CN114533208B - Puncture sheath and bending-adjustable system - Google Patents
Puncture sheath and bending-adjustable system Download PDFInfo
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- CN114533208B CN114533208B CN202011334680.2A CN202011334680A CN114533208B CN 114533208 B CN114533208 B CN 114533208B CN 202011334680 A CN202011334680 A CN 202011334680A CN 114533208 B CN114533208 B CN 114533208B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
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Abstract
The invention relates to a puncture sheath and an adjustable bending system. The puncture sheath includes a puncture portion, a flexible portion, and a support portion. Wherein, the both ends of flexible portion link to each other with puncture portion and supporting part respectively, and the bending property of flexible portion is higher than the bending property of supporting part. The puncture sheath has better bending performance and can be well adapted to the bending form of the lumen. And when this puncture sheath and adjustable curved sheath pipe are used together, because the bending property of flexible portion is better, need not to withdraw from puncture sheath before the accent bending, convenient operation is favorable to improving operating efficiency.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a puncture sheath and an adjustable bending system.
Background
This section provides merely background information related to the present disclosure and is not necessarily prior art.
At present, interventional diagnosis and treatment sheath and catheter are widely applied to human interventional diagnosis and treatment operation, and a channel between a lesion site and an external operation end in a patient body is generally established by means of interventional diagnosis and treatment sheath and catheter with various structures, shapes and sizes so as to introduce various diagnosis and treatment instruments, medicines or implantation instruments to the lesion site of the patient or to lead out body fluid and the like of the lesion site, thereby achieving the purpose of avoiding the use of surgical operation and reaching the lesion site. The sheath typically includes a body that is relatively long and has an interior cavity for passage therethrough, and a handle that has a distal end that facilitates access to a body lumen (e.g., a blood vessel) and a proximal end that is adapted to be coupled to the handle for manipulation by an operator. For example: guide catheters, delivery sheaths, guide sheaths, and the like. In use, the distal end of the sheath is typically inserted into a blood vessel and the tube is then advanced to a predetermined location (e.g., lesion) at the distal end, through the lumen of the sheath, and through the drug, body fluid, or instrument. The larger the diameter of the inner cavity of the tube body is, the easier the delivery of the instruments and the medicines is, and the smaller the outer diameter of the tube body is, the smaller the trauma to the lumen of the human body is.
The operator generally needs to send the distal end of the sheath to a predetermined position by external manipulation of the handle under the guidance of medical imaging equipment such as an X-ray machine. Because the pipeline in the human body has the characteristic of tortuous and the influence of remote operation from outside the receptor to inside the human body, the operation that the distal end of the sheath reaches the preset position in the human body is difficult, and therefore the application range of the minimally invasive interventional sheath technology is limited.
In addition, in the design and manufacturing process of the sheath, the distal end of the sheath is preformed into different bending shapes according to different expected uses of the sheath, so that the distal end of the sheath is matched with the anatomical morphology of a specific lesion, and the distal end of the sheath is conveniently aligned to the lesion in a human body. In recent years, distal pre-shaped interventional medical sheaths of various shapes and angles have been developed and put into clinical use. This requires that the warehouse of the hospital must stock all the shape and size of the sheath, which undoubtedly increases the stock size and number of the hospital and increases the use cost of the hospital. However, even if distal pre-shaped interventional sheath of various shapes and angles were developed, the following frequently occur in clinical use: when the individual difference occurs in the physiological anatomy structure of the human body, even the distal end pre-shaping sheath tube designed according to the specific physiological anatomy structure of the human body cannot be adapted to the individual physiological anatomy structure one by one, so that the operation effect is affected. When such problems occur during surgery, the physician typically withdraws the sheath and reselects the preformed sheath of another shape, which undoubtedly increases the costs incurred by the patient, increases the chances of damage to the patient's luminal tissue, and correspondingly increases the patient's exposure time. In addition, at the operation site, the distal end of the sheath is sometimes reshaped into a desired general shape by heat treatment according to the physiological anatomy of the patient, but this is not an operation skill that can be grasped by every doctor, and such reshaping operation may cause damage to the sheath, such as breakage, lumen loss, etc. In addition, the sheath tube can accurately reach the lesion site with the help of a guide wire and a dilator, and the guide wire can easily enter the lesion site due to the soft characteristic of the guide wire; the preformed dilator is inserted into the lumen of the tube body and the sheath and dilator are forced by the guidewire to point to a predetermined location as they are advanced along the guidewire and reach the lesion. However, after the dilator and guidewire are withdrawn from the sheath, the distal end of the sheath will not retain the original pre-shaped form, thereby biasing the distal end of the sheath away from the predetermined position. In this process, the sheath first provides a torsion force to the guidewire, and a repulsive force occurs to the sheath after the guidewire is withdrawn, and both of the forces may cause damage to the tissue surrounding the predetermined location.
Based on the above situation, a sheath distal end bending adjustable technology is developed at present, and the sheath distal end can be repeatedly changed between different angles through in-vitro adjusting operation so as to adapt to different physiological anatomy forms.
The operation mode of the currently commonly used adjustable bending sheath in clinic is that after the adjustable bending system is conveyed to a preset position, the puncture sheath is withdrawn so that the puncture sheath is not positioned in the adjustable bending area of the sheath tube, then the angle of the sheath tube is adjusted, and the sheath tube is pushed to the preset position after the angle is adjusted, or other medical instruments, medicines or implantation instruments are delivered to the lesion site of a patient. However, in the clinical operation process, each time when the angle adjustment is performed on the sheath, the puncture sheath is withdrawn from the sheath bending-adjustable region, so that the operation is troublesome, and if the doctor carelessly withdraws the puncture sheath in time in the angle adjustment process of the sheath in the operation process, the failure of the angle adjustment of the sheath or the failure of the instrument product is likely to be caused, and the operation efficiency of the clinician is affected.
Disclosure of Invention
Based on this, it is necessary to provide a puncture sheath that can adapt to the curved shape of the lumen and is advantageous for improving the efficiency of the operation.
Further, an adjustable bend system is provided.
The puncture sheath comprises a puncture part, a flexible part and a supporting part, wherein two ends of the flexible part are respectively connected with the puncture part and the supporting part, and the bending performance of the flexible part is higher than that of the supporting part.
In one embodiment, the axial length of the support portion is 75% -90% of the total axial length of the puncture sheath.
In one embodiment, the flexible portion includes a plurality of axially spaced ring members.
In one embodiment, adjacent annular members are connected by an axial connecting member, and hollow parts are arranged between the adjacent annular members.
In one embodiment, the puncture sheath further comprises a reinforcing member, adjacent annular members are connected through an axial connecting member, a hollowed-out portion is arranged between the adjacent annular members, and the hollowed-out portion is filled with the reinforcing member.
In one embodiment, the flexible portion further includes a connecting tube, and the plurality of ring members are sleeved on the connecting tube at intervals along the axial direction.
In one embodiment, the flexible portion includes a connection tube and a helical hook wound around the connection tube.
In one embodiment, the flexible portion and the supporting portion are of a non-hollowed-out lumen structure, and the flexibility of the flexible portion is greater than that of the supporting portion.
In one embodiment, the flexible portion and the support portion are of the same material and the wall thickness of the flexible portion is less than the wall thickness of the support portion such that the flexibility of the flexible portion is greater than the flexibility of the support portion;
Or the hardness of the flexible portion is smaller than that of the supporting portion, so that the flexibility of the flexible portion is greater than that of the supporting portion.
In one embodiment, the flexible portion includes a base material and a conditioning material doped in the base material, the base material being the same as or different from the material of the support portion, the conditioning material being configured to enhance flexibility of the flexible portion such that the flexible portion is greater than the flexibility of the support portion.
In one embodiment, the puncture sheath further comprises a transition portion, wherein the transition portion is located between the puncture portion and the flexible portion, one end of the transition portion is connected with the puncture portion, and the other end of the transition portion is connected with the flexible portion.
A bending-adjustable system comprises a bending-adjustable assembly and the puncture sheath, wherein the bending-adjustable assembly comprises a bending-adjustable sheath tube, and at least part of the puncture sheath tube is movably accommodated in the bending-adjustable sheath tube.
In one embodiment, the adjustable bend sheath includes an adjustable bend, the flexible portion having an axial length that is not less than an axial length of the adjustable bend such that the adjustable bend opposes the flexible portion when at least a portion of the puncture sheath is received in the adjustable bend sheath.
According to the puncture sheath, the flexible part with higher bending performance than the supporting part is arranged between the puncture part and the supporting part, so that the puncture sheath has better bending performance and can be well adapted to the bending form of the lumen. And when this puncture sheath and adjustable curved sheath pipe are used together, because the bending property of flexible portion is better, need not to withdraw from puncture sheath before the accent bending, convenient operation is favorable to improving operating efficiency.
Drawings
FIG. 1 is a schematic diagram of an embodiment of a bending-adjustable system;
FIG. 2 is a schematic view of the structure of a puncture sheath according to an embodiment;
FIG. 3 is a schematic view of the structure of the flexible portion of the puncture sheath according to an embodiment;
FIG. 4 is a schematic view showing a bending state of the puncture sheath according to an embodiment;
FIG. 5 is a schematic view of the structure of the flexible portion of the puncture sheath according to another embodiment;
FIG. 6 is a schematic view of the flexible portion of a lancing sheath according to yet another embodiment;
FIG. 7 is a schematic view of another embodiment of a puncture sheath
FIG. 8 is a schematic view of the structure of a puncture sheath according to yet another embodiment;
FIG. 9 is a schematic diagram of an exemplary embodiment of an adjustable bend assembly;
FIG. 10 is a schematic diagram of a bending state of an embodiment of a bending adjustable system;
fig. 11 is a schematic diagram of an application scenario of a bending-adjustable system according to an embodiment.
Detailed Description
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit or scope of the invention, which is therefore not limited to the specific embodiments disclosed below.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
In the field of interventional medical devices, "distal" is defined as the end of the procedure that is distal to the operator, and "proximal" is defined as the end of the procedure that is proximal to the operator. "axial" refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device, and "radial" refers to a direction perpendicular to the axial direction.
Referring to fig. 1, an embodiment of a bending-adjustable system 100 includes a puncture sheath 10 and a sheath bending-adjustable assembly 20. The adjustable bend sheath assembly 20 includes an adjustable bend sheath tube 210, at least a portion of the puncture sheath 10 being movably received in the adjustable bend sheath tube 210. That is, the penetrating sheath 10 may extend into the adjustable curved sheath 210 and may be axially movable along the adjustable curved sheath 210 or withdrawn from the adjustable curved sheath 210.
Referring to fig. 2, the puncture sheath 10 includes a puncture section 110, a flexible section 120, and a support section 130. The piercing portion 110, the flexible portion 120, and the supporting portion 130 are sequentially arranged in the axial direction, and both ends of the flexible portion 120 are connected to the piercing portion 110 and the supporting portion 130, respectively.
The puncturing part 110 has a hollow tapered structure with openings at both ends, and one end of the puncturing part 110, which is far away from the flexible part 120, has a pointed structure to facilitate puncturing. In addition, the puncture part 110 has a tapered structure, and the outer diameter of the puncture part 10 gradually increases from the distal end to the proximal end, so that the puncture part 110 has a puncture performance and also has better flexibility, thereby being beneficial to passing through a curved lumen, such as a curved blood vessel.
Referring to fig. 3, in one embodiment, the flexible portion 120 includes a plurality of axially spaced ring members 122. In one embodiment, adjacent ring members 122 are connected by an axial connection member 124, and hollow portions are provided between the adjacent ring members 122, so as to form a hollow lumen structure. The flexible portion 120 of this structure is superior in flexibility and thus bending property.
In one embodiment, adjacent ring members 122 are connected by two axial connectors 124, the two axial connectors 124 being symmetrically disposed about the central axis of the ring member 122. And, all of the axial connectors 124 on the same side of the central axis of the ring 122 are on the same line. By this arrangement, when the flexible portion 120 is bent in a specific direction, no axial connectors 124 are located on the large-bending side a and the small-bending side B of the flexible portion 120, as shown in fig. 4, so that the bending performance of the flexible portion 120 is better.
The shape of the axial connector 124 is not limited, and may be, for example, a straight rod, an arc-shaped rod, a special-shaped rod, or the like.
The ring 122 and the axial connector 124 are of unitary construction, such as integrally formed unitary construction by injection molding. Or the ring 122 and the axial connector 124 may be connected by a connection known to those skilled in the art, such as welding, glue bonding, etc.
Referring back to fig. 3, in an embodiment, the flexible portion 120 further includes a reinforcing member 126, and the reinforcing member 126 fills the hollowed-out portion between the adjacent annular members 122, so that the flexible portion 120 is a non-hollowed-out lumen structure. Also, the outer peripheral surface of the reinforcing member 126 is lower than the outer peripheral surface of the annular member 122 in the radial direction, i.e., the distance from the outer peripheral surface of the reinforcing member 126 to the central axis of the annular member 122 is smaller than the radius of the annular member 122. The reinforcing piece 126 is arranged, so that the pushing performance of the flexible part 120 is considered while the flexible part 120 has certain flexibility, and the whole puncture sheath 10 has proper pushing performance so as to facilitate puncture.
The reinforcement members 126 are connected to the ring member 122 and the axial connector 124 by means known to those skilled in the art, such as welding, glue bonding, etc. Or the reinforcement member 126, the ring member 122, and the axial connector 124 may be formed as a unitary structure, such as by injection molding. In the injection molding process, the reinforcement 126 is subjected to a gel-reducing process such that the distance from the outer circumferential surface of the reinforcement 126 to the central axis of the ring 122 is smaller than the radius of the ring 122, and the inner wall of the flexible portion 120 is smooth to smoothly advance along the guide wire in the body cavity.
In an embodiment, the inner wall of the reinforcement member 126 and the inner wall of the annular member 122 are located on the same curved surface, and the ratio of the wall thickness of the reinforcement member 126 to the wall thickness of the annular member 122 is 1/3-1/2, so as to better combine the bending performance and pushing performance of the flexible portion 120.
In an embodiment, when the flexible portion 120 further includes the reinforcement member 126, the adjacent annular members 122 are connected by only one axial connection member 124, so that the bending performance of the flexible portion 120 is better, and meanwhile, due to the reinforcement member 126, the pushing performance of the flexible portion 120 can be ensured.
In one embodiment, when the flexible portion 120 further includes the reinforcement member 126, adjacent ring members 122 are connected by only one axial connector 124, and all of the axial connectors 124 are circumferentially spaced apart in a cross section of the flexible portion 120 (a cross section perpendicular to a longitudinal center axis of the flexible portion 120). This arrangement allows the introducer sheath 10 to be inserted into the adjustable bend sheath 210 in any orientation during use without orientation.
In one embodiment, as shown in fig. 5, the axial connecting member 124 and the reinforcing member 126 are omitted, and the flexible portion 120 includes a connecting tube 125 and a plurality of ring members 122 sleeved on the connecting tube 125, where the plurality of ring members 122 are spaced apart. The flexible portion 120 of such an embodiment is more flexible and has better bending properties. Moreover, the connecting tube 125 is a non-hollow lumen structure, so as to consider the pushing performance of the flexible portion 120.
In one embodiment, the connecting tube 125 and the plurality of ring members 122 are non-integral structures, and the plurality of ring members 122 are fixed to the surface of the connecting tube 125 by means of fixing methods known to those skilled in the art, such as gluing, welding, etc.
In one embodiment, the connecting tube 125 and the plurality of ring members 122 are integrally formed, such as by injection molding.
Whether or not the flexible portion 120 includes the axial connectors 124 and the reinforcement 126, the plurality of ring members 122 may be equally spaced or unequally spaced.
Referring to fig. 6, in one embodiment, the axial connector 124 and the reinforcement 126 are omitted, and the flexible portion 120 includes a connection tube 125 and a spiral member 123 wound around the connection tube 125. The spiral member 123 may be fixed to the connection pipe 125 by welding or gluing, etc. Or the spiral member 123 and the connection pipe 125 are integrally formed. The connecting tube 125 is a non-hollowed-out lumen structure, and the flexible part 120 comprising the connecting tube 125 and the spiral member 123 has better bending performance and pushing performance.
In one embodiment, the wall thickness of the connection tube 125 is smaller than the wall thickness of the support tube 130, the inner surface of the connection tube 125 and the inner surface of the support tube 130 are located on the same curved surface, and the outer diameter of the flexible portion 120 is equal to the outer diameter of the support tube 130.
In one embodiment, the wall thickness of the connection tube 125 is 1/4-3/4 of the wall thickness of the support tube 130, the spiral member 123 is in a sine wave or Z wave structure, the spiral member 120 axially extends from the distal end to the proximal end of the connection tube 125, and the wave width of each sine wave or Z wave is 1/5-1/20 of the axial length of the connection tube 125, so that the bending performance and pushing performance of the flexible portion 120 are better.
Referring to fig. 7, in another embodiment, the flexible portion 120 is a non-hollow lumen structure, and the flexible portion 120 is a lumen structure with smooth inner and outer surfaces.
Whether the flexible portion 120 is a hollowed-out lumen structure or a non-hollowed-out lumen structure, in an embodiment, as shown in fig. 2, the axial length L1 of the flexible portion 120 is 10% -20% of the total axial length L of the puncture sheath 10, so as to ensure bending performance and pushing performance. In another embodiment, the axial length L1 of the flexible portion 120 is 5% -15% of the total axial length L of the puncture sheath 10 to ensure bending and pushing properties.
In an embodiment, the material of the flexible portion 120 is a polymer material, such as Polyethylene (PE), block polyether amide elastomer (Pebax), polypropylene (PP), or the like.
The flexible portion 120 of the different embodiments shown in fig. 2, 5,6 and 7 has a different structure, but the supporting portion 130 has a hollow lumen structure that is not hollowed out no matter what the structure of the flexible portion 120 is. And, the bending property of the flexible portion 120 is higher than that of the supporting portion 130.
In an embodiment, the material of the supporting portion 130 is a polymer material, such as PE, pebax, PP, or the like. The support 130 should have a certain bending property while having good supporting and pushing properties to be able to smoothly push the adjustable bending system 100 along the guide wire path to a predetermined position.
In an embodiment, the axial length L2 of the supporting portion 130 is 75% -90% of the total axial length L of the puncture sheath 10, so as to ensure that the puncture sheath 10 has sufficient pushing performance while satisfying the bending performance of the puncture sheath 10.
In one embodiment, the axial length L2 of the support 130 is 80% of the total axial length L of the puncture sheath 10.
In an embodiment, the flexible portion 120 is a non-hollowed-out lumen structure, and the flexible portion 120 is a lumen structure with smooth inner and outer surfaces, the material of the flexible portion 120 is the same as that of the supporting portion 130, and the wall thickness of the flexible portion 120 is smaller than that of the supporting portion 130, so that the flexibility of the flexible portion 120 is greater than that of the supporting portion 130, and thus the flexible portion 120 has a bending property higher than that of the supporting portion 130.
In an embodiment, the flexible portion 120 is a non-hollowed-out lumen structure, and the flexible portion 120 is a lumen structure with smooth inner and outer surfaces, the flexible portion 120 is made of the same or different material as the support portion 130, and the wall thickness of the flexible portion 120 is equal to the wall thickness of the support portion 130. But the hardness of the flexible portion 120 is smaller than that of the supporting portion 130, i.e., the flexibility of the flexible portion 120 is greater than that of the supporting portion 130, so that the bending property of the flexible portion 120 is higher than that of the supporting portion 130.
For example, in one embodiment, the flexible portion 120 is a non-hollow lumen structure made of a polymer material with a hardness of 63D, 55D, 40D or 35D, and the supporting portion 130 is a non-hollow lumen structure made of a polymer material with a hardness of more than 63D.
In one embodiment, the flexible portion 120 is made of Pebax material with a durometer of 55D. The support 130 is made of Pebax material with a hardness of 72D.
In one embodiment, the flexible portion 120 includes a matrix material and a conditioning material doped into the matrix material. The base material is a polymer material, and the adjusting material is used for adjusting the flexibility and bending performance of the flexible portion 120. The regulating material is an elastic material.
The base material of the flexible portion 120 may be the same as or different from the material of the support portion 130, and the flexibility of the flexible portion 120 may be made greater than the flexibility of the support portion 130 by adding a regulating material.
In an embodiment, the material of the supporting portion 130 is a PE material. The base material of the flexible portion 120 is a PE material, and the conditioning material is an ethylene-vinyl acetate copolymer (EVA) material or a rubber material. The ratio of the base material and the adjustment material is not particularly limited as long as it is satisfied that the flexible portion 120 has a certain bending property and pushing property, and the bending property of the flexible portion 120 is higher than that of the supporting portion 130.
In an embodiment, the mass ratio of the matrix material and the adjusting material of the flexible portion 120 is 5% -30%, and the bending performance of the flexible portion 120 is better than the supporting performance of the supporting portion 130, and the hardness ratio of the flexible portion 120 to the supporting portion 130 is 1:1.2-1:2, so as to give consideration to both the pushing performance and the bending performance of the puncture sheath 10, improve the smoothness of the operation, and be beneficial to improving the success rate of the operation.
Referring back to fig. 2, in an embodiment, the puncture sheath 10 further includes a first transition portion 140, where the first transition portion 140 is located between the puncture portion 110 and the flexible portion 120, and two ends of the first transition portion 140 are connected to the puncture portion 110 and the flexible portion 120, respectively.
In one embodiment, the first transition 140 is a hollow cylindrical structure. The transition part 140 can be positioned well, and pushing is convenient.
In an embodiment, the axial length L3 of the first transition portion 140 is 2% -5% of the total axial length L of the puncture sheath 10, so as to achieve better positioning and ensure better bending performance of the distal end of the puncture sheath 10.
Referring to fig. 8, in one embodiment, the puncture sheath 10 further includes a second transition portion 150, and the second transition portion 150 is a hollow cylindrical sleeve. A second transition portion 150 is provided to facilitate coupling the flexible portion 120 and the support tube 130. The second transition portion 150 has one end connected to the ring 122 of the flexible portion 120 and the other end connected to the support tube 130. The second transition portion 150 may be formed integrally with the proximal-most annular member 122 of the flexible portion 120, such as by injection molding.
In an embodiment, the hardness of the puncture part 110 is smaller than the hardness of the flexible part 120 and the supporting part 130, and the puncture part 110 first enters the bending part when passing through the curved lumen path, so that the puncture part 110 has a better flexibility, and the puncture part 110 can enter the bending part conveniently. In addition, the end of the puncture part 110 away from the flexible part 120 has a tip structure, and even if the hardness of the puncture part 110 is small, the puncture part 110 can enter the curved lumen structure along the guide wire, and a good guiding effect can be achieved.
In an embodiment, the ratio of the axial lengths of the puncture part 110, the flexible part 120 and the supporting part 130 is 1:10:80, and the ratio of the hardness of the puncture part 110, the flexible part 120 and the supporting part 130 is 1:1 (1.5-2), so that the flexibility and the puncture performance of the puncture sheath 10 are better, and the operation is convenient.
In one embodiment, the piercing portion 110 has a hollow tapered structure with openings at both ends, and the inner cavity of the piercing portion 110 has a cylindrical shape, so that the piercing portion 110 has a sufficient wall thickness to facilitate piercing and guiding.
Referring to fig. 9, the adjustable curved sheath assembly 20 includes an adjustable curved sheath 210 and a control portion 220 connected to the adjustable curved sheath 210, wherein the adjustable curved sheath 210 can be changed between a straightened state and a curved state, and the control portion 220 is used for controlling the adjustable curved sheath 210 to be in a straightened state or a curved state.
The adjustable curved sheath 210 is a hollow tubular structure with two open ends, and includes a sidewall, the sidewall encloses an inner cavity with two open ends, and at least part of the puncture sheath 10 is movably accommodated in the inner cavity of the adjustable curved sheath 210, as shown in fig. 1.
Referring back to fig. 9, the adjustable sheath 210 includes a straight tube portion 212 and an adjustable bend portion 214 axially connected to a distal end of the straight tube portion 212, and the control portion 220 is normally operated to bend the adjustable bend portion 214 with respect to the straight tube portion 212 or return the adjustable bend portion 214 and the straight tube portion 212 from a bent state to a state in which they are in the same straight line.
The control mechanism of the control section 220 is any means known to those skilled in the art. In one embodiment, the control portion 220 includes a control wire (not shown) partially embedded in the side wall of the sheath tube 210 and a control handle 224, and the other portion is accommodated in the control handle 224, and the control wire is pulled by the control handle 224 to bend the adjustable bend 214 of the adjustable bend sheath tube 210 relative to the straight tube 212.
In one embodiment, the adjustable bend sheath assembly 20 further includes a valve seat 240, the valve seat 240 being connected to an end of the straight tube portion 212 remote from the adjustable bend portion 214, the control portion 220 being indirectly connected to the straight tube portion 212 through the valve seat 240. The control unit 220, the valve seat 240 and the adjustable curved sheath 210 are substantially Y-shaped, wherein the control unit 220 and the valve seat 240 are two inclined branches of the Y-shape, and the adjustable curved sheath 210 is a straight rod in the middle of the Y-shape.
The valve seat 240 has a structure with two open ends and an inner cavity of the valve seat 240 is communicated with the inner cavity of the adjustable bending sheath 210. In one embodiment, the valve seat 240 is further provided with an additional channel assembly 260 in communication with the lumen of the adjustable bend sheath 210, and the additional channel assembly 260 may be used for venting, delivering medical fluids, delivering contrast fluids, etc., as desired. The control part 220, the valve seat 240 and the adjustable bend sheath 210 are approximately Y-shaped, so as to facilitate bending adjustment operation and operation of exhausting or delivering liquid medicine, contrast liquid and the like.
In use of the adjustable bending system 100, the adjustable bending sheath 210 is first placed in a straightened state, and then the puncture sheath 10 is extended from the valve seat 240 into the adjustable bending sheath 210, and the puncture sheath 10 is advanced distally such that the puncture portion 110 of the puncture sheath 10 extends outside of the adjustable bending sheath 210. Further, the flexible portion 120 of the puncture sheath 10 is radially opposed to the bendable portion 214 of the bendable sheath 210, as shown in fig. 10.
Returning to fig. 2, in one embodiment, the puncture sheath 10 further comprises a connector 160, the connector 160 being connected to the proximal end of the support tube 130. The adapter 160 is hollow and has an inner lumen, and the inner lumen of the adapter 160 communicates with the inner lumen of the rest of the puncture sheath 10 to facilitate entry along a guidewire into a body lumen for delivery of medical devices, medications, etc. into the body. The outer diameter of the fitting 160 is greater than the outer diameter of the adjustable bend sheath 210.
By properly setting the axial length of the introducer sheath 10 and matching the axial length of the flexible portion 120 with the axial length of the adjustable bend 214, the introducer sheath 110 is positioned outside of the adjustable bend 210 with the flexible portion 120 radially opposite the adjustable bend 214 when the introducer sheath 10 is extended proximally into the adjustable bend 210 and displaced distally axially into abutment of the hub 160 with the proximal end of the adjustable bend 210 (as shown in fig. 10).
It should be noted that, when the puncture sheath 10 further includes the adapter 160, the total axial length L of the puncture sheath 10 described above does not include the axial length of the adapter 160.
In an embodiment, the axial length of the flexible portion 120 is greater than or equal to the axial length of the adjustable bending portion 214, so that the flexible portion 120 of the adjustable bending system 100 has better bending performance, and is easy to bend and pass through the curved body cavity path.
In an embodiment, the inner diameter of the adjustable bending portion 214 is equal to the inner diameter of the straight tube portion 212, and the wall thickness of the adjustable bending portion 214 is smaller than the wall thickness of the straight tube portion 212, so that the flexibility of the adjustable bending portion 214 is better, and when the puncture sheath 10 stretches into the adjustable bending sheath 210, the flexibility of the whole portion of the flexible portion 120 opposite to the adjustable bending portion 214 is better, and the bending is easy.
In one embodiment, the fitting 160 is a luer fitting to facilitate removable connection with other components.
The puncture sheath 10 of the bending-adjustable system 100 is provided with the flexible portion 120 with higher bending performance than the supporting portion 130 between the puncture portion 110 and the supporting portion 130, so that the puncture sheath 10 has better bending performance and can be well adapted to the bending form of the lumen. Therefore, when the bending system 100 is used to enter a curved body cavity, the bending performance of the flexible portion 120 is better, and the puncture sheath 10 does not need to be withdrawn before the bending operation is performed on the bending sheath tube 210, so that the bending can be directly performed, as shown in fig. 10. The puncture sheath 10 with special structural design facilitates the operation of the bending-adjustable system 100, and is beneficial to improving the operation efficiency.
As shown in fig. 11, the adjustable bending system 100 is used to access a branch vessel 201 of the abdominal aorta 200. Firstly, the guide wire 300 is introduced into the branch vessel 201 from outside the body, after the adjustable bending system 100 is assembled, the adjustable bending system 200 is introduced into the abdominal aorta 200 along the guide wire 300, and when the branch vessel 201 is approached, the puncture sheath 10 is not required to be withdrawn, but the adjustable bending operation is directly performed, so that the adjustable bending system 200 can be bent to enter the branch vessel 201 along the guide wire 300, and the operation is convenient.
When it is desired to deliver a substance such as a medical fluid, contrast media, etc. after the adjustable bend system 200 has been introduced into the branch vessel 201, the substance may be delivered from the connector 160 or the opening of the additional channel assembly 260, or simultaneously from the connector 160 and the additional channel assembly 250, to improve efficiency and reduce the procedure time.
After the adjustable bending system 200 is introduced into the branch vessel 201, when an implantable device, such as a branch stent, is required to be delivered, the puncture sheath 10 is withdrawn, and the branch stent is directly introduced into the branch vessel 201 along the adjustable bending sheath 210.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (9)
1. The puncture sheath is characterized by comprising a puncture part, a flexible part and a supporting part, wherein two ends of the flexible part are respectively connected with the puncture part and the supporting part, and the bending performance of the flexible part is higher than that of the supporting part;
the flexible part comprises a plurality of annular parts which are arranged at intervals along the axial direction;
the flexible part further comprises a reinforcing part, adjacent annular parts are connected through an axial connecting part, a hollowed part is arranged between the adjacent annular parts, and the hollowed part is filled with the reinforcing part, so that the flexible part is of a non-hollowed pipe cavity structure;
The distance from the outer peripheral surface of the reinforcing member to the central axis of the annular member is smaller than the radius of the annular member.
2. The puncture sheath of claim 1, wherein the axial length of the support is 75-90% of the total axial length of the puncture sheath.
3. The puncture sheath according to claim 1, wherein adjacent ring members are connected by an axial connector, and hollow portions are provided between the adjacent ring members.
4. The puncture sheath of claim 1, wherein the flexible portion and the support portion are each a non-hollowed-out lumen structure, and the flexible portion has a flexibility greater than the support portion.
5. The puncture sheath of claim 4, wherein the flexible portion and the support portion are of the same material and the wall thickness of the flexible portion is less than the wall thickness of the support portion such that the flexibility of the flexible portion is greater than the flexibility of the support portion;
Or the hardness of the flexible portion is smaller than that of the supporting portion, so that the flexibility of the flexible portion is greater than that of the supporting portion.
6. The puncture sheath according to claim 4, wherein the flexible portion comprises a base material and a regulating material doped in the base material, the base material being the same as or different from the material of the supporting portion, the regulating material being for enhancing flexibility of the flexible portion so that the flexible portion is greater than the flexibility of the supporting portion.
7. The puncture sheath of claim 1, further comprising a transition portion between the puncture portion and the flexible portion, wherein one end of the transition portion is connected to the puncture portion and the other end is connected to the flexible portion.
8. A buckling system comprising a buckling assembly and the puncture sheath of any of claims 1-7, the buckling assembly comprising a buckling sheath tube, at least a portion of the puncture sheath being movably received in the buckling sheath tube.
9. The adjustable bend system of claim 8 wherein the adjustable bend sheath includes an adjustable bend, the flexible portion having an axial length that is not less than an axial length of the adjustable bend such that the adjustable bend opposes the flexible portion when at least a portion of the puncture sheath is received in the adjustable bend sheath.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011334680.2A CN114533208B (en) | 2020-11-24 | 2020-11-24 | Puncture sheath and bending-adjustable system |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011334680.2A CN114533208B (en) | 2020-11-24 | 2020-11-24 | Puncture sheath and bending-adjustable system |
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| CN114533208A CN114533208A (en) | 2022-05-27 |
| CN114533208B true CN114533208B (en) | 2024-07-16 |
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| CN202011334680.2A Active CN114533208B (en) | 2020-11-24 | 2020-11-24 | Puncture sheath and bending-adjustable system |
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| JP2000126301A (en) * | 1998-10-27 | 2000-05-09 | Terumo Corp | Medical tube |
| CN209695326U (en) * | 2018-12-28 | 2019-11-29 | 徐州市妇幼保健院 | A kind of flexible puncture outfit of laparoscopic surgery |
| CN111248947A (en) * | 2018-11-30 | 2020-06-09 | 杭州堃博生物科技有限公司 | Bendable Biopsy Needle and Biopsy System |
| CN111902183A (en) * | 2018-02-22 | 2020-11-06 | 血管科学有限公司 | Microfabricated catheter with intermediate preferential bend section |
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| FR2703428B1 (en) * | 1993-03-29 | 1995-07-07 | Hutchinson | Fluid line based on plastic material (s). |
| US8876772B2 (en) * | 2005-11-16 | 2014-11-04 | Boston Scientific Scimed, Inc. | Variable stiffness shaft |
| CN108261256B (en) * | 2016-12-31 | 2024-05-07 | 深圳市健心医疗科技有限公司 | Conveying device and conveying system |
| US11931522B2 (en) * | 2019-05-09 | 2024-03-19 | Neuravi Limited | Inflation lumen kink protection and balloon profile |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2000126301A (en) * | 1998-10-27 | 2000-05-09 | Terumo Corp | Medical tube |
| CN111902183A (en) * | 2018-02-22 | 2020-11-06 | 血管科学有限公司 | Microfabricated catheter with intermediate preferential bend section |
| CN111248947A (en) * | 2018-11-30 | 2020-06-09 | 杭州堃博生物科技有限公司 | Bendable Biopsy Needle and Biopsy System |
| CN209695326U (en) * | 2018-12-28 | 2019-11-29 | 徐州市妇幼保健院 | A kind of flexible puncture outfit of laparoscopic surgery |
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| CN114533208A (en) | 2022-05-27 |
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