Medical Clips
By integrating helical chamfers on the connection surfaces of medical clips, the issue of friction and twisting in the box lock area is addressed, improving measurement accuracy and reducing waste in the manufacturing process.
Patent Information
- Application Number
- JP2023526942
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-11-03
- Filing Date
- 2021-10-28
- Publication Date
- 2025-11-21
- Estimated Expiration
- 2041-10-28
AI Technical Summary
Existing medical clips, particularly aneurysm clips, face issues with measurement accuracy due to friction in the box lock area, which is exacerbated by torsional forces during clamping, leading to potential jamming and difficulty in distinguishing between compliant and non-compliant clips.
Incorporating female and/or male helical chamfers on the boundary surfaces of the connection parts to allow for line contact instead of point contact, reducing friction and twisting in the box lock area, thereby improving measurement accuracy and reducing waste.
The implementation of helical chamfers minimizes friction and twisting, enhancing the variability of spring force measurements and reducing manufacturing waste by ensuring accurate compliance with testing standards.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present invention relates to a medical clip, particularly in the form of an aneurysm clip, that includes a first clamp arm, a second clamp arm, and a biasing element having a first end and a second end. In the medical clip of the present invention, the first clamp arm has a first clamp arm end connected to a first end of the biasing element via a first connecting portion, and the second clamp arm has a second clamp arm end connected to a second end of the biasing element via a second connecting portion, the medical clip is equipped with a box lock having a coupling hole disposed or formed in the first connecting portion and a coupling portion provided in the second connecting portion and passing through the coupling hole, the first clamp arm and the second clamp arm are closest to or abutting each other in a basic position of the medical clip and are movable from the basic position to an open position so as to move away from each other against the action of the biasing element, the first clamp arm extends in a curved or bent manner from the first clamp arm end toward the free end of the first clamp arm, and the second clamp arm extends in a curved or bent manner from the second clamp arm end toward the free end of the second clamp arm, the coupling hole has two female boundary surfaces facing each other, and the coupling portion has two male boundary surfaces facing opposite each other and facing the female boundary surfaces. [Background technology]
[0002] Medical clips such as those mentioned at the beginning are known for various applications, particularly as aneurysm clips. In such medical clips, it is important that the biasing force, particularly the spring force, exerted by the biasing element has a predetermined value. To measure the spring force of an aneurysm clip, the aneurysm clip is placed in a test device and opened to a certain value in accordance with existing standards. The spring force measured in this process, also known as the closure force, must fall within certain tolerances defined by the standards. If this is not the case, the aneurysm clip must be modified or discarded as unusable.
[0003] However, one problem is that part of the tolerance is already used up by the measurement error of the testing device and the testing procedure itself. Furthermore, friction in the area of the box locks causes a significant portion of the tolerance to be lost, so in practice, the tolerance range for the testing procedure is significantly smaller than the tolerance range specified in the standard. In particular, in the case of aneurysm clips, the clamping arms of the aneurysm clip, also known as jaws, deviate from an elongated shape. That is, as mentioned above, the two clamping arms extend from the first and second clamping arm ends toward their respective free ends, for example, in an arc-like curve or angled (bent) through one or more bends. In particular, when closing the aneurysm clip, i.e., when moving the clamping arms toward each other from the open position, a torsional force is generated in the connection area of the aneurysm clip, i.e., the area where the box locks are located or formed, due to the action of the biasing element. These torsional forces twist the connection area (boxlock area) of the aneurysm clip until the male and female interface surfaces on both sides come into contact. In the case of known medical clips, this twisting is accompanied by jamming of the boxlock. This jamming of the boxlock increases friction and, in the worst case scenario, can completely exhaust the margin of error allowed in the spring force test. This, among other drawbacks, makes it impossible to clearly distinguish between medical clips that comply with the test standard and those that do not.
[0004] SUMMARY OF THE INVENTION It is therefore an object of the present invention to improve the medical clip as described above and to reduce the obstacles to measuring the closing force of a medical clip. Summary of the Invention
[0005] This object is achieved by the present invention, in which a medical clip of the type mentioned at the outset is provided with, in particular, one female helical chamfer each on each of the two female boundary surfaces and / or with, in particular, one male helical chamfer each on each of the two male boundary surfaces.
[0006] The further development proposed by the present invention allows the connection parts (first and second connection parts) to rotate, particularly in the area of the box lock, and allows the clamping arm to twist freely or almost freely. In the area of the box lock, collisions on both sides of the opposing male and female boundary surfaces can be eliminated by the helix chamfer. In contrast to conventional clips that do not have helix chamfers, in the present invention, female and / or male helix chamfers are formed on the female and / or male boundary surfaces. This means that, as a result of twisting of the clamping arm, i.e., when the edges of the coupling hole and the coupling part come into contact with each other, the point contact of the connection parts in the area of the box lock in conventional clips can be replaced by a line contact with the helix chamfer. That is, instead of edge-to-edge contact, edge-to-face contact is achieved, so that as a result of twisting, a line contact is formed instead of a point contact. Therefore, the risk of the connection portions (first and second connection portions) getting stuck (jammed) in the box lock area as a result of twisting of the clamp arm can be significantly reduced. Furthermore, the twisting of the clamp arm can also reduce friction in the box lock area. Therefore, the effect of twisting of the clamp arm on the clamp force test of the medical clip can be reduced, in particular. When twist chamfers are provided on both the female and male sides, two surfaces can abut against each other in the box lock area when the connection portions (first and second connection portions) are twisted. Therefore, compared to forming a twist chamfer on only one side of the connection area of the medical clip, i.e., forming a twist chamfer only on the female or male interface, chamfering both the female and male interface surfaces can further reduce friction in the box lock area. Such a reduction in friction has a particularly favorable effect on the variability of measurements when measuring the spring force of a medical clip, which in turn reduces waste during manufacturing.The male and / or female twist chamfers are specifically applied to the edges of the joining hole or the edges of the joining portion that pivot due to the torsional load of the clamping arm and come into point or line contact. The male and / or female twist chamfers are preferably formed only in the areas of the joining hole and the joining portion where the connecting portions (first connecting portion and second connecting portion) are located during maximum torsional moment. The areas where the male and / or female twist chamfers are formed are particularly in the positions from the fully closed state of the medical clip (i.e., the state where the clamping arms are in contact with each other) to the state where the medical clip is opened to an opening width of about 10% to about 50% of the maximum possible opening width of the medical clip, preferably about 30%.
[0007] Preferably, the two female helical chamfers run parallel to one another and / or the two male helical chamfers run parallel to one another. Such helical chamfers can be manufactured in a simple manner, for example by milling. Furthermore, such helical chamfers ensure optimal guidance of the connection parts (first and second connection parts), particularly in the area of the locking part, since, as a result of the twisting, each helical chamfer always simultaneously cooperates with the corresponding interface of the other connection part.
[0008] Preferably, only the two female interface surfaces are provided with a female helical chamfer, which minimizes friction, especially in the area of the box lock, while still providing sufficient resistance to opening of the clamping arm.
[0009] Preferably, only the two male interface surfaces are provided with male helix chamfers. This again reduces friction while still providing sufficient resistance to the opening of the clamping arms, i.e., ensuring that the clamping arms are not pushed back too far. Also, forming a male helix chamfer in a coupling is easier than forming a female helix chamfer in a coupling bore.
[0010] The two male interface surfaces may extend parallel to one another, allowing the medical clip to be formed in a simple manner. These two male interface surfaces, in particular in cooperation with female interface surfaces extending parallel to one another, can optimally guide the opening and closing of the medical clip. Here, it is particularly advantageous if the play in the area of the box lock, i.e., the distance between the cooperating male and female interface surfaces, is minimized. In particular, the box lock should be configured, if possible, so that free rotation of the connection parts (first and second connection parts) in the area of the box lock is not possible.
[0011] The connecting portion may be an elongated rectangular parallelepiped, which allows the medical clip to be manufactured in a simple manner. Such a connecting portion has, in particular, four connecting portion edges extending parallel to a longitudinal axis defined by the connecting portion. The four connecting portion edges can cooperate with the connecting portion perforation edges when the connecting portion (first connecting portion and second connecting portion) is twisted. Furthermore, the connecting portion edges can be chamfered in a simple manner.
[0012] In particular, the coupling bore may be elongated and define a coupling plane, and the two female interface surfaces may extend parallel to the coupling plane, in which case the box lock can be realized in a simple manner. In particular, such an arrangement is easy to manufacture. Furthermore, a defined pivoting of the clamping arms relative to one another can be predetermined by the thus defined coupling plane.
[0013] Advantageously, the two male boundary surfaces extend parallel or substantially parallel to the connecting plane in the basic position. In other words, the two male boundary surfaces may be oriented parallel to the female boundary surfaces, which extend parallel to each other in the basic position. This allows the pivoting movement of the clamping arm in a predefined pivot plane, which extends parallel to the connecting plane, to be predetermined.
[0014] According to a further preferred embodiment of the present invention, the first and second clamping arms are curved outward from or angled relative to the plane of attachment so that their free ends extend transversely, particularly perpendicularly, to the plane of attachment. This configuration of the clamping arms allows for a particularly wide range of application possibilities, particularly in minimally invasive applications, where aneurysms that do not form sacs transversely, particularly perpendicularly, to the longitudinal axis of the application device, but are parallel or substantially parallel to the longitudinal axis of the application device, also referred to as the application axis, can be clamped. The curvature of the clamping arms may be continuous, particularly so that the jaws defined by the two clamping arms have an arcuate configuration.
[0015] The first and second clamp arms may be continuously curved, which allows for particularly flexible application of the medical clip. For example, the radius of curvature of the two clamp arms may be constant, which allows for the formation of particularly arc-shaped clips.
[0016] Advantageously, the first clamping arm may have at least one bend arranged or formed between its free end and the first clamping arm end, and the second clamping arm may have at least one bend arranged or formed between its free end and the second clamping arm end. This type of medical clip can be used, for example, to clamp a hollow organ, in particular a blood vessel or its sac, in a defined manner distal to the bend. For example, the bend may be used to form an L-shaped jaw defined by the two clamping arms. By using two bends, a bayonet-shaped or double L-shaped (U-shaped) jaw can be realized, in particular.
[0017] Preferably, the first and second clamping arms extend parallel to one another over their entire length in the basic position, in particular when they abut against one another, which makes it possible in particular to reduce the risk of so-called "scissoring", i.e. the risk of the lateral edges of the clamping arms slipping relative to one another and leading to damage to the tissue received between the clamping arms.
[0018] Preferably, the first and second clamp arms are pivotable relative to one another about a pivot axis from a base position to a predetermined application position in which the first and second clamp arms are positioned further away from one another than the base position. This configuration allows for easy handling of the medical clip, in particular with an application instrument designed for this purpose. Furthermore, the medical clip can be opened and closed in a defined manner by moving the clamp arms away from one another and back toward one another.
[0019] The pivot axis preferably extends transversely, in particular perpendicularly, to the bonding plane. This configuration in particular minimizes the risk of the above-mentioned "scissoring." Furthermore, it allows the user to handle and in particular apply the medical clip in a regular manner. For this purpose, in particular, the application instrument may be configured so that the surgeon activates actuating elements of the application instrument that are configured to be movable relative to one another in a plane extending parallel to the bonding plane.
[0020] In order to ensure proper guidance of the connection parts (first connection part and second connection part) in the area of the box lock, it is advantageous if the female helical chamfer chamfers approximately 40% to approximately 60%, in particular approximately 45% to approximately 55%, in particular approximately 50% of the two female interface surfaces.
[0021] Furthermore, it is advantageous if the male twist chamfer is chamfered over a portion of the two male interface that is between about 40% and about 60%, in particular between about 45% and about 55%, in particular about 50%, so that an optimal guidance of the connection parts (first and second connection parts) relative to one another in the area of the box lock can be ensured, in particular as a result of twisting of the clamping arm.
[0022] The female and / or male twist chamfers may define flat, inclined surfaces, allowing the medical clip to be formed in a simple manner. Optionally, the male and / or female twist surfaces may be configured to extend without edges within their respective interfaces, allowing the medical clip to be opened and closed in a particularly delicate manner.
[0023] According to a further preferred embodiment of the present invention, the female boundary surface and the female inclined surface defined by the female twist chamfer encompass a female inclination angle, which may have a value in the range of about 5 degrees to about 25 degrees. In particular, the female inclination angle may have a value in the range of about 10 degrees to about 18 degrees, in particular about 15 degrees. By providing a female inclination angle within the above range, in particular, the configuration of the twist chamfer makes it possible to limit the maximum adverse twisting of the clamping arms relative to each other. In particular, the female inclination angle can also limit the twisting of the clamping arms relative to each other.
[0024] Furthermore, the male boundary surface and the male bevel defined by the male twist chamfer encompass a male bevel angle, which advantageously has a value in the range of about 5 to about 25 degrees, in particular in the range of about 10 to about 18 degrees. Preferably, the male bevel angle has a value of about 15 degrees. Again, the male bevel angle can limit the maximum undesirable twisting of the clamping arms relative to one another. The selected male bevel angle can also specifically limit twisting of the clamping arms relative to one another, i.e., essentially define a stop.
[0025] By having the female bevel angle match or substantially match the male bevel angle, friction in the area of the box lock can be minimized in a simple manner.
[0026] Advantageously, the female helix chamfer and / or the male helix chamfer define a curved inclined surface, so that optimal guidance of the cooperating interface and inclined surface can be achieved.
[0027] The curved inclined surface defines a line of intersection with a plane perpendicular to the female boundary surface of the first connection portion and / or a line of intersection with a plane perpendicular to the male boundary surface of the second connection portion, the line of intersection advantageously having a constant or increasing curvature extending from the female and / or male boundary surfaces. A curved inclined surface with a constant curvature may be defined, in particular, by the surface of a straight cylinder or a straight hollow cylinder. For example, a curved inclined surface with an increasing curvature may define a line of intersection forming an elliptical cross section.
[0028] Advantageously, the intersection line of the twisted chamfer defines an elliptical cross section. Such intersection line may in particular have an increasing curvature starting from the chamfered interface. In particular, it may be predetermined that, as a result of twisting of the clamping arm, the connection parts (first connection part and second connection part) move continuously relative to one another.
[0029] To minimize jamming between the edges of the cooperating male and female interfaces, the coupling perforations advantageously define four coupling perforation edges adjacent to the female interface, with two of the coupling perforation edges rotated 180 degrees relative to one another about the first longitudinal axis defined by the first connecting portion being chamfered with a female twist chamfer. The female twist chamfer configured as described above allows the connecting portions (first connecting portion and second connecting portion) to twist relative to one another. Specifically, this allows for twisting in a manner that achieves line contact instead of the point contact that occurs with conventional medical clips, which can cause jamming with very high friction. This, in particular, allows for a range of twisting of the connecting portions (first connecting portion and second connecting portion) relative to one another; even in the worst case, there is line contact between the cooperating surfaces or edges, which helps minimize friction in the area of the box lock compared to conventional medical clips.
[0030] Preferably, the connector further defines four connector edges, two of which are rotated 180 degrees relative to one another about the second longitudinal axis defined by the second connector, and are chamfered with male twist chamfers. Chamfering the male interface of the connector as described above allows the connectors (first and second connectors) to deform relative to one another as a result of twisting of the clamping portion. This, in contrast to conventional medical clips, prevents point contact between the cooperating edges of the male and female interface surfaces, allowing instead line contact between the cooperating edges and surfaces of the two connectors (first and second connectors). This prevents friction in the area of the box lock as a result of twisting forces acting on the clamping arms of the medical clip.
[0031] According to a further preferred embodiment of the invention, the two female and / or two male helical chamfers are configured to guide and limit a torsional movement of the first and / or second connecting portions relative to one another about the longitudinal axis of the corresponding first and / or second connecting portion when the first and second clamping arms are closed with a clamping object received therebetween, thereby allowing a twisting of the connections (first and second connecting portions) in the region of the box lock as a result of torsional forces acting on the clamping arms, in particular when the clamping arms are closed with a clamping object received therebetween.
[0032] Advantageously, the two male and two female boundary surfaces define straight cylindrical outer surface portions, respectively, and the longitudinal axes of the first and second connecting portions define the longitudinal axes of the corresponding cylindrical outer surface portions. In particular, the male and / or female helical chamfers may be curved and define straight cylindrical outer surface portions. This configuration can be achieved, in particular, when the connecting portion has a circular cross section and the portion of the first connecting portion defining the connecting bore also has a circular cross section. In this way, when the clamping arms are pivoted relative to each other, torsional forces do not reduce the play between the connecting bore and the connecting portion.
[0033] The outer radius of the male and female interface surfaces may be the same or substantially the same, allowing for a simpler method of forming the medical clip.
[0034] The first and / or second connecting portions, in particular the coupling holes and / or coupling portions, may be formed by generative production processes such as milling, electrochemical metal erosion, in particular 3D printing, or sink erosion, which allows the medical clip to be formed in a simple manner.
[0035] Furthermore, it may be advantageous if at least one of the male and / or female interface surfaces and the male and / or female helical chamfers is provided with a friction-reducing coating layer, which may further reduce possible friction losses, particularly in the area of the box lock. As an alternative to a friction-reducing coating layer, the cooperating connecting parts (first and second connecting parts) of the medical clip, particularly in the area of the box lock, may be made of mating materials with advantageous sliding properties.
[0036] The first clamp arm, the second clamp arm, and the biasing element are preferably formed by a generative manufacturing process, which, among other things, allows the entire medical clip to be formed by a generative manufacturing process, for example, by using a 3D printing process to manufacture the entire medical clip.
[0037] Preferably, the first and second clamping arms are biased towards each other in the basic position, which in particular helps to ensure that an object to be clamped arranged between the clamping arms can be permanently held in a clamped manner with a defined clamping force.
[0038] The biasing element may simply be configured in the form of a coil spring having at least one complete winding.
[0039] To avoid rejection of the medical clip by the patient's body, the medical clip advantageously consists of at least one biocompatible material, in particular a single biocompatible material.
[0040] Preferably, the biocompatible material is a metal such as titanium, or a plastic.The above materials can be used in a simple manner to form medical clips.
[0041] In particular, in order to be able to treat cysts on hollow organs in a defined and simple manner, the medical clip is advantageously configured in the form of an aneurysm clip.
[0042] The medical clip is preferably a one-piece, particularly monolithic, structure, and may be formed, for example, by a generative manufacturing process or from a blank. [Brief explanation of the drawings]
[0043] For further explanation, preferred embodiments of the present invention will now be described with reference to the accompanying drawings, in which:
[0044] [Figure 1] 1 is a perspective view schematically illustrating the entire medical clip and clip applier according to a first embodiment. [Figure 2] 1 is an enlarged perspective view schematically illustrating the distal end region of a clip applying instrument with a medical clip received in an open position. FIG. [Figure 3] 3 is a view of the structural portion of FIG. 2 as seen from the direction of arrow A. FIG. [Figure 4] 4 is a view similar to FIG. 3 with the hollow organ clamped. [Figure 5] 5 is a view of the structural portion of FIG. 4 as seen from the direction of arrow B. FIG. [Figure 6] FIG. 10 is a perspective view showing an entire medical clip having only a male twisted chamfer portion in another embodiment. [Figure 7] FIG. 7 is a partial enlarged view showing an area C in FIG. 6. [Figure 8] 8 shows a schematic cross-sectional view taken along line 8-8 in FIG. 7 in a state where no torsional force is applied. [Figure 9] 9 shows a schematic cross-sectional view similar to FIG. 8 in a state where a torsional force is applied. [Figure 10] 7 shows a schematic perspective view of a medical clip similar to that of FIG. 6 in another embodiment. [Figure 11] 11 is a cross-sectional view similar to FIG. 8 showing the area of the box lock in the medical clip of FIG. 10. [Figure 12] 12 is a cross-sectional view similar to FIG. 11 in a state where a torsional force is acting on the clamp arm. [Figure 13] 10 is a schematic partial view of another embodiment of a medical clip showing the area of the box lock with only a female twist chamfer. FIG. [Figure 14] 14 shows a cross-sectional view taken along line 14-14 in FIG. [Figure 15] 15 shows a schematic cross-sectional view similar to FIG. 14, but in a state where a torsional force is applied. [Figure 16] 10 is a schematic side view, partially cut away, of a medical clip according to another embodiment, showing the area of a box lock with male and female twist chamfers. FIG. [Figure 17] 17 shows a schematic cross-sectional view taken along line 17-17 in FIG. 16 in a state where no torsional force is applied. [Figure 18] 18 shows a schematic cross-sectional view similar to FIG. 17, but in a state where a torsional force is applied. [Figure 19] 10A and 10B are diagrams schematically illustrating a medical clip according to yet another embodiment. [Figure 20] FIG. 10 is a cross-sectional view showing a medical clip according to yet another embodiment. DETAILED DESCRIPTION OF THE INVENTION
[0045] 1, a clip applying system according to one embodiment is shown generally at 10. Clip applying system 10 includes an application instrument 12 and a first embodiment of a medical clip 14. Medical clip 14 is configured as an aneurysm clip 16.
[0046] The applicator 12 includes two branches 20, 22 that are pivotable relative to one another about a pivot axis 18. Tool elements 24, 26 are formed at the distal ends of the branches 20, 22. The two tool elements 24, 26 define a receiving portion 28 for receiving a proximal end region 30 of the medical clip 14.
[0047] The two branches 20, 22 are held in a home position by two cooperating leaf spring elements 32, 34. The leaf spring elements 32, 34 are disposed or formed at the proximal (base) ends of the branches 20, 22. In the home position, the two branches 20, 22 are maximally spaced or deflected from one another. Applying an actuation force to the branches 20, 22 toward one another, i.e., in the directions of arrows 36 and 38, also moves the two tool elements 24, 26 toward one another, thereby opening the medical clip 14.
[0048] The medical clip 14 includes a biasing element 40 having a first end 42 and a second end 44. In the embodiment of the medical clip 14 shown in Figures 1-5, the biasing element 40 is configured in the form of a coil spring 46 having a plurality of windings.
[0049] The medical clip 14 includes a first clamp arm 48 and a second clamp arm 50 .
[0050] First clamp arm 48 extends from a free end 54 to a first clamp arm end (proximal end) 56. Second clamp arm 50 extends from a free end 58 to a second clamp arm end (proximal end) 60.
[0051] First end 42 of biasing element 40 is connected to first clamp arm end 56 via first connector 62. Second end 44 of biasing element 40 is connected to second clamp arm end 60 of second clamp arm 50 via second connector 64.
[0052] The medical clip 14 includes a box lock 66. The box lock 66 includes a mating hole 68 and a mating portion 70 extending through the mating hole 68. The mating hole 68 is disposed or formed on the first connecting portion 62. The mating portion 70 is formed on the second connecting portion 64. The mating portion 70 is defined by the second connecting portion 64.
[0053] The first clamp arm 48 and the second clamp arm 50 are maximally adjacent to one another in the home position of the medical clip 14. In the embodiment shown in Figures 1-5, the first clamp arm 48 and the second clamp arm 50 abut one another in the home position, as shown schematically in Figure 1.
[0054] First clamp arm 48 and second clamp arm 50 can be moved away from one another from a home position to an open position against the action of biasing element 40. The medical clip 14 is shown schematically in Figures 2 and 3 in the open position.
[0055] In the medical clip 14 according to the embodiment shown in Figures 1 to 5, the first clamp arm 48 originating (extending) from the first clamp arm end 56 and the second clamp arm 50 originating (extending) from the second clamp arm end 60 have a curved shape (a bent or curved shape).
[0056] The coupling bore 68 is formed with two female boundary surfaces 72 facing each other. The two female boundary surfaces 72 therefore laterally define (separate) the coupling bore 68. The coupling portion 70 is formed with two male boundary surfaces 74 facing away from each other (in opposite directions) so as to face the female boundary surfaces 72.
[0057] The bonding perforations 68 have the shape of elongated holes and define a bonding plane (bonding reference plane) 76. The two female interface surfaces 72 extend parallel to each other and to the bonding plane 76.
[0058] In the medical clip 14 according to the embodiment shown schematically in Figures 1 to 5, the two male interface surfaces 74 are arranged in a basic position with almost no play between the two female interface surfaces 72, and each male interface surface 74 is provided with a male twist chamfer (male twist inclined portion) 78. The two male interface surfaces 74 extend parallel to each other. Similarly, the two male twist chamfers 78 extend parallel to each other.
[0059] In the basic position, the two male interface surfaces 74 extend parallel or substantially parallel to the joining plane 76 .
[0060] As is particularly apparent from FIGS. 8 and 9, approximately 50% or less of the two male interface surfaces 74 are chamfered (removed) by the male twist chamfer 78.
[0061] The male helical chamfer 78 defines a flat, inclined surface 80. The inclined surface 80 is configured to extend on both sides without intruding (interfering) with the interface 74.
[0062] The male boundary surface 74 and the corresponding beveled surface 80 of the male helix chamfer 78 define a male bevel angle 82 therebetween. The male bevel angle 82 has a value ranging from about 5 degrees to about 25 degrees. In the embodiment shown in Figures 7-9, the male bevel angle 82 is in the range of about 10 degrees to about 18 degrees. In the drawings, a male bevel angle 82 of about 15 degrees is shown.
[0063] The first clamp arm 48 and the second clamp arm 50 are curved outward (away from) the joining plane 76 or angled toward the joining plane 76 so that the free ends 54, 58 are oriented in a direction extending laterally in the basic position, specifically perpendicular to the joining plane 76 in the illustrated embodiment.
[0064] 6, the first clamp arm 48 and the second clamp arm 50 may each have a bend 84. In this case, the bend 84 is disposed or formed between the free ends 54, 58 and the first clamp arm end 56 and the second clamp arm end 60.
[0065] 1, in the basic position, the first clamp arm 48 and the second clamp arm 50 abut against each other, i.e., the first clamp arm 48 and the second clamp arm 50 extend parallel to each other over their entire lengths.
[0066] The first clamp arm 48 and the second clamp arm 50 can be moved, specifically pivoted about a pivot axis 86, from a basic position, as shown schematically in Figure 1, to an application position, as shown schematically in Figure 2. In the application position, the first clamp arm 48 and the second clamp arm 50 are spaced apart from each other compared to the basic position. The pivot axis 86 is substantially defined by the longitudinal axis of the coil spring 46, which extends transversely to the coupling plane 76, specifically vertically in the basic position.
[0067] The joint 70 defines four joint edges 88, 90, 92, 94. For example, there are initially two joint edges 90, 94 in the blank that are rotated 180 degrees relative to each other about a second longitudinal axis 96 defined by the second connecting portion 64. The two joint edges 90, 94 have been chamfered by the two male helix chamfers 78, i.e., they are no longer present.
[0068] When the medical clip 14 is received in the receiving portion 28 of the applicator 12, the tool elements 24, 26 can be moved toward each other by moving the proximal ends of the branches 20, 22 toward each other in the direction of arrows 36, 38. This causes the portions of the first and second connecting portions 62, 64 that abut the tool elements 24, 26 to move toward each other against the action of the biasing element 40. This causes the clamp arms 48, 50, whose clamping surfaces 98, 100 abutted each other in the basic position, to move away from each other. As shown schematically in the embodiment of FIGS. 1-9, the clamping surfaces 98, 100 may optionally be provided with macroscopic surface structures 102. This reduces the risk of a hollow organ 104 received between the clamp arms 48, 50 slipping out.
[0069] As shown schematically in Figures 2 and 3, the open medical clip 14 can be slid over a hollow organ 104, which is shown schematically in the form of a blood vessel 106. When the actuation force on the proximal ends of the branches 20, 22 is reduced, the leaf spring elements 32, 34 push the branches 20, 22 apart, thereby moving the tool elements 24, 26 away from each other. The medical clip 14 is urged back from the applied position toward the home position by the biasing element 40.
[0070] At this point, the medical clip 14 is no longer fully closed due to the hollow organ 104 being received between the clamping surfaces 98, 100. This means that in the clamped position shown diagrammatically in Figures 4, 6 and 9, the clamping surfaces 98, 100 do not abut each other but remain slightly apart.
[0071] The curvature of the clamping arms 48, 50 causes a torsional force to act on the clamping arms 48, 50. This torsional force is influenced by the hollow organ 104. This causes twisting of the clamping arms 48, 50, particularly in the region of the box lock 66. In particular, the spacing between the clamping arms 48, 50 increases toward the free ends 54, 58. This causes the clamping surfaces 98, 100 to no longer extend parallel to one another as in the basic position, but instead to subtend an opening angle 108 between the clamping surfaces 98, 100. The opening angle 108 is particularly smaller than the male tilt angle 82, but may have the same value as the male tilt angle 82 or may be slightly larger than the male tilt angle 82.
[0072] The provision of the box lock 66 with the male twist chamfer 78 on the male interfacing surface 74 guides and limits twisting movement of the connecting portions 62, 64 relative to one another about the first longitudinal axis 110 of the first connecting portion 62 and the second longitudinal axis 96 of the second connecting portion 64 when the clamping arms 48, 50 are closed with a clamping target 112, such as a hollow organ 104, received therebetween. In contrast to conventional medical clips, upon twisting of the connecting portions 62, 64, the connecting portion edges 90, 94 do not abut against the connecting perforation edges 114, 116, 118, 120 of the connecting perforations 68 at points, but instead form line contact between the male twist chamfer 78 and the angled surface 80 with the connecting perforation edges 116, 120. In this manner, friction in the area of the box lock of the angled (bent) or curved medical clip 14 may be reduced.
[0073] 10 to 12 schematically show a medical clip 14 according to another embodiment. The medical clip 14 in FIGS. 10 to 12 has a structure similar to that of the medical clip 14 in FIGS. 6 to 9. In the medical clip 14 in FIGS. 10 to 12, the free ends 54, 58 of the clamp arms 48, 50 are bent in the opposite direction relative to the bonding plane 76 as compared to the free ends 54, 58 of the clamp arms 48, 50 of the medical clip 14 in FIGS. 6 to 9. That is, the free ends 54, 58 of the clamp arms 48, 50 face in the opposite direction compared to the free ends 54, 58 of the clamp arms 48, 50 of the medical clip 14 in FIGS. 6 to 9.
[0074] The reference numerals used in FIGS. 10-12 correspond to the reference numerals used in connection with the medical clip 14 according to the embodiment of FIGS.
[0075] A comparison of Figures 6 and 10 reveals that the two medical clips 14 shown therein are mirror images of each other. While this does not ultimately change the function of the medical clip 14, it does necessitate the formation of male twist chamfers 78 at other joint edges of the joint 70, namely, joint edges 88 and 92. This is because, in the embodiment shown in Figure 10, a clamping target 112 received between clamping surfaces 98 and 100 causes twisting motion of the joint 70 about the second longitudinal axis 96 in a direction opposite to the twisting motion of the joint 70 in the embodiment of Figures 6-9.
[0076] In the two medical clips 14 according to the embodiment of Figures 6-9 and the embodiment of Figures 10-12, the configuration of the male twist chamfer 78, by way of example, demonstrates that the following is possible: The male interface 74, i.e., the joining edge, is chamfered to allow the connecting portions 62, 64 to twist relative to one another by the male bevel angle 82, which would otherwise cause jamming in conventional medical clips. That is, the connecting portions 62, 64 are allowed to twist relative to one another in a manner that allows for line contact rather than point contact between the connecting portions 62, 64.
[0077] 13-15 show a schematic representation of a portion of a medical clip 14 according to a further embodiment. This embodiment differs from the embodiment of FIGS. 6-9 only in the configuration of the box lock 66. For all other features of the medical clip 14, reference is made to the above description in connection with FIGS. 1-9. Accordingly, the same reference numerals are used to denote the same or equivalent elements and components.
[0078] 13 to 15, only two female-side boundary surfaces 72 are provided with female-side twist chamfered portions (female-side twist inclined portions) 122. These two female-side twist chamfered portions 122 extend parallel to each other.
[0079] If the female twist chamfer 122 were not present, four joining perforation edges 114, 116, 118, 120 that contact the female boundary surface 72 would be defined (formed) in the joining perforation 68. In the embodiment illustrated in Figures 13-15, the joining perforation edges 114, 118 are chamfered by the female twist chamfer 122. The two female twist chamfers 122 are positioned at positions rotated 180 degrees relative to each other about the first longitudinal axis 110 defined by the first connecting portion 62.
[0080] The female interface 72 and the female bevel 124 defined by the female helix chamfer 122 encompass a female bevel angle 126 having a value within a range of about 5 degrees to about 25 degrees. In one embodiment, the value of the female bevel angle 126 is within a range of about 10 degrees to about 18 degrees. In the illustrated embodiment, the female bevel angle 126 is about 15 degrees.
[0081] The female twist chamfer 122 is dimensioned so that a maximum of approximately 50% of the two opposing female interface surfaces 72 is chamfered (removed) by the female twist chamfer 122 .
[0082] The female-side inclined surface 124 has a planar shape (flat surface). The female-side inclined surface 124 extends without entering (interfering with) the female-side boundary surface 72.
[0083] 13-15 correspond in function to the medical clip 14 of the embodiment described in detail in connection with Figures 10-12. The provision of the female twist chamfer 122 as described above allows twisting of the connecting portions 62, 64 relative to one another about the first longitudinal axis 110. This allows for line contact between two of the connecting portion edges 88, 90, 92, 94 and the two female angled surfaces 124 of the female twist chamfer 122, instead of point contact between adjacent edges of the connecting portion 70 and the connecting perforation 68.
[0084] A portion of a medical clip 14 according to yet another embodiment is shown schematically in Figures 16 to 18. The structure of the medical clip 14 in Figures 16 to 18 corresponds to the medical clip 14 in Figures 10 to 12, but the configuration of the box lock 66 is different.
[0085] In the embodiment of Figures 16-18, the coupling portion 70 is configured to correspond to the coupling portion 70 of the embodiment of Figures 10-12. In this embodiment, the coupling bores 68 are configured to correspond to the coupling bores 68 of the embodiment of Figures 13-15. This allows twisting about both longitudinal axes 96, 110, rather than just one of them. By chamfering both the female interface 72 and the male interface 74, the clamping arms 48, 50 are free to twist. This eliminates collisions between the connectors 62, 64 on either side of the box lock 66 area. However, to compensate for this twisting, the medical clip 14 must also be oriented more distally, i.e., toward the free ends 54, 58 of the clamping arms 48, 50. However, such an orientation results in a significant loss of the desired opening width of the medical clip 14.
[0086] Yet another embodiment of a medical clip 14 is shown schematically in Figure 19. This medical clip 14 is very similar to the embodiment of Figures 7-9, differing only in the configuration of the male beveled surface 80. Unlike the embodiment of Figures 7-9, the male beveled surface 80 in Figure 19 is curved rather than flat.
[0087] The curved inclined surface 80 defines (forms) an intersection line 128 with a plane of intersection at the second mating portion 64 that is perpendicular to the male interface surface 74. The intersection line 128 has an increasing curvature beginning at the male interface surface 74. In an alternative embodiment (not shown), the curvature may be constant.
[0088] In the embodiment shown in FIG. 19, the intersection line 128 of the male twist chamfer 78 defines an elliptical cross section.
[0089] A further embodiment of a medical clip 14 is shown in the cross-sectional view of Figure 20. The medical clip 14 corresponds in structure to the medical clip 14 shown schematically in Figures 1 to 9, but the box lock 66 is configured differently.
[0090] In this embodiment, the male interface 74 and the female interface 72 define straight cylindrical outer surface sections. The longitudinal axes 96, 110 of the connecting portions 62, 64 define the longitudinal axes of the corresponding outer cylindrical surfaces, respectively. In the embodiment shown in FIG. 20, all torsion-related contact edges of the two connecting portions 62, 64 are chamfered in the area of the box lock 66, i.e., all contact edges are provided with curved inclined surfaces. This configuration ensures that pivoting of the clamping arms 48, 50 relative to one another, i.e., particularly torsionally, does not reduce the play between the coupling bore 68 and the coupling portion 70.
[0091] In the embodiment shown in FIG. 20, the outer radii of the male interface 74 and the female interface 72 are the same.
[0092] The connection portions 62, 64 of the medical clip 14 according to the above embodiments, i.e., in particular the bonding perforations 68 and / or bonding portions 70 in the connection portions 62, 64, are formed by a generative production process, such as, for example, milling, electrochemical metal erosion, in particular 3D printing, or by sink erosion.
[0093] In a further embodiment structurally corresponding to the medical clip 14 of the above embodiment, the male interface surface 74 and / or the female interface surface 72, and the male twist chamfer 78 and / or the female twist chamfer 122 may be provided with a friction-reducing coating layer.
[0094] In the above embodiments of the medical clip 14, the first clamp arm 48, the second clamp arm 50, and / or the biasing element 40 may be formed by a generative manufacturing process. In particular, in the above embodiments, the entire medical clip 14 may be formed by a generative manufacturing process.
[0095] The above medical clip 14 may be particularly configured such that the first clamp arm 48 and the second clamp arm 50 are biased toward each other in the home position.
[0096] The medical clip 14 according to the above embodiments may be made of a biocompatible material.
[0097] The medical clip 14 according to the above embodiments may be particularly integrally formed, in which case the medical clip 14 may be made of only a single biocompatible material.
[0098] In the above embodiments, the biocompatible material may be a metal, such as titanium, or a plastic.
[0099] In a further embodiment of the medical clip (not shown), a pretwisted joint is provided in the form of a box lock. In this embodiment, the female and male interface surfaces of both the joint drilling and the joint are not chamfered; that is, no twist chamfer is provided. In this embodiment, the pretwist in the pretwisted joint is set so that the angular range of the pretwist corresponds to the angular range of the twist chamfer provided in the medical clip 14 described above. As a result of the pretwist of the joint set in this way, at the measurement point (i.e., when the medical clip is slightly opened to measure the spring force), the pretwist is offset by a twist acting in the opposite direction.
[0100] The targeted application of the twist chamfer 78 and / or twist chamfer 122 described above in connection with the medical clip 14 of the above embodiments constitutes an effective means for reducing friction in the region of the boxlock 66. As noted above, this is particularly advantageous in aneurysm clips 16 having clamping arms 48, 50 that are curved or bent one or more times, also referred to as laterally deflected jaws, to absorb torsional moments when positioned against a clamping target 112. The reduced friction provided by the boxlock 66 modifications has a positive effect on the variability of measurements of spring force, i.e., the force exerted by the biasing element 40, thereby reducing waste in the manufacture of such medical clips. That is, the boxlock 66 geometry modifications can reduce the number of medical clips 14 whose clamping or spring force does not fall within the tolerances set by the test standard. [Explanation of symbols]
[0101] 10 Clip Application System 12 Applicable equipment 14 Medical Clips 16 Aneurysm Clips 18 Swivel Axis 20 Branch Department 22 Branch Department 24 Tool Elements 26 Tool Elements 28 Reception Department 30 End area 32 Leaf spring element 34 Leaf spring element 36 Arrow 38 Arrow 40. Actuation element 42 First end 44 Second end 46 Coil spring 48 First clamp arm 50 Second clamp arm 54 Free end 56 End of first clamp arm 58 Free end 60 End of second clamp arm 62 First connection part 64 Second connection part 66 Boxlock 68 Combined perforation 70 Joint 72 Female side boundary surface 74 Male side interface 76 Join plane 78 Male side twisted chamfer 80 Male side slope 82 Male side inclination angle 84 Bend 86 Swivel axis 88 Joint Edge 90 Joint Edge 92 Joint Edge 94 Joint Edge 96 Second Longitudinal Axis 98 Clamping surface 100 Clamping surface 102 Surface structure 104 Hollow organ 106 Blood vessels 108 Opening angle 110 first longitudinal axis 112 Clamp target 114 Bonded Perforated Edge 116 Bonded Perforated Edge 118 Bonded Perforated Edge 120 Bonded Perforated Edge 122 Female side twisted chamfer 124 Slope 126 Female side inclination angle 128 Intersection line
Claims
1. A medical clip (14) comprising a first clamp arm (48), a second clamp arm (50), and a biasing element (40) having a first end (42) and a second end (44), the first clamp arm (48) has a first clamp arm end (56) connected to the first end (42) of the biasing element (40) via a first connection (62); the second clamp arm (50) has a second clamp arm end (60) connected to the second end (44) of the biasing element (40) via a second connection portion (64); The medical clip (14) includes a box lock (66) having a coupling hole disposed or formed in the first connecting portion (62) and a coupling portion (70) provided in the second connecting portion (64) and passing through the coupling hole; the first clamp arm (48) and the second clamp arm (50) are closest to or abut one another in a home position of the medical clip (14), and are movable from the home position to an open position so as to move away from one another against the action of the biasing element (40); The first clamp arm (48) extends in a curved or bent manner from the first clamp arm end (56) toward the free end (54) of the first clamp arm (48); The second clamp arm (50) extends while curving or bending in a direction from the second clamp arm end (60) toward the free end (58) of the second clamp arm (50); The coupling bore (68) is formed with two opposing female interface surfaces (72), The coupling portion (70) is formed with two male boundary surfaces (74) facing opposite to each other and facing the female boundary surface (72), A medical clip characterized in that the two female interface surfaces (72) are each provided with a female helical chamfer (122) and / or the two male interface surfaces (74) are each provided with a male helical chamfer (78).
2. 2. The medical clip of claim 1, wherein the two female helical chamfers (122) extend parallel to each other and / or the two male helical chamfers (78) extend parallel to each other.
3. (a) A configuration in which only the two female boundary surfaces (72) are provided with female twisted chamfers (122); (b) a configuration in which only the two male boundary surfaces (74) are provided with male twisted chamfers (78); 3. The medical clip according to claim 1 or 2, comprising at least one configuration.
4. (a) the two male interface surfaces (74) extend parallel to each other; (b) The coupling portion (70) is an elongated rectangular parallelepiped.
4. The medical clip according to claim 1, further comprising at least one structure.
5. The coupling bore (68) is elongated and defines a coupling plane (76); The two female interface surfaces (72) extend parallel to the joining plane (76). The medical clip according to any one of claims 1 to 4.
6. (a) the first clamp arm (48) and the second clamp arm (50) are configured to be continuously curved; (b) the first clamp arm (48) has at least one bend (84) disposed or formed between the free end (54) and the first clamp arm end (56), and the second clamp arm (50) has at least one bend (84) disposed or formed between the free end (58) and the second clamp arm end (60); (c) the first clamp arm (48) and the second clamp arm (50) extend parallel to each other over their entire lengths in the basic position; 6. The medical clip according to claim 1, comprising at least one configuration.
7. the first clamp arm (48) and the second clamp arm (50) are pivotable relative to each other about a predetermined pivot axis (86) from the basic position to a predetermined application position; In the application position, the first clamping arm (48) and the second clamping arm (50) are positioned further away from each other compared to the basic position. The medical clip according to any one of claims 1 to 6.
8. (a) The female twisted chamfered portion (122) chamfers 40% to 60% of the two female boundary surfaces (72); (b) the male side twisted chamfered portion (78) chamfers 40% to 60% of the two male side boundary surfaces (74); (c) the female helical chamfer (122) and / or the male helical chamfer (78) define a flat, inclined surface (80, 124); 8. The medical clip according to claim 1, comprising at least one configuration.
9. (a) the female boundary surface (72) and the female inclined surface (124) defined by the female twisted chamfer (122) encompass a female inclination angle (126), and the female inclination angle (126) has a value within a range of 5 degrees to 25 degrees; (b) the male side boundary surface (74) and the male side inclined surface (80) defined by the male side twisted chamfer (78) encompass a male side inclination angle (82), the male side inclination angle (82) having a value within the range of 5 degrees to 25 degrees, 9. The medical clip according to claim 1, comprising at least one configuration.
10. the female helical chamfer (122) and / or the male helical chamfer (78) define a curved, inclined surface (80, 124); The medical clip according to any one of claims 1 to 9.
11. the curved inclined surface (80, 124) defines an intersection line (128) with a plane perpendicular to the female boundary surface (72) of the first connection portion (62) and / or an intersection line (128) with a plane perpendicular to the male boundary surface (74) of the second connection portion (64); the intersection line (128) has a constant or increasing curvature extending from the female interface (72) and / or the male interface (74); The medical clip according to claim 10.
12. (a) the joining perforation (68) defines four joining perforation edges (114, 116, 118, 120) adjacent the female interface surface (72), two of the joining perforation edges (114, 118) rotated 180 degrees relative to one another about a first longitudinal axis (118) defined by the first connecting portion (62) being chamfered by the female helix chamfer (122); (b) the coupling portion (70) defines four coupling edges (88, 90, 92, 94), two of the coupling edges (90, 94) rotated 180 degrees relative to one another about a second longitudinal axis (96) defined by the second connecting portion (64) being chamfered by the male helix chamfer (78); 12. The medical clip according to any one of claims 1 to 11, comprising at least one feature.
13. the two female helical chamfers (122) and / or the two male helical chamfers (78) are configured to guide and limit torsional movement of the first connecting portion (62) and the second connecting portion (64) relative to each other about the longitudinal axis (96, 110) of the corresponding first connecting portion (62) and / or the corresponding second connecting portion (64) when the first clamping arm (48) and the second clamping arm (50) are closed with a clamping object (112) received between the first clamping arm (48) and the second clamping arm (50). The medical clip according to any one of claims 1 to 12.
14. the two male boundary surfaces (74) and the two female boundary surfaces (72) each define a straight cylindrical outer surface portion; the longitudinal axes (96, 110) of the first connecting portion (62) and the second connecting portion (64) respectively define the longitudinal axes of the corresponding cylindrical outer surface portions; The medical clip according to any one of claims 1 to 13.
15. (a) a friction-reducing coating layer is provided on at least one of the male boundary surface (74) and / or the female boundary surface (72) and the male twisted chamfered portion (78) and / or the female twisted chamfered portion (122); (b) the first clamping arm (48), the second clamping arm (50), and / or the biasing element (40) are formed by a generative manufacturing process; (c) the first clamp arm (48) and the second clamp arm (50) are biased toward each other in the basic position; (d) the biasing element (40) is configured in the form of a coil spring (46) having at least one complete winding; (e) the medical clip (14) is constructed from at least one biocompatible material; (f) the medical clip (14) is configured in the form of an aneurysm clip (16); 15. The medical clip of any one of claims 1 to 14, comprising at least one feature.
Citation Information
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