CN116196054A

CN116196054A - Hemostatic assembly, hemostatic valve and catheter sheath

Info

Publication number: CN116196054A
Application number: CN202111455287.3A
Authority: CN
Inventors: 郭于林; 张金龙; 陈国明
Original assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Current assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Priority date: 2021-12-01
Filing date: 2021-12-01
Publication date: 2023-06-02

Abstract

The invention relates to a hemostatic assembly, a hemostatic valve and a catheter sheath, wherein the hemostatic assembly comprises a hemostatic valve, a sheath seat and a sheath cap arranged on the sheath seat; the hemostatic valve comprises an elastic plate body, and the peripheral part of the elastic plate body is compactly arranged between the sheath seat and the sheath cap; under the compression of the sheath seat and the sheath cap to the peripheral part, a concave surface is formed at the middle part. The peripheral part of the elastic plate body is fixed between the sheath seat and the sheath cap, and the peripheral part of the elastic plate body is extruded by the sheath cap, so that the middle part of the elastic plate body automatically protrudes towards the distal end of the catheter sheath, and the proximal end forms a concave surface. The concave surface is convenient for guiding the instrument to pass through the combination gap and enter the sheath tube, and the axial force generated by assembly extrusion counteracts the friction force generated by the instrument and the elastic plate body when the instrument is withdrawn, so as to achieve the effect of preventing eversion. In addition, the concavity enhances the hemostatic and hemostatic stability of the catheter sheath. In addition, material is saved.

Description

Hemostatic assembly, hemostatic valve and catheter sheath

Technical Field

The invention relates to the technical field of medical instruments, in particular to a hemostatic assembly, a hemostatic valve and a catheter sheath.

Background

With the development of interventional therapy for cardiovascular diseases and other body organ diseases, the catheter interventional therapy is widely applied to various diseases. The transcatheter interventional therapy is a common therapeutic way of introducing a specific instrument into a lesion site of a human body through a catheter by a natural cavity or a tiny wound of the human body. The treatment is suitable for various tracheal diseases and vascular diseases including the whole body, and has the advantages of small wound, quick recovery and easy acceptance of patients, such as transcatheter aortic valve replacement (Transcatheter Aortic Valve Replacement, TAVR).

One implementation of Transcatheter Aortic Valve Replacement (TAVR) is through femoral artery intervention, delivery of a prosthetic heart valve to the diseased aortic valve site by a delivery system, replacement of the diseased heart valve with the prosthetic heart valve, and restoration of valve function. The transcatheter aortic valve replacement has the advantages of micro-trauma, quick recovery, and avoidance of extracorporeal circulation and blood transfusion during operation, and has a rapid growing trend. The aortic valve replacement needs to use a catheter sheath to pre-establish a vascular access, on one hand, the vascular access of a human body is established, so that instruments (such as a dilator, a conveying device, a guide wire and the like) can conveniently enter and exit the human body, and on the other hand, the aortic valve replacement plays a role in stopping bleeding and prevents the blood loss of a patient during operation. The vascular access established by the catheter sheath not only needs to meet the requirement of the entrance of the instrument, but also can ensure the smooth withdrawal of the instrument.

The size of the catheter sheath is selected according to the size of the blood vessel of the patient, and when the prosthesis is implanted in the blood vessel and the instrument needs to be withdrawn from the catheter sheath, high pressure is usually formed between the catheter sheath and the head end (especially the delivery device) of the instrument, so that the catheter sheath sprays blood, which can cause blood loss of the patient, even affect the operation of a doctor, and increase the risk of the operation process.

Disclosure of Invention

Based on this, it is necessary to overcome the drawbacks of the prior art and to provide a hemostatic assembly, hemostatic valve and catheter sheath that are better able to prevent blood ejection.

The technical scheme is as follows: a hemostatic assembly comprising a hemostatic valve, a sheath hub and a sheath cap disposed on the sheath hub; the hemostatic valve comprises an elastic plate body, and the peripheral part of the elastic plate body is compactly arranged between the sheath seat and the sheath cap; under the compression of the sheath seat and the sheath cap to the peripheral part, a concave surface is formed at the middle part.

In one embodiment, the elastic plate body is provided with a first surface and a second surface which are opposite, the first surface is provided with at least one first slit, the first slit does not extend to the second surface in a penetrating way, the second surface is provided with at least one second slit, the second slit does not extend to the first surface in a penetrating way, the first slit and the second slit are arranged in a crossing way, and a combination slit at the crossing position of the first slit and the second slit penetrates from the first surface to the second surface.

In one embodiment, the elastic plate body has a thickness D, and the first slit has a depth S ₁ The depth of the second kerf is S ₂ ，S ₁ <D,S ₂ <D,S ₁ +S ₂ ≥D。

In one embodiment, wherein the depth S ₁ Depth S ₂ The following relationships are satisfied with the thickness D: 0.3D<S ₁ <0.9D,0.3D<S ₂ <0.9D。

In one embodiment, the elastic plate body is a plate with uniform thickness; or the thickness of the middle part of the elastic plate body is larger than that of the peripheral part of the elastic plate body.

In one embodiment, the first slit is a straight slit, a zigzag slit, an S-shaped slit, a W-shaped slit or a circular arc slit; the second kerf is a straight kerf, a Z-shaped kerf, an S-shaped kerf, a W-shaped kerf or an arc kerf.

In one embodiment, the first slit is one and the second slit is one.

In one embodiment, the elastic plate body is a silica gel plate or a rubber plate.

In one embodiment, a lubricious coating is provided on the first surface and/or the intermediate portion of the second surface.

In one embodiment, the point where the central axis of the sheath seat intersects with the concave surface is an intersection point, the intersection point is connected with any point on the top edge of the inner wall of the sheath seat to form a connecting line, the connecting line and the central axis of the sheath seat form an included angle, the included angle between the connecting line and the central axis of the sheath seat is a, and the included angle a is 15-75 degrees.

In one embodiment, the hemostatic valve is clamped in an assembly gap formed by the sheath cap and the sheath seat; in the region where the hemostatic valve, the sheath cap and the sheath seat overlap each other in the axial direction of the sheath seat, the minimum value of the assembly gap is H; the thickness of the position on the hemostatic valve, which is in contact with the assembly clearance with the minimum value H, before assembly is d, and H < d.

In one embodiment, the sheath seat is provided with at least one first step at a position contacted with the elastic plate body, and the sheath cap is provided with at least one second step at a position contacted with the elastic plate body.

In one embodiment, the first surface is in contact with the sheath cap and the second surface is in contact with the sheath hub; the area of the sheath cap, which is contacted with the first surface, is larger than the area of the sheath seat, which is contacted with the second surface.

In one embodiment, the sheath cap is in clamping fit with the sheath seat, is fixed in an adhesive manner or is fixed in a connecting manner by a fastener.

In one embodiment, the sheath cap comprises a cap body sleeved at one end of the sheath seat and a collision plate connected with one end of the cap body; the interference plate is provided with a through hole for passing an instrument, and the peripheral part of the elastic plate body is closely and fixedly abutted against the end surface of the sheath seat; one of the cap body and the sheath seat is provided with a buckle, and the other is provided with a clamping hole matched with the buckle.

In one embodiment, the outer wall surface of the end portion of the sheath seat for mounting the cap body is a conical surface with an outer diameter gradually decreasing in a direction toward the abutting plate.

In one embodiment, the sheath seat is provided with a through hole, and the wall of the through hole is provided with a supporting part in a surrounding manner; the sheath cap comprises a cap body arranged in the through hole and a collision plate connected with one end of the cap body, wherein the collision plate is provided with a through hole for an instrument to pass through and is tightly and fixedly connected with the periphery of the elastic plate body on the supporting part in a collision manner; one of the cap body and the sheath seat is provided with a buckle, and the other is provided with a clamping hole matched with the buckle.

In one embodiment, the hemostatic assembly further comprises a guide valve, the guide valve is arranged in the sheath seat, a central hole and a third cutting joint communicated with the central hole are arranged in the middle of the guide valve, and the central hole and the third cutting joint penetrate through two opposite surfaces of the guide valve.

In one embodiment, the surface of the guide valve facing the elastic plate body is a third surface, and the third surface is a spherical surface or a conical surface concaved towards a direction far away from the elastic plate body.

In one embodiment, the surface of the guide valve facing away from the elastic plate body is a fourth surface, and the fourth surface is a spherical surface concavely arranged towards a direction close to the elastic plate body.

In one embodiment, the central hole has a depth L.ltoreq.4 mm.

In one embodiment, the outer wall of the guide valve is circumferentially provided with a groove, and the hemostatic assembly further comprises a fixing ring matched with the groove, and the fixing ring is sleeved in the groove.

In one embodiment, the hemostatic assembly further comprises a protective shell detachably connected to the sheath mount; one end of the protective shell is inserted into the sheath seat, and the other end of the protective shell is positioned outside the sheath seat; the outer wall of the protective housing is provided with a third step, and the third step is in contact with one end of the sheath seat.

In one embodiment, a first thread is arranged on the outer wall of the protective casing, a second thread corresponding to the first thread is arranged on the hole wall of the through hole, and the protective casing is detachably arranged on the sheath seat through the first thread and the second thread.

A hemostatic valve, the hemostatic valve comprising: the elastic plate body is provided with a first surface and a second surface which are opposite, the first surface is provided with at least one first slit, the first slit does not extend to the second surface in a penetrating way, the second surface is provided with at least one second slit, the second slit does not extend to the first surface in a penetrating way, the first slit and the second slit are arranged in a crossing way, a combined slit at the crossing position of the first slit and the second slit penetrates to the second surface from the first surface, and under the compression of the peripheral part of the elastic plate body, a concave surface can be formed at the middle part of the elastic plate body.

A catheter sheath comprising the hemostatic assembly, the catheter sheath further comprising a sheath tube, the sheath tube being connected to the sheath hub.

According to the hemostatic assembly, the peripheral part of the elastic plate body is fixed between the sheath seat and the sheath cap, the peripheral part of the elastic plate body is extruded by the sheath cap, the middle part of the elastic plate body automatically protrudes towards the distal end of the catheter sheath, and the proximal end forms a concave surface. The concave surface is convenient for guiding the instrument to pass through the combination gap and enter the sheath tube, and the axial force generated by assembly extrusion counteracts the friction force generated by the instrument and the elastic plate body when the instrument is withdrawn, so as to achieve the effect of preventing eversion. In addition, the concavity enhances the hemostatic and hemostatic stability of the catheter sheath. In addition, material is saved.

When the hemostatic valve is arranged on the catheter sheath, the peripheral part of the elastic plate body is fixed between the sheath seat and the sheath cap, the peripheral part of the elastic plate body is extruded by the sheath cap, and the middle part of the elastic plate body protrudes towards the far end of the catheter sheath and the near end forms a concave surface. The concave surface is convenient for guiding the instrument to pass through the combination gap and enter the sheath tube, and the axial force generated by assembly extrusion counteracts the friction force generated by the instrument and the elastic plate body when the instrument is withdrawn, so as to achieve the effect of preventing eversion. In addition, the concavity enhances the hemostatic and hemostatic stability of the catheter sheath. In addition, material is saved.

According to the catheter sheath, the peripheral part of the elastic plate body is fixed between the sheath seat and the sheath cap, the peripheral part of the elastic plate body is extruded by the sheath cap, so that the middle part of the elastic plate body protrudes towards the distal end of the catheter sheath, and the proximal end forms a concave surface. The concave surface is convenient for guiding the instrument to pass through the combination gap and enter the sheath tube, and the axial force generated by assembly extrusion counteracts the friction force generated by the instrument and the elastic plate body when the instrument is withdrawn, so as to achieve the effect of preventing eversion. In addition, the concavity enhances the hemostatic and hemostatic stability of the catheter sheath. In addition, material is saved.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention.

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view of a catheter sheath and an instrument according to an embodiment of the present invention;

fig. 2 is an exploded view of a hemostatic assembly according to an embodiment of the present invention;

FIG. 3 is a cross-sectional view of the assembled FIG. 2;

FIG. 4 is an enlarged partial block diagram of FIG. 3;

fig. 5 is an exploded view of a hemostatic assembly according to another embodiment of the present invention;

FIG. 6 is a cross-sectional view of the assembled FIG. 5;

fig. 7 is an exploded view of a hemostatic assembly according to yet another embodiment of the present invention;

FIG. 8 is a cross-sectional view of the assembled FIG. 7;

FIG. 9 is a schematic view of a pilot valve according to an embodiment of the present invention;

FIG. 10 is a schematic cross-sectional view of the pilot valve of FIG. 9;

FIG. 11 is a schematic view of a pilot valve according to another embodiment of the present invention;

fig. 12 is a schematic cross-sectional structure of the pilot valve shown in fig. 11.

10. A catheter sheath; 11. a hemostatic assembly; 111. a hemostatic valve; 1111. a first surface; 1112. a second surface; 11121. a second slit; 1113. peripheral parts; 1114. a concave surface; 1115. connecting wires; 112. a sheath seat; 1121. a connection end; 1122. a first step; 1123. a clamping hole; 1124. conical surfaces; 1125. a through hole; 1126. a support part; 1127. a second thread; 113. a sheath cap; 1131. a second step; 1132. a cap body; 1133. a contact plate; 11331. a via hole; 1134. a buckle; 114. a communication valve; 115. a pilot valve; 1151. a central bore; 1152. a third slit; 1153. a third surface; 1154. a fourth surface; 11541. a guide block; 1155. a groove; 1158. a first buffer; 1159. reinforcing ribs; 116. a fixing ring; 117. a protective shell; 1171. a third step; 1172. a semi-open space; 1173. a first thread; 12. a sheath.

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 present 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 of the invention, whereby the invention is not limited to the specific embodiments disclosed below.

Referring to fig. 1, fig. 1 shows a schematic view of a catheter sheath 10 and an apparatus according to an embodiment of the present invention, in one embodiment, a catheter sheath 10, the catheter sheath 10 including a hemostatic assembly 11, the catheter sheath 10 further including a sheath tube 12, the sheath tube 12 being connected to a sheath hub 112.

Referring to fig. 2 to 4, fig. 2 is an exploded view of the hemostatic assembly 11 according to an embodiment of the present invention, fig. 3 is a sectional view of fig. 2 assembled together, and fig. 4 is a partially enlarged structural view of fig. 3. In one embodiment, the hemostatic assembly 11 includes a hemostatic valve 111, a sheath hub 112 and a sheath cap 113 disposed on the sheath hub 112. The peripheral portion 1113 of the elastic plate body of the hemostatic valve 111 is compressively disposed between the sheath holder 112 and the sheath cap 113. Under the compression of the sheath holder 112 and the sheath cap 113 to the outer peripheral portion 1113 of the elastic plate body, the middle portion of the elastic plate body protrudes toward the distal end of the catheter sheath 10, and a concave surface 1114 is formed at the middle portion of the elastic plate body.

The distal end of the catheter sheath 10 refers to the end of the catheter sheath 10 that enters the interior of the human body, and the proximal end of the catheter sheath 10 refers to the other end of the catheter sheath 10. Concave 1114 refers to the proximal face of the elastic plate body under compression of the sheath seat and the sheath cap to the peripheral portion of the elastic plate body; specifically, under the compression of the sheath seat and the sheath cap to the peripheral part of the elastic plate body, the proximal end surface of the elastic plate body faces to the concave surface formed by the inward concave of the distal direction of the catheter sheath.

The peripheral portion 1113 of the elastic plate body refers to a portion of the elastic plate body opposite to a plate body portion far from a central area of a plate surface of the elastic plate body, specifically, for example, a peripheral edge portion of the elastic plate body; the middle part of the elastic plate body refers to a plate body part of the elastic plate body, which surrounds the central area of the central axis in the elastic plate body, and the peripheral part 1113 of the elastic plate body is arranged around the middle part of the elastic plate body.

Referring to fig. 2 to 4, specifically, the hemostasis valve 111 includes an elastic plate body. The elastic plate body is provided with a first surface 1111 and a second surface 1112 which are opposite to each other. The first surface 1111 is provided with at least one first slit (not shown) which does not extend through to the second surface 1112. The second surface 1112 is provided with at least one second slit 11121. The second slit 11121 does not extend through to the first surface 1111, the first slit and the second slit 11121 are disposed to intersect, the intersection position of the first slit and the second slit 11121 is located at the middle portion of the elastic plate body, and the combination slit (not shown) of the intersection position of the first slit and the second slit 11121 extends through from the first surface 1111 to the second surface 1112. The central portion of the elastic plate body can be formed with a concave surface 1114 under the compression fixation of the peripheral portion of the elastic plate body.

It should be noted that the first slit includes, but is not limited to, being formed by cutting through a cutting member (e.g., a blade) on the first surface 1111, and the second slit 11121 includes, but is not limited to, being formed by cutting through a cutting member on the second surface 1112.

It should be noted that the fact that the first slit does not extend through to the second surface 1112 means that, in a state where the elastic plate body is not assembled with the sheath base 112 and/or the sheath cap 113, the depth of the first slit is smaller than the thickness D of the elastic plate body, so that the first slit does not extend through the elastic plate body. Likewise, the second slit 11121 not extending through to the first surface 1111 means that in a state where the elastic plate body is not assembled with the sheath base 112 and/or the sheath cap 113, the depth of the second slit 11121 is smaller than the thickness of the elastic plate body, so that the second slit 11121 does not extend through the elastic plate body.

In addition, when the first slit and the second slit 11121 are disposed to intersect each other, the combination slit is a slit at the intersection position. When the combination slit extends through the first surface 1111 and the second surface 1112, an instrument (e.g., a dilator) is aligned with the combination slit and can be passed through the elastic plate into the sheath 12 by an external force.

When the hemostatic valve 111 is mounted on the catheter sheath 10, the peripheral portion 1113 of the elastic plate body is fixed between the sheath holder 112 and the sheath cap 113, and the peripheral portion 1113 of the elastic plate body is extruded by the sheath holder 112 and the sheath cap 113, so that the middle portion of the elastic plate body protrudes toward the distal end of the catheter sheath 10, and the proximal end forms the concave surface 1114. The concave surface 1114 facilitates guiding the instrument through the combination slit into the sheath 12, and the axial force generated by the assembly extrusion counteracts the friction force generated by the elastic plate body when the instrument is withdrawn, thereby achieving the effect of preventing eversion. In addition, concave surface 1114 enhances the hemostatic and hemostatic stability of catheter sheath 10. In addition, material is saved.

Referring to FIG. 4, in one embodiment, the elastic plate body has a thickness D and the first slit has a depth S ₁ The depth of the second slit 11121 is S ₂ ，S ₁ <D,S ₂ <D,S ₁ +S ₂ And D is not less than. Thus, the combination slit at the intersection of the first slit and the second slit 11121 penetrates the first surface 1111 and the second surface 1112.

Referring to FIG. 4, in one embodiment, wherein the depth S ₁ Depth S ₂ The following relationships are satisfied with the thickness D: 0.3D<S ₁ <0.9D,0.3D<S ₂ <0.9D. More specifically, depth S ₁ Depth S ₂ The same and are each, for example, 2/3D or 3/4D. Therefore, the instrument can be ensured to pass through the combination seam smoothly, and meanwhile, the elastic plate body cannot be damaged in the process of passing through the instrument.

In one embodiment, the elastic plate body is a plate with uniform thickness; alternatively, the thickness of the middle part of the elastic plate body is larger than that of the outer part 1113 of the elastic plate body; alternatively, the elastic plate body may be a plate member having an irregular thickness, which is not limited herein. When the thickness of the middle part of the elastic plate body is greater than that of the peripheral part 1113 of the elastic plate body, the depth of the combined seam is deep enough, and after the instrument penetrates into the sheath tube 12 of the catheter sheath 10 through the combined seam, the joint area of the joint wall of the combined seam, which is tightly attached to the outer wall of the instrument, is large, so that a good hemostatic effect can be ensured. Of course, the thickness D of the elastic plate body is controlled within a preset range, so that the problem that the friction force between the instrument and the seam wall of the combination seam is large and the instrument cannot conveniently and smoothly pass through the combination seam due to the fact that the thickness D is too large is avoided.

Referring to FIG. 4, in one embodiment, the first slit is a straight slit, a Z-shaped slit, an S-shaped slit, a W-shaped slit, or a circular arc slit; the second slit 11121 is a straight slit, a zigzag slit, an S-shaped slit, a W-shaped slit, or a circular arc slit. The first slit and the second slit 11121 are not limited to the slit having the above-described shape, but may be, for example, a linear slit, a zigzag slit, or a curved slit, and may be provided according to actual needs, i.e., the slit shape is not limited thereto.

In one embodiment, there are at least two first slits and at least two second slits 11121. The intersection of all the first slits with all the second slits 11121 is at the same location of the elastic panel body. Specifically, the crossing positions of all the first slits and all the second slits 11121 are located at the very center position of the elastic plate body, or at the region (region within 2mm radius with the center position as the center) on the elastic plate body where the distance from the very center position is kept within 2 mm. In addition, specifically, the projections of the at least two first slits and the at least two second slits 11121 on the first surface 1111 can uniformly divide the first surface 1111 into a plurality of portions, and the projections of the two first slits and the two second slits 11121 on the first surface 1111 are in a shape of a Chinese character 'mi' by taking the first slits as two and the second slits 11121 as two examples. Therefore, in the process that the instrument passes through the combination seam, the combination seam part of the elastic plate body is evenly split outwards, so that the instrument can smoothly pass through the combination seam, and meanwhile, the damage to the elastic plate body in the process that the instrument passes through the combination seam can be avoided.

In one embodiment, the first slit and the second slit 11121 are both in-line slits, and the angle between the first slit and the second slit 11121 is, for example, 45 ° to 90 °, but may be other angles, which are not limited herein, and are set according to practical situations.

In one embodiment, the elastic plate body is a circular plate, an elliptical plate or a polygonal plate. The elastic plate body may be a plate body of other shapes, and is not limited herein, and may be set according to actual needs.

Alternatively, the elastic plate body includes, but is not limited to, a silicone plate and a rubber plate. The elastic plate body can also be made of other materials, is not limited herein, and can be arranged according to actual requirements.

In one embodiment, a lubricious coating (not shown) is provided on the first surface 1111 and/or the second surface 1112 at a mid-point thereof. Thus, the smooth coating can reduce friction force generated in the process of contacting the elastic plate body with the instrument, can facilitate the insertion of the instrument into the catheter sheath 10, and also facilitates the outward extraction of the instrument out of the catheter sheath 10. In particular, the lubricious coating is, for example, a biocompatible lubricating medium or other lubricious material. In addition, when a smooth coating is provided only at the middle portion on the first surface 1111 or the second surface 1112, in order to ensure contact with the smooth coating when the instrument is mounted inside the catheter sheath 10, it is necessary to make the surface of the elastic plate body on which the smooth coating is provided away from the sheath tube 12 during the assembly of the hemostatic valve 111 between the sheath hub 112 and the sheath cap 113 of the catheter sheath 10. When the first surface 1111 and the second surface 1112 are both provided with a smooth coating, the elastic plate body may be disposed in the catheter sheath 10, that is, the first surface 1111 is close to the sheath 12 or the second surface 1112 is close to the sheath 12.

In one example, in order to tightly compress the peripheral portion 1113 of the elastic plate body between the sheath base 112 and the sheath cap 113, a smooth coating is not required on the surface of the peripheral portion 1113 of the elastic plate body, so as to ensure friction between the peripheral portion 1113 of the elastic plate body and the sheath base 112 and the sheath cap 113.

In one embodiment, sheath hub 112 is an axially-extending structure, laterally provided with a connecting end 1121 and connected, for example, by glue connection, to a conduit connected to a communication valve 114 (e.g., adhesive), the function of communication valve 114 including, but not limited to, evacuation, pressure measurement, blood sampling, etc. Likewise, the distal end of the sheath hub 112 is attached (e.g., adhered) to the sheath 12, such as by glue. In addition, the sheath holder 112 is made of a material having good injection molding property, adhesive property, high strength and high heat distortion temperature, specifically, for example, PC (polycarbonate), or a mixed material of PC and ABS (acrylonitrile, butadiene, styrene), and the material is not limited and is selected according to practical situations.

In one embodiment, the sheath cap 113 is formed of a material having a relatively high compressive strength, such that it is capable of effectively compressing the hemostatic valve 111, and the application of a compressive axial force to the hemostatic valve 111 causes the hemostatic valve 111 to collapse inwardly.

Referring to fig. 4, in one embodiment, a point where the central axis (shown as a dotted line O) of the sheath holder 112 intersects with the concave surface 1114 is an intersection point, and the intersection point is connected with any point on the top edge of the inner wall of the sheath holder 112 to form a connection line 1115, where the connection line 1115 is disposed at an angle with the central axis (shown as a dotted line O) of the sheath holder 112, and the angle a between the connection line and the central axis of the sheath holder 112 is a, and the angle a is 15 ° to 75 °. Therefore, when the included angle a is in the angle range, the axial force generated by assembly extrusion counteracts the friction force generated by the elastic plate body when the instrument is withdrawn, so that the eversion preventing effect is better. In addition, the hemostatic and hemostatic stability of the catheter sheath 10 is enhanced.

Referring to fig. 4, in one embodiment, the hemostatic valve 111 is engaged in an assembly gap formed by the sheath cap 113 and the sheath hub 112. In the region where the hemostatic valve 111, the sheath cap 113, and the sheath holder 112 overlap each other in the axial direction of the sheath holder 112, the minimum value of the fitting clearance is H; the minimum value H is smaller than the thickness d of the hemostatic valve 111 before assembly at a position corresponding to the minimum value H assembly gap. In this manner, the assembly clearance will cause axial compression of the hemostatic valve 111, with the hemostatic valve 111 forming a concave surface 1114 that is concave toward the distal end of the catheter sheath 10 due to the elastic properties of its material.

It should be noted that, the hemostatic valve 111 in this embodiment is made of an elastic plate body with the same thickness, that is, the thickness of all parts of the hemostatic valve 111 before assembly is the same, and the thickness is denoted as D, that is, the thickness D is the same as the thickness D.

The position where the fitting clearance of the minimum value H contacts the peripheral portion 1113 of the elastic plate body may be set according to the actual situation, and is not limited herein. In one embodiment, the location where the assembly gap of the minimum value H contacts the peripheral portion 1113 of the elastic plate body is not generally located on the edge of the elastic plate body, so that the fixing effect of the hemostatic valve 111 can be ensured. In addition, the assembly gap with the minimum value H is circumferentially arranged around the axial direction of the sheath seat 112, namely, the assembly gap with the minimum value H is in a ring shape, so that the elastic plate body can be clamped and fixed in one circle, the fixing effect is good, and meanwhile, the processing and the manufacturing can be facilitated.

Referring to fig. 4, in one embodiment, at least one first step 1122 is provided on the sheath hub 112 at a location contacting the elastic plate, and at least one second step 1131 is provided on the sheath cap 113 at a location contacting the elastic plate. In this way, when the elastic plate body is disposed in the assembly gap between the sheath base 112 and the sheath cap 113, the two opposite sides of the peripheral portion 1113 are respectively in close contact with at least the first step 1122 and at least the second step 1131, so that the elastic plate body has high static friction force, can be tightly fixed in the assembly gap, cannot move in the assembly gap, and cannot easily separate from the assembly gap.

The number of the first steps 1122 is not limited, and may be, for example, one to three. Likewise, the number of the second steps 1131 is not limited, and may be one to three, for example.

Referring to fig. 4, in one embodiment, the first surface 1111 is in contact with the sheath cap 113 and the second surface 1112 is in contact with the sheath hub 112; the area of the sheath cap 113 in contact with the first surface 1111 is larger than the area of the sheath hub 112 in contact with the second surface 1112. Therefore, the axial pressure of the elastic plate body can be further given, and the concave effect is synergistically increased; in addition, the elastic plate can be well prevented from being turned outwards when the instrument is withdrawn. Specifically, the area of the sheath cap 113 for contacting the first surface 1111 is a first annular area, the area of the sheath holder 112 for contacting the second surface 1112 is a second annular area, and the projection of the first annular area on the sheath holder 112 can completely cover the second annular area along the axial direction of the sheath holder 112.

Referring to fig. 4, in one embodiment, the sheath cap 113 is snap fit, adhesively secured, or secured with a fastener connection to the sheath mount 112. The fasteners include, but are not limited to, screws, bolts, pins, rivets, etc., and may be selected according to practical situations.

Referring to fig. 4, in one embodiment, the sheath cap 113 includes a cap body 1132 sleeved at one end of the sheath base 112 and a collision plate 1133 connected to one end of the cap body 1132. The interference plate 1133 is provided with a via 11331 for passing an instrument therethrough, and the peripheral portion 1113 of the elastic plate body is tightly and fixedly abutted against the end surface of the sheath base 112. Specifically, one of the cap body 1132 and the sheath holder 112 is provided with a buckle 1134, and the other is provided with a clamping hole 1123 matched with the buckle 1134. So, after the cap body 1132 is sleeved on the end of the sheath seat 112, the cap body 1132 is clamped into the clamping hole 1123 through the buckle 1134, so that the cap body can be quickly and fixedly arranged on the sheath seat 112, and meanwhile, the peripheral part 1113 of the elastic plate body can be tightly abutted against and fixed on the end face of the sheath seat 112 through the abutting plate 1133, so that the assembly operation is more convenient. In order to ensure the fixing effect of the cap body 1132 on the sheath seat 112, the number of the fastening holes 1123 and the fastening holes 1134 is not limited to one, and may be two, three or more. Of course, the engagement hole 1123 may be an annular hole circumferentially provided around the outer wall of the sheath holder 112.

Referring to fig. 4, in one embodiment, the outer wall surface of the end of the sheath 112 for mounting the cap body 1132 is a conical surface 1124 with an outer diameter gradually decreasing in a direction toward the interference plate 1133. Thus, on one hand, the cap body 1132 provides guiding function through the conical surface 1124 during the process of sleeving the cap body on the end part of the sheath holder 112, so that the assembly is convenient; on the other hand, radial expansion of the valve 111 reserves space.

Referring to fig. 5 and 6, fig. 5 is an exploded view of a hemostatic assembly 11 according to another embodiment of the present invention, and fig. 6 is a cross-sectional view of fig. 5 after assembly. The hemostatic assembly 11 shown in fig. 5 and 6 differs from the hemostatic assembly 11 shown in fig. 2-4 mainly in the manner in which the sheath cap 113 is disposed. In one embodiment, the sheath holder 112 is provided with a through hole 1125, and the wall of the through hole 1125 is circumferentially provided with a supporting portion 1126. The sheath cap 113 comprises a cap body 1132 disposed inside the through hole 1125 and a collision plate 1133 connected to one end of the cap body 1132, wherein the collision plate 1133 is provided with a through hole 11331 for passing an instrument therethrough, and is tightly abutted against the peripheral portion 1113 of the elastic plate body to be fixed on the supporting portion 1126. One of the cap body 1132 and the sheath seat 112 is provided with a buckle 1134, and the other is provided with a clamping hole 1123 matched with the buckle 1134.

Referring to fig. 7-10, the hemostatic assembly 11 shown in fig. 7-8 has a pilot valve 115 and a protective housing 117 added to the hemostatic assembly 11 shown in fig. 5-6. In one embodiment, the hemostatic assembly 11 further includes a flexible guide valve 115, the guide valve 115 is disposed inside the cap 1132, a central hole 1151 and a third slit 1152 in communication with the central hole 1151 are disposed in the middle of the guide valve 115, and the central hole 1151 and the third slit 1152 extend through two opposite surfaces of the guide valve 115. Thus, on the one hand, the instrument passes through the pilot valve 115 and then through the hemostatic valve 111 and into the sheath 12; on the other hand, the hemostasis valve 111 plays a first hemostasis role, and the guide valve 115 can further enhance the hemostasis and hemostatic stability of the catheter sheath 10.

Referring to fig. 9 to 12, in one embodiment, the surface of the pilot valve 115 facing the elastic plate body is a third surface 1153, and the third surface 1153 is a spherical surface (as shown in fig. 12) or a conical surface (as shown in fig. 9) concaved away from the elastic plate body. Thus, the guide valve 115 skillfully utilizes the blood pressure of the human body, and when the blood pressure acts on the spherical surface or the inclined surface, the pressure tightly closes the third kerf 1152 and the central hole 1151 and is attached to the outer wall of the instrument, so that the entered instrument is always kept at the central position, and the hemostatic valve 111 is matched with the instrument to always keep good hemostatic performance. In addition, the third surface 1153 cooperates with the first surface 1111 of the hemostatic valve 111 to form a first buffer area 1158, which can effectively perform pressure release buffering, and ensure a better hemostatic effect.

Referring to fig. 9 and 10, in one embodiment, at least one reinforcing rib 1159 is disposed on the third surface 1153. In this manner, the ribs 1159 provide axial support to avoid eversion of the pilot valve 115 due to friction with the pilot valve 115 during withdrawal of the instrument. Specifically, the reinforcing ribs 1159 are, for example, four or other numbers, and the four reinforcing ribs 1159 are uniformly arranged on the third surface 1153 and are each arranged in the radial direction from the center of the third surface 1153. The height of the ribs 1159 is not limited, and may be, for example, 0-3mm, or other values.

Referring to fig. 9 to 12, in one embodiment, the surface of the pilot valve 115 facing away from the elastic plate body is a fourth surface 1154, and the fourth surface 1154 is a concave spherical surface facing toward a direction approaching the elastic plate body. On one hand, the spherical surface plays a role in guiding the instrument, so that the passing compliance of the instrument is enhanced, and the operation requirement of the instrument in the operation is reduced; on the other hand, the fourth surface 1154 forms a cavity, which corresponds to a second buffer zone, reduces the pressure in the catheter sheath 10 and has an auxiliary hemostatic function.

Referring to fig. 8 and 10, the fourth surface 1154 is provided with at least one guide block 11541, the guide block 11541 extends from the edge of the fourth surface 1154 to the central hole 1151, and the guide block 11541 is contacted during insertion of the instrument into the central hole 1151, and the instrument is guided by the guide block 11541 so as to facilitate insertion into the central hole 1151.

Referring to FIG. 10, in one embodiment, the central bore 1151 has a depth L, L+.4mm. The depth L is not greater than 4mm, and the radial pressure is small and the friction force is small when the instrument passes through the central hole 1151, so that the instrument can enter smoothly.

Referring to fig. 8-10, in one embodiment, the outer wall of the pilot valve 115 is circumferentially provided with a groove 1155, and the hemostatic assembly 11 further includes a retaining ring 116 that is adapted to fit within the groove 1155, with the retaining ring 116 being disposed within the groove 1155. Specifically, the fixing ring 116 is a circumferentially closed ring, and is made of a material having high hardness and being not easily deformed, such as PC (polycarbonate), a metal material, or the like. Thus, the inner wall surface of the fixing ring 116 is tightly attached to the outer wall surface of the guide valve 115, and the two end surfaces provide positive pressure for the edge of the guide valve 115 when being pressed, so that the guide valve 115 is prevented from being excessively deformed due to the in-out of an instrument or high pressure, and the function is disabled. In addition, the guide valve 115 is limited by the fixing ring 116, so that the instrument passing through the catheter sheath 10 is ensured to be positioned at the center of the catheter sheath 10, and the hemostatic valve 111 always maintains good hemostatic function.

Referring to fig. 7 and 8, in one embodiment, the hemostatic assembly 11 further includes a protective housing 117 removably coupled to the sheath hub 112. One end of the protective housing 117 is inserted into the cap body 1132, and the other end of the protective housing 117 is located outside the cap body 1132. The outer wall of the protective housing 117 is provided with a third step 1171, and the third step 1171 is abutted against one end of the cap body 1132 far away from the abutting plate 1133. Specifically, the protective housing 117 is made of a polymer material, for example, the protective housing 117 is added to the outer side of the guide valve 115, a semi-open space 1172 formed between the protective housing 117 and the guide valve 115 can avoid high-pressure blood spraying phenomenon caused when an instrument is withdrawn, and the problem of blood spraying when the instrument enters and exits a human body is solved, so that the operation difficulty of the instrument is reduced, blood loss of a patient in operation is effectively reduced, the operation of a doctor is effectively avoided, the operation risk is reduced, and the universality of the catheter sheath 10 in clinical application is improved.

In addition, since the end of the protective shell 117 is located outside of the sheath hub 112, the instrument is convenient to operate relative to the increased graspable length of the hemostatic assembly 11.

The protective shell 117 is, for example, a shell-shaped bidirectional through structure as shown in fig. 8, and meets the passing requirements of various instruments. In addition, the protective housing 117 is detachably connected to the sheath 112 by a fastener 1134 or a screw thread, and is formed with a semi-open space 1172 in cooperation with the sheath 112, and referring to fig. 7, the axial length M of the semi-open space 1172 ₁ Preferably greater than the guidingLength M of valve 115 ₂ But not exceeding the total length M of the sheath 112 ₃ 1/2 of (C). The advantage of this design lies in longer axial length can effectively carry out pressure release buffering, and the whole has better supportability, is convenient for hold the operation. The material is preferably a hard, lightweight polymeric material such as PC (polycarbonate).

Referring to fig. 6 to 8, in one embodiment, a first thread 1173 is provided on an outer wall of the protective housing 117, a second thread 1127 corresponding to the first thread 1173 is provided on a hole wall of the through hole 1125, and the protective housing 117 is detachably disposed on the sheath base 112 through the first thread 1173 and the second thread 1127.

There are two operational situations in which the catheter sheath 10 is passed through by a small-sized instrument and passed through by a large-sized instrument. Wherein the hemostatic valve 111 plays a major hemostatic role when a small-sized instrument is passed therethrough, and the guide valve 115 plays a major limiting role, preventing the hemostatic instability of the catheter sheath 10 due to the eccentricity generated when the instrument is operated. When a large-size instrument passes through, the hemostatic valve 111 and the guide valve 115 play a hemostatic role at the same time, and the guide valve 115 still has an auxiliary limiting function, so that good hemostatic performance is ensured.

The technical features of the above embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above 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.

In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present invention, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

Claims

1. A hemostatic assembly, comprising a hemostatic valve, a sheath seat and a sheath cap disposed on the sheath seat; the hemostatic valve comprises an elastic plate body, wherein the elastic plate body is provided with a middle part and a peripheral part which is arranged around the middle part, and the peripheral part is tightly arranged between the sheath seat and the sheath cap; under the compression of the sheath seat and the sheath cap to the peripheral part, a concave surface is formed at the middle part.

2. The hemostatic assembly of claim 1, wherein the elastic plate body has a first surface and a second surface opposite to each other, the first surface has at least one first slit, the first slit does not extend through to the second surface, the second surface has at least one second slit, the second slit does not extend through to the first surface, the first slit and the second slit are disposed to intersect, and a combination slit of intersection positions of the first slit and the second slit extends through from the first surface to the second surface.

3. The hemostatic assembly of claim 2, wherein the elastic plate has a thickness D and the first slit has a depth S ₁ The depth of the second kerf is S ₂ ，S ₁ <D,S ₂ <D,S ₁ +S ₂ ≥D。

4. A hemostatic assembly according to claim 3, wherein the depth S ₁ Depth S ₂ The following relationships are satisfied with the thickness D: 0.3D<S ₁ <0.9D,0.3D<S ₂ <0.9D。

5. The hemostatic assembly of claim 2, wherein the first slit is one and the second slit is one.

6. The hemostatic assembly of claim 2, wherein the elastic plate body is a silicone plate or a rubber plate.

7. The hemostatic assembly of claim 1, wherein the point at which the central axis of the sheath hub intersects the concave surface is an intersection point, the intersection point is connected with any point on the top edge of the inner wall of the sheath hub to form a line, the line is disposed at an angle with the central axis of the sheath hub, the line forms an angle a with the central axis of the sheath hub, and the angle a is 15 ° to 75 °.

8. The hemostatic assembly of claim 1, wherein the hemostatic valve is snapped into an assembly gap formed by the sheath cap and the sheath hub; in the region where the hemostatic valve, the sheath cap and the sheath seat overlap each other in the axial direction of the sheath seat, the minimum value of the assembly gap is H; the thickness of the position on the hemostatic valve, which is in contact with the assembly clearance with the minimum value H, before assembly is d, and H < d.

9. The hemostatic assembly of claim 1, wherein the sheath seat has at least one first step at a location in contact with the elastomeric sheet and the sheath cap has at least one second step at a location in contact with the elastomeric sheet.

10. The hemostatic assembly of claim 1, wherein the elastomeric sheet has opposing first and second surfaces, the first surface being in contact with the sheath cap and the second surface being in contact with the sheath hub; the area of the sheath cap, which is contacted with the first surface, is larger than the area of the sheath seat, which is contacted with the second surface.

11. The hemostatic assembly of claim 1, wherein the sheath cap is snap fit, adhesively secured, or secured with a fastener connection to the sheath mount.

12. The hemostatic assembly of claim 11, wherein the sheath cap comprises a cap body sleeved at one end of the sheath base and a collision plate connected with one end of the cap body; the interference plate is provided with a through hole for passing an instrument, and the peripheral part of the elastic plate body is closely and fixedly abutted against the end surface of the sheath seat; one of the cap body and the sheath seat is provided with a buckle, and the other is provided with a clamping hole matched with the buckle.

13. The hemostatic assembly of claim 12, wherein the outer wall surface of the end of the sheath for receiving the cap is a conical surface having an outer diameter that tapers in a direction toward the interference plate.

14. The hemostatic assembly of claim 11, wherein the sheath seat is provided with a through hole, and the wall of the through hole is circumferentially provided with a support; the sheath cap comprises a cap body arranged in the through hole and a collision plate connected with one end of the cap body, wherein the collision plate is provided with a through hole for an instrument to pass through and is tightly and fixedly connected with the periphery of the elastic plate body on the supporting part in a collision manner; one of the cap body and the sheath seat is provided with a buckle, and the other is provided with a clamping hole matched with the buckle.

15. The hemostatic assembly of claim 6, further comprising a pilot valve disposed within the sheath seat, a central aperture and a third slit in communication with the central aperture, the central aperture and the third slit extending through opposite surfaces of the pilot valve.

16. The hemostatic assembly of claim 15, wherein the surface of the guide valve facing the elastic plate body is a third surface that is a spherical or conical surface concave toward a direction away from the elastic plate body.

17. The hemostatic assembly of claim 16, wherein a surface of the guide valve facing away from the elastic plate body is a fourth surface, the fourth surface being a spherical or conical surface concave toward a direction proximate to the elastic plate body.

18. The hemostatic assembly of claim 15, wherein the outer wall of the guide valve is circumferentially provided with a groove, and the hemostatic assembly further comprises a retaining ring adapted to the groove, the retaining ring being disposed within the groove.

19. The hemostatic assembly of claim 15, further comprising a protective shell removably coupled to the sheath hub; one end of the protective shell is inserted into the sheath seat, and the other end of the protective shell is positioned outside the sheath seat; the outer wall of the protective housing is provided with a third step, and the third step is in contact with one end of the sheath seat.

20. A hemostatic valve, the hemostatic valve comprising:

the elastic plate body is provided with a first surface and a second surface which are opposite, the first surface is provided with at least one first slit, the first slit does not extend to the second surface in a penetrating way, the second surface is provided with at least one second slit, the second slit does not extend to the first surface in a penetrating way, the first slit and the second slit are arranged in a crossing way, a combined slit at the crossing position of the first slit and the second slit penetrates to the second surface from the first surface, and under the compression of the peripheral part of the elastic plate body, a concave surface can be formed at the middle part of the elastic plate body.

21. A catheter sheath comprising the hemostatic assembly of any one of claims 1-19, further comprising a sheath tube coupled to the hub.