment of the clip applicator cap body 1 and the base 2 of the present invention.

[0033] Figure 4 It is a structural schematic diagram of the clip applier cap body of the present invention having an O-shaped front port.

[0034] Figure 5 It is a schematic structural diagram of the clip applier cap body of the present invention having a U-shaped front port.

[0035] Figure 6 It is a schematic structural diagram of the elastic clip described in the present invention. DETAILED DESCRIPTION

[0036] The present invention is described in more detail hereinafter to facilitate understanding of the present invention.

[0037] like Figures 1 to 5 As shown, the split anastomosis clip described in the present invention includes a hollow clip cap body 1 and a release line 4, as well as a base 2 whose lower end is fixed to the front end of the endoscope. The clip cap body 1 and the base 2 are connected by a snap-on connection or a threaded connection to ensure stability and reliability; an elastic clip 5 is sleeved on the outer peripheral wall of the clip cap body 1, and the release line 4 is connected to the elastic clip 5; the release line 4 is used to switch the elastic clip 5 between a working state and an original state, and when the elastic clip 5 is in the working state, the elastic clip 5 is opened and sleeved on the outer peripheral wall of the clip cap body 1; when the elastic clip 5 is in the original state, the elastic clip 5 is detached from the clip cap body 1, so that the elastic clip 5 is released and closed, thereby clamping the diseased tissue.

[0038] Preferably, the elastic clip 5 is made of memory metal (such as nickel-titanium alloy).

[0039] like Figure 2 In the illustrated embodiment, the clip applicator cap body 1 and the base 2 are connected via a snap fastener.

[0040] like Figure 3 In the illustrated embodiment, the clip applicator cap body 1 and the base 2 are connected via threads.

[0041] Preferably, the clip applier cap body includes several types of front port types, and the front port type can be an O-shaped port or a U-shaped port to better support the endoscopic anastomotic clip. Figure 4 and Figure 5 As shown, clip applier cap bodies with O-shaped and U-shaped front ports are shown respectively.

[0042] During surgery, different models are selected for different wounds or affected areas. The O-type mouth is more universal and suitable for the entire digestive tract. The U-type mouth is for larger tissue wounds or narrow areas, such as the esophagus, duodenal bulb, and other areas where it is difficult to grab or absorb tissue. The outer and inner diameters of the two types of clip cap bodies are the same, so the size of the elastic clips assembled is the same.

[0043] like Figure 4 In the illustrated embodiment, the clip applier cap body has an O-shaped front port.

[0044] like Figure 5 In the illustrated embodiment, the clip applier cap body has a U-shaped front port.

[0045] Preferably, the front end surface of the release end of the clip applicator cap body is provided with a limiting notch 3, and the limiting notch is used to trigger the release line 4 to release the elastic clip. For the clip applicator cap body with an O-shaped or U-shaped front port, the limiting notch is respectively provided at the top of the O-shaped or U-shaped port.

[0046] Preferably, a through hole 51 is provided on the side wall of the elastic clip 5 .

[0047] like Figure 3 As shown, the first end 41 of the release line 4 passes upward from the bottom of the clamp cap body 1 into the interior of the clamp cap body 1, and passes through the top of the clamp cap body 1, and passes through the limiting notch 3 and the through hole 51 on the side wall of the elastic clip 5 in sequence. After passing through the through hole 51, the first end 41 of the release line 4 is tied on the outside of the elastic clip 5 to form a knot with the same thickness as the elastic clip 5.

[0048] Preferably, the portion of the release line 4 located between the limiting notch 3 and the through hole 51 is clamped by the elastic clip 5 between the outer peripheral wall of the clip cap body 1 and the inner side wall of the elastic clip 5 .

[0049] Preferably, the second end 42 of the release line 4 passes through the interior of the base 2 from the top of the base 2 and passes through the bottom of the base 2, enters the front end of the endoscope and passes through the side wall of the guide tube of the endoscope. By pulling the second end 42 of the release line 4, the first end 41 of the release line 4 is displaced, thereby applying sufficient force to the elastic clip 5 to disengage the elastic clip 5 from the clamp cap body 1, thereby releasing the elastic clip 5, switching the elastic clip 5 from the working state to the original state, and the elastic clip 5 is released and closed to clamp the diseased tissue.

[0050] During the operation, the diseased tissue is attracted or grasped into the clip cap body, and the anastomotic clip is released to achieve the effect of clamping the diseased tissue.

[0051] Preferably, for a clip applicator cap body having an O-shaped front port, the limiting notch 3 is arranged at the top of the O-shaped front port.

[0052] Preferably, for the clip cap body with a U-shaped front port, the U-shaped front port includes two oppositely disposed protrusions 31 and two recessed portions 32 sandwiched between the protrusions, and the limiting notch 3 is disposed at the top of one of the protrusions.

[0053] During the research and development process, the applicant unexpectedly discovered that there is a matching relationship between the material and diameter of the release line 4 and the physical parameters of the elastic clip 5. Determining the material and diameter of the release line 4 according to the matching relationship can effectively avoid the release line 4 from breaking during the pulling process of the release line 4, and reduce the value of the diameter of the release line 4. Preliminary analysis shows that the reason for the existence of this matching relationship is that the physical parameters of the elastic clip 5 directly affect the clamping force between the elastic clip 5 and the clip cap body 1, and the clamping force directly affects the friction between the elastic clip 5 and the clip cap body 1 when the elastic clip 5 is detached from the clip cap body 1. The friction is directly related to the tension applied to the release line 4, and the tension is used to cause the elastic clip 5 to detach from the clip cap body 1. If the above-mentioned tension is too large, the release line 4 will break. One of the reasons for the excessive tension is that the friction between the elastic clip 5 and the clip cap body 1 that needs to be overcome is too large, and one of the reasons for the excessive friction is that the clamping force between the elastic clip 5 and the clip cap body 1 is too large.

[0054] In order to determine the matching relationship between the material and diameter of the release line 4 and the physical parameters of the elastic clip 5, the applicant performed numerical simulation using the accumulated experimental data and Octave software. The results of the numerical simulation show that when the material of the release line 4 is polyamide, the diameter D of the release line 4 is constrained by the first matching equation, which is:

[0055]

[0056] Wherein, D represents the diameter of the release line 4, in millimeters; σ represents the initial volume number of the martensitic phase transformation of the elastic clip 5, E represents the elastic modulus of the elastic clip; and h represents the thermal conductivity coefficient of the elastic clip, in W / (m·K).

[0057] When the material of the release line 4 is polyester, the diameter D of the release line 4 is constrained by the second matching equation, which is:

[0058]

[0059] When the material of the release line 4 is polypropylene, the diameter D of the release line 4 is constrained by the third matching equation, which is:

[0060]

[0061] Preferably, when the diameter D of the release line 4 calculated by using the first matching equation, the second matching equation and the third matching equation is greater than or equal to 0.3 mm, the value of the diameter D is 0.3 mm; when the diameter D of the release line 4 calculated by using the first matching equation, the second matching equation and the third matching equation is less than or equal to 0.15 mm, the value of the diameter D is 0.15 mm.

[0062] It should be noted that since the first matching equation, the second matching equation and the third matching equation are all obtained through numerical simulation, not through mathematical deduction, the units of the physical quantities in the formula do not participate in the calculation, but only indicate the numerical value. For example, the unit of the diameter D of the release line 4 is millimeter. If the calculated diameter D is 0.3 millimeter, the unit of millimeter only indicates the numerical value of 0.3 and does not participate in the calculation. If the unit is changed to centimeter, the numerical value will become 0.03, which is inconsistent with the numerical value calculated by the first matching equation, the second matching equation and the third matching equation.

[0063] In order to verify the validity of the first matching equation, the second matching equation and the third matching equation, the applicant calculated the diameter D (D≤0.3) of the release line 4 for different elastic clips 5 using the first matching equation, the second matching equation and the third matching equation. Compared with the release line of 0.4 mm under the same conditions, the probability of the release line breaking is less than 1%, indicating that although the diameter D of the release line 4 calculated using the first matching equation, the second matching equation and the third matching equation has a reduced value, the performance (only refers to the performance that is not easy to break) has not been reduced. This also means that a thinner release line can be used under the same performance. A thinner release line means lower manufacturing costs, less impact on the endoscope, and a lower probability of damaging the patient's internal organs.

[0064] Compared with release lines with diameters of 0.07 mm, 0.10 mm and 0.15 mm under the same conditions, the probability of release line breakage is reduced by 90.52%, 89.36% and 82.17% respectively, indicating that under the same conditions, the present application can effectively prevent the release line from breaking.

[0065] The above describes the preferred embodiments of the present invention, but it is not intended to limit the present invention. Those skilled in the art may make improvements and changes to the embodiments disclosed herein without departing from the scope and spirit of the present invention.

Claims

1. A split anastomotic clip, characterized in that: The split anastomotic clip comprises a hollow clip cap body, a release line, and a base whose lower end is fixed to the front end of the endoscope. The clip cap body and the base are connected by a snap-fit ​​connection or a threaded connection to ensure stability and reliability. An elastic clip is sleeved on the outer peripheral wall of the clip cap body, and the release line is connected to the elastic clip. The release line is used to switch the elastic clip between a working state and an original state. When the elastic clip is in the working state, the elastic clip opens and sleeves on the outer peripheral wall of the clip cap body. When the elastic clip is in the original state, the elastic clip is separated from the clip cap body, so that the elastic clip is released and closed, thereby clamping the diseased tissue. A limiting notch is provided on the front end surface of the release end of the clip applicator cap body, and the limiting notch is used to activate the release line to release the elastic clip; The material of the release line is polyamide, and the diameter D of the release line satisfies the first matching equation, which is: ， Wherein, D represents the diameter of the release line, in millimeters; σ represents the initial volume number of the martensitic phase transformation of the elastic clip, E represents the elastic modulus of the elastic clip; and h represents the thermal conductivity coefficient of the elastic clip, in W / (m·K).

2. The split anastomotic clip according to claim 1, characterized in that: The clip applier cap body has an O-shaped front port.

3. The split anastomotic clip according to claim 1, characterized in that: The clip applier cap body has a U-shaped front port.

4. The split anastomotic clip according to claim 2, characterized in that: For a clip applier cap body having an O-shaped front port, the limiting notch is arranged at the top of the O-shaped front port.

5. The split anastomotic clip according to claim 3, characterized in that: For the clip cap body with a U-shaped front port, the U-shaped front port includes two relatively arranged protrusions and two recessed portions sandwiched between the protrusions, and the limiting notch is arranged on the top of one of the protrusions.

6. The split anastomotic clip according to claim 1, characterized in that: The elastic clip is made of memory metal.

7. The split anastomotic clip according to claim 1, characterized in that: The first end of the release line passes upward from the bottom of the clamp cap body into the interior of the clamp cap body, and passes through the top of the clamp cap body, and passes through the limiting notch and the through hole on the side wall of the elastic clip in sequence. After passing through the through hole, the first end of the release line is tied on the outside of the elastic clip to form a knot with the same thickness as the elastic clip.

8. The split anastomotic clip according to claim 7, characterized in that: The portion of the release line located between the limiting notch and the through hole is clamped by the elastic clip between the outer peripheral wall of the clip cap body and the inner side wall of the elastic clip.

9. The split anastomotic clip according to claim 7, characterized in that: The second end of the release line passes through the interior of the base from the top of the base and out from the bottom of the base, enters the front end of the endoscope and passes through the side wall of the guide tube of the endoscope. The first end of the release line is displaced by pulling the second end of the release line, thereby applying sufficient force to the elastic clip to disengage the elastic clip from the clip cap body, thereby releasing the elastic clip, switching the elastic clip from the working state to the original state, and the elastic clip is released and closed to clamp the diseased tissue.

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