CN113116499B

CN113116499B - Ostomy appliance and ostomy system

Info

Publication number: CN113116499B
Application number: CN201911412819.8A
Authority: CN
Inventors: 刘鹏; 石亚洲; 单烁
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-12-31
Filing date: 2019-12-31
Publication date: 2023-05-02
Anticipated expiration: 2039-12-31
Also published as: CN113116499A

Abstract

The invention relates to an ostomy appliance and a ostomy system, the ostomy appliance comprising a cutting member and a control member, the cutting member being radially self-expandable, the control member being slidably connected to the cutting member, the control member being slidably compressible with respect to the control member. The ostomy appliance of the invention can be adapted to the requirements of different patients for different stoma sizes.

Description

Ostomy appliance and ostomy system

Technical Field

The present invention relates to the field of interventional medicine, and in particular to an ostomy appliance and ostomy system.

Background

Heart failure (abbreviated heart failure) is a complex clinical syndrome of impaired ventricular filling or ejection function due to structural or functional abnormalities of the heart, which is mainly manifested clinically by dyspnea and hypodynamia (activity tolerance), and fluid retention (pulmonary congestion and peripheral edema). Heart failure is becoming the most important cardiovascular condition worldwide as a serious stage of the development of various heart diseases.

Heart failure includes diastolic heart failure. Diastolic heart failure refers to a condition where ventricular relaxation and compliance decrease in normal ventricular contractility, resulting in decreased ventricular filling and increased filling pressure, leading to pulmonary and systemic congestion syndrome. Diastolic heart failure can result in an elevated pressure in the left atrium, impeding the normal flow of oxygenated blood.

When heart failure occurs, the left and right atria can be connected by implanting an opening device in the atrial septum to create a left-to-right shunt. Using this method, an interatrial septum stoma is performed, and the aperture of the opening device cannot be adjusted intraoperatively, resulting in inapplicability to all patients.

Disclosure of Invention

Based on this, it is necessary to provide an ostomy appliance which can be adapted to the requirements of different patients for different stoma sizes.

An ostomy appliance comprising a cutting member and a control member, the cutting member being radially self-expandable, the control member being slidably connected to the cutting member, the control member being slidably compressible with respect to the cutting member.

In one embodiment, the control assembly comprises a control member and a driving member, the control member is connected with the driving member, the cutting assembly is sleeved on the outer side of the driving member, the driving member can drive the control member to slide relative to the cutting assembly, and the control assembly can slide to radially compress the cutting assembly.

In one embodiment, the distal end of the driver extends through the cutting assembly in an axial direction of the cutting assembly, and the control member is coupled to the driver on a distal side of the cutting assembly.

In one embodiment, the cutting assembly comprises a cutting member and an operating member, the cutting member surrounds the periphery of the operating member, the distal end of the cutting member is connected with the operating member, the proximal end of the cutting member is radially expandable, and the proximal end of the cutting member is in a wave-shaped annular structure.

In one embodiment, the ostomy appliance further comprises a release prevention assembly, the release prevention assembly comprises a release prevention claw, the distal end of the release prevention claw is connected with the operating member, the proximal end of the release prevention claw extends towards the proximal end side of the operating member along a curve, and a tangent line passing through any point on the release prevention claw is located on the outer side of the release prevention claw along the direction from the distal end to the proximal end of the release prevention claw.

In one embodiment, the anti-disengagement pawl comprises a first portion and a second portion that are connected, the distal end of the first portion being connected to the operating member, the proximal end of the first portion being connected to the second portion, the projection of the proximal end of the second portion being located proximally of the projection of the proximal end of the cutting member in a plane of projection parallel to the central axis of the operating member.

In one embodiment, the curvature of the first portion increases gradually and the curvature of the second portion decreases gradually along the extension of the distal end of the anti-slip pawl to the proximal end thereof.

In one embodiment, the anti-disengagement assembly further comprises a mating member slidably connected to the anti-disengagement pawl, the mating member is of tubular configuration, the mating member is located on a distal side of the anti-disengagement pawl, and the mating member slides toward a proximal end of the operating member to radially compress the anti-disengagement pawl.

In one embodiment, the anti-drop assembly further comprises an anchor spike connected to the second portion, the anchor spike extending in a direction forming an angle θ with a tangential direction to a distal end of the second portion, 0 ° < θ < 180 °.

In one embodiment, there is also provided an ostomy system comprising a delivery sheath and an ostomy appliance as described above.

When the ostomy appliance is used, the cutting assembly is used for cutting the atrial septum tissue, and the partial tissue on the atrial septum tissue is cut off, so that the ostomy of the atrial septum tissue is achieved, the pressure of the left atrium of a patient suffering from diastolic heart failure is reduced, the control assembly radially slides relative to the cutting assembly to radially compress the cutting assembly, and the size of the stoma formed by the cutting assembly is controlled, so that the ostomy appliance is suitable for the requirements of different patients on different stoma sizes.

Drawings

FIG. 1 is a schematic cut-away view of an ostomy appliance and delivery sheath in one embodiment.

Fig. 2 is a schematic structural view of a cutting assembly in an embodiment.

Fig. 3 is a schematic structural view of a cutting assembly and an anti-drop assembly in an embodiment.

Fig. 4 is a schematic structural view of the anti-falling claw in an embodiment.

Fig. 5 is a schematic view in cross-section of an ostomy appliance of a second 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.

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," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

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. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

For purposes of more clarity in describing the structure of the present invention, the terms "distal" and "proximal" are used as terms of orientation which are conventional in the art of interventional medical devices, wherein "distal" refers to the end of the procedure that is remote from the operator and "proximal" refers to the end of the procedure that is proximal to the operator.

The axial direction refers to a direction parallel to a connecting line of the distal center and the proximal center of the medical instrument; the radial direction refers to a direction perpendicular to the axial direction.

First embodiment

Referring to fig. 1, the present embodiment provides an ostomy appliance 100 that may be delivered to a desired site via a delivery sheath 210. Delivery sheath 210 has a delivery lumen 211, and ostomy appliance 100 is slidably coupled to delivery sheath 210, with ostomy appliance 100 being shuttled within delivery lumen 211.

The ostomy appliance 100 comprises a cutting assembly 110, a control assembly 130 and an anti-slip assembly 150 connected. The cutting assembly 110 is used to cut the atrial septum tissue, resecting a portion of tissue from the atrial septum tissue, and thereby making an incision in the atrial septum tissue. The control assembly 130 cooperates with the cutting assembly 110 for controlling the size of the stoma formed by the cutting assembly 110 to accommodate different patient requirements for the stoma size. During the cutting of atrial septum tissue by cutting assembly 110, anti-sloughing assembly 150 may prevent blood flow from flushing resected atrial septum tissue from the instrument to sloughing, and may further prevent thrombus from forming after the atrial septum tissue sloughing.

Specifically, the cutting assembly 110 may be radially self-expanding, and the proximal end of the cutting assembly 110 may be in contact with atrial septum tissue to cut it, enabling the creation of an stoma in the atrial septum tissue, communicating the left atrium with the right atrium, to create a left-to-right shunt that may reduce the pressure in the left atrium of a diastolic heart failure patient.

Referring to fig. 2, cutting assembly 110 includes a cutting member 111 and an operating member 117 coupled together.

Specifically, the cutting member 111 includes a plurality of links 112 and a wave ring 113, the links 112 are arranged along the circumference of the wave ring 113, the proximal ends of the links 112 are connected to the wave ring 113, and the distal ends of the links 112 are gathered together such that the diameter of the distal end of the cutting member 111 is smaller than the diameter of the proximal end thereof. The connecting rod 112 is connected to the undulating ring 113 so that the proximal end of the cutting member 111 forms an annular configuration and so that the cutting member 111 is radially self-expandable ("radially self-expanding" may also be referred to as "radially expanding") and radially compressively deformable. When in manufacture, the cutting piece 111 can be formed by cutting a nickel-titanium alloy tube by laser to form a connecting rod 112 and a wave ring 113 which are connected, and then the diameter of the cutting piece 111 at the distal end is smaller than the diameter of the cutting piece at the proximal end by heat setting, so that the diameter of the cutting piece 111 gradually increases from the distal end to the proximal end.

The cutting member 111 further includes an electrode (not shown) disposed on the proximal end of the wavy ring 113, and when the cutting member 111 is moved to contact the atrial septum tissue, the electrode heats up after being energized, so that a portion of the tissue can be excised from the atrial septum tissue, thereby making an incision in the atrial septum.

The operating member 117 is of tubular construction, the operating member 117 is slidably coupled to the delivery sheath 210, and the operating member 117 slides relatively along the delivery lumen 211 to release or retract the cutting assembly 110. The cutting member 111 has an annular configuration surrounding the outer periphery of the operating member 117, and the distal end of the cutting member 111 is connected to the outer wall of the operating member 117. The operating member 117 is axially movable to move the cutting member 111. For example, after the cutting member 111 has passed through the atrial septum and into the left atrium, the operating member 117 may be moved proximally, which may cause the electrode at the proximal end of the cutting member 111 to move proximally into contact with the atrial septum tissue, thereby cutting the atrial septum tissue.

The control assembly 130 is slidably connected to the cutting assembly 110, and the control assembly 130 can radially compress the cutting assembly 110 relative to the cutting assembly 110, thereby changing the diameter of the cutting assembly 110 and thus the aperture of the stoma, and further enabling the ostomy appliance 100 of the present embodiment to form different stoma sizes for the room compartments according to different patient needs.

Referring again to fig. 1, the control assembly 130 includes a control member 131 and a driving member 133, wherein the control member 131 is connected to the driving member 133, and the driving member 133 can drive the control member 131 to radially compress the cutting member 111 or cancel the radial compression of the cutting member 111.

Specifically, the control member 131 is a tubular structure, the inner diameter of the control member 131 is larger than the diameter of the distal end of the cutting member 111, and the inner diameter of the control member 131 is smaller than the diameter of the proximal end of the cutting member 111. The control member 131 is connected to the driving member 133 at the distal end side of the cutting assembly 110, and in particular, the control member 131 is connected to the driving member 133 at the distal end side of the cutting member 111. The control member 131 is moved by the driving member 133 towards the proximal side of the ostomy appliance 100, and the proximal end of the control member 131 radially compresses the portion of the cutting member 111 having a larger diameter than the inner diameter of the control member 131, thereby reducing the diameter of the distal wave ring 113, i.e. the stoma size of the ostomy appliance 100.

The driver 133 is a tubular or rod-like structure with the distal end of the driver 133 extending through the cutting assembly 110 in the axial direction of the cutting assembly 110. The driving member 133 is nested inside the cutting assembly 110, i.e. the cutting assembly 110 is sleeved outside the driving member 133, the driving member 133 can drive the control member 131 to slide relative to the cutting assembly 110, and the control member 131 can apply a radial compression force to the cutting member 111 or cancel the radial compression force applied to the cutting member 111.

Specifically, the driving member 133 is nested inside the operating member 117, and the driving member 133 can slide along the operating member 117, so as to drive the control member 131 to slide relative to the cutting member 111, so that the cutting member 111 can be radially compressed or not radially compressed.

Referring to fig. 3, the anti-slip assembly 150 includes an anti-slip claw 151, a mating member 155, a traction member 157, and an anchor 159 connected thereto.

The distal end of the escape prevention claw 151 is connected to the operation member 117, and in a projection plane parallel to the central axis plane of the operation member 117, the projection of the proximal end of the escape prevention claw 151 is located on the projection proximal end side of the proximal end of the cutting member 111, that is, the distance between projections of the proximal end of the escape prevention claw 151 to the distal end of the cutting member 111 is larger than the distance between projections of the proximal end of the cutting member 111 to the distal end of the cutting member 111. Further, before the electrode of the cutting member 111 is brought into contact with the atrial septum tissue, the escape prevention claw 151 is brought into contact with the atrial septum tissue and penetrates into the tissue, so that the escape prevention claw 151 is anchored to the atrial septum tissue, and thus, the atrial septum tissue is prevented from escaping.

Specifically, referring to fig. 4, the anti-disengaging pawl 151 includes a first portion 153 and a second portion 154 connected to each other, a distal end of the first portion 153 is connected to the operation member 117, a proximal end of the first portion 153 is connected to the second portion 154, and a projection of the proximal end of the second portion 154 is located on a projection proximal side of a proximal end of the cutting member 111 in a projection plane parallel to a central axis plane of the operation member 117. Such that the proximal end of the second portion 154 may penetrate into the atrial septum tissue to ensure that the atrial septum tissue does not fall off of the second portion 154 during the cutting process.

The distal end of the anti-falling jaw 151 extends toward the proximal end thereof, and along the extending direction of the anti-falling jaw 151, the curvature of the first portion 153 is gradually increased, so that the flexibility of the first portion 153 is gradually increased, when the anti-falling jaw 151 needs to be recovered and enters the delivery sheath 210, the anti-falling jaw 151 can be conveniently compressed radially, the resistance of the anti-falling jaw 151 for recovering the sheath can be reduced, and the anti-falling jaw 151 is further conveniently inserted into the sheath.

Along the extending direction of the anti-falling claw 151, the curvature of the second portion 154 gradually decreases, so that the flexibility of the second portion 154 gradually decreases, and the anti-falling claw 151 can provide enough strength under the condition of enough flexibility, so that the tissue on the anti-falling claw 151 is prevented from falling off due to the interference of external force. And the gradual decrease in curvature of the second portion 154 also ensures that the proximal end of the second portion 154 maintains an approximately straight configuration, thereby allowing the proximal end of the second portion 154 to penetrate into the atrial septum. More specifically, the flexibility of the first portion 153 is greater than that of the second portion 154, so that the first portion 153 can provide flexibility to facilitate the sheathing of the anti-falling jaw 151, and the second portion 154 provides strength to enhance the anti-falling effect of the anti-falling jaw 151.

The number of the anti-falling claws 151 is multiple, the anti-falling claws 151 encircle the periphery of the operating piece 117 and are connected with the operating piece, the distance from any anti-falling claw 151 to the operating piece 117 is gradually increased along the direction from the distal end to the proximal end of the anti-falling claw 151, so that the anti-falling claws 151 form a gradually gathered structure from the proximal end to the distal end, and further, the separation tissues of a room are prevented from falling off.

The tangent line passing through any point on the anti-falling claw 151 is positioned outside the anti-falling claw 151, namely, the curve formed by the anti-falling claw 151 is a convex arc. Thus, when the anti-falling claw 151 is compressed radially, the anti-falling claw 151 can not only generate radial compression deformation, but also extend to the proximal end, so that the atrial septum tissue is pushed to the proximal end, the atrial septum tissue is convenient to enter the sheath, and the atrial septum tissue entering the delivery sheath 210 can not fall off. Note that the tangential line passing through any point on the escape prevention claw 151 is located outside the escape prevention claw 151 means that the escape prevention claw 151 is located between the tangential line thereof and the operation member 117.

The anchor 159 is connected to the second portion 154, and an included angle θ is formed between an extending direction of the anchor 159 and a tangential direction of a distal end of the second portion 154, where θ is 0 ° < 180 °, and the anchor 159 can increase a contact area of the anti-release pawl 151 with the atrial septum, so that when the anti-release pawl 151 pushes the atrial septum proximally, the anti-release pawl 151 can be prevented from piercing the atrial septum, and further, the anti-release pawl 151 can push the atrial septum proximally. When radially compressing the anti-slip out jaw 151, 0 < θ < 180 °, the anchor 159 may be folded with the second portion 154 (i.e., θ becomes smaller) without increasing the radial dimension of the anti-slip out jaw 151.

Referring to fig. 3 again, in this embodiment, the engaging member 155 is in a tubular structure, the engaging member 155 is sleeved on the periphery of the operating member 117, the engaging member 155 is slidably connected with the anti-falling jaw 151, the engaging member 155 is located at the distal end side of the anti-falling jaw 151, and the engaging member 155 can slide towards the proximal end of the operating member 117 through the traction member 157 to radially compress the anti-falling jaw 151, so that the anti-falling jaw 151 applies a radial tightening force to the tissue of the room, and the connection firmness of the anti-falling jaw 151 and the tissue of the room is increased. And the anti-falling claw 151 is radially compressed, so that the anti-falling claw 151 with a convex arc can be radially compressed and deformed, and can also stretch towards the proximal end to push the atrial septum into the sheath towards the proximal end.

In this embodiment, the traction member 157 is a tube structure that is sleeved outside the operation member 117, the traction member 157 is slidably connected to the operation member 117, and the engaging member 155 is connected to the traction member 157. The traction member 157 is provided with a clearance hole 158, and the escape prevention claw 151 passes through the clearance hole 158 to be connected with the operation member 117.

Second embodiment

This embodiment differs from the first embodiment in the structure of the control assembly 330 and the operating member 317.

Specifically, the control component 330 is connected with the cutting component 310, the control component 330 is arranged on the inner side of the cutting component 310, and the control component 330 can radially expand to radially expand the cutting component 310, so that the stoma size of the cutting component 310 can be changed, and the requirements of different patients on the stoma size can be met.

The control assembly 330 in this embodiment includes a radially expandable control member 331, rather than the drive member 133 of the first embodiment. The control member 331 is connected to the operation member 317 in the cutting assembly 310, the control member 331 is disposed outside the operation member 317, and the control member 331 is disposed inside the cutting member 311, so that radial expansion of the control member 331 can radially expand the cutting member 311.

In particular, the control member 331 may be a balloon, the control member 331 having a radially expandable lumen 332. The operating member 317 has a filling channel 318 formed therein, the filling channel 318 being in communication with the chamber capsule 332, the distal end of the operating member 317 being a closed end. Filling material (e.g., gas, contrast agent, saline, etc.) may be introduced from filling channel 318 into bladder 332, thereby radially expanding control element 331.

Third embodiment

The present embodiment also provides an ostomy system comprising an ostomy appliance (ostomy appliance 100 and ostomy appliance 300) as described above and a delivery 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

1. An ostomy appliance comprising a cutting assembly and a control assembly, said cutting assembly being radially self-expandable, said control assembly being slidably connected to said cutting assembly, said control assembly being slidably movable relative to said cutting assembly to radially compress said cutting assembly; the control assembly comprises a control piece and a driving piece, the control piece is connected with the driving piece, the cutting assembly is sleeved on the outer side of the driving piece, the driving piece can drive the control piece to slide relative to the cutting assembly, and the control assembly can slide to radially compress the cutting assembly.

2. The ostomy appliance of claim 1, wherein the distal end of the driving member extends through the cutting assembly in an axial direction of the cutting assembly, and wherein the control member is connected to the driving member at a distal side of the cutting assembly.

3. The ostomy appliance of claim 1, wherein the cutting assembly comprises a cutting member and an operating member, the cutting member surrounding the periphery of the operating member, a distal end of the cutting member being connected to the operating member, a proximal end of the cutting member being radially expandable, the proximal end of the cutting member being of a wavy annular configuration.

4. An ostomy appliance as claimed in claim 3, wherein the ostomy appliance further comprises a release preventing assembly comprising a release preventing jaw, the distal end of the release preventing jaw being connected to the operating member, the proximal end of the release preventing jaw extending along a curve towards the proximal side of the operating member, the tangents to any point on the release preventing jaw being located outside the release preventing jaw in the direction from the distal end to the proximal end of the release preventing jaw.

5. The ostomy appliance of claim 4, wherein the anti-slip pawl comprises a first portion and a second portion connected, a distal end of the first portion being connected to the operating member and a proximal end of the first portion being connected to the second portion, a projection of the proximal end of the second portion being located proximally of a projection of the proximal end of the cutting member in a plane of projection parallel to a central axis of the operating member.

6. The ostomy appliance of claim 5, wherein the curvature of the first portion increases gradually and the curvature of the second portion decreases gradually along the extension of the distal end of the anti-backup pawl to the proximal end thereof.

7. The ostomy appliance of claim 5, wherein the anti-backup assembly further comprises a mating member slidably coupled to the anti-backup pawl, the mating member being of tubular configuration, the mating member being located distally of the anti-backup pawl, sliding the mating member proximally of the operating member radially compressing the anti-backup pawl.

8. The ostomy appliance of claim 7, wherein the anti-slip assembly further comprises an anchor, the anchor being connected to the second portion, the anchor extending at an angle θ with respect to a tangent to a distal end of the second portion, 0 ° < θ < 180 °.

9. An ostomy system comprising a delivery sheath and an ostomy appliance according to any one of claims 1 to 8.