CN113116499A - Ostomy appliance and ostomy system - Google Patents
Ostomy appliance and ostomy system Download PDFInfo
- Publication number
- CN113116499A CN113116499A CN201911412819.8A CN201911412819A CN113116499A CN 113116499 A CN113116499 A CN 113116499A CN 201911412819 A CN201911412819 A CN 201911412819A CN 113116499 A CN113116499 A CN 113116499A
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- cutting
- assembly
- ostomy appliance
- proximal end
- disengagement
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
Abstract
The present invention relates to an ostomy appliance and an ostomy system, the ostomy appliance comprising a cutting assembly which is radially self-expandable and a control assembly slidably connected to the cutting assembly, the control assembly slidably compressing the cutting assembly radially relative to the control assembly. The ostomy appliance of the invention can accommodate different patient requirements for different stoma sizes.
Description
Technical Field
The present invention relates to the field of interventional medicine, in particular to an ostomy appliance and an ostomy system.
Background
Heart failure (abbreviated as heart failure) is a complex clinical syndrome of impaired ventricular filling or ejection function due to structural or functional abnormalities of the heart, with major clinical manifestations of dyspnea and weakness (limited exercise tolerance), and fluid retention (pulmonary congestion and peripheral edema). Heart failure is becoming the most important cardiovascular disorder worldwide as a serious stage in the development of various heart diseases.
Heart failure includes diastolic heart failure. Diastolic heart failure refers to a condition in which ventricular contraction functions normally, and ventricular relaxation and compliance decrease lead to a decrease in ventricular filling volume and an increase in filling pressure, resulting in pulmonary and systemic circulatory congestion syndromes. Diastolic heart failure can cause pressure in the left atrium to rise, preventing the normal flow of oxygenated blood.
After heart failure has occurred, the left and right atria can be connected by implanting a separate port instrument in the interatrial septum to create a left-to-right shunt. When the method is used for atrial septal stoma, the aperture of the opening device cannot be adjusted during the operation, so that the method cannot be applied to all patients.
Disclosure of Invention
In view of this, there is a need for an ostomy appliance that can accommodate the different stoma size requirements of different patients.
An ostomy appliance includes a cutting assembly that is radially self-expandable and a control assembly slidably coupled to the cutting assembly that slidably compresses the cutting assembly radially relative to the cutting assembly.
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 outside 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 driving member extends through the cutting assembly in an axial direction of the cutting assembly, and the control member is connected to the driving member at a distal side of the cutting assembly.
In one embodiment, the cutting assembly includes a cutting member and an operating member, the cutting member surrounds the outer periphery of the operating member, the distal end of the cutting member is connected to the operating member, the proximal end of the cutting member is radially expandable, and the proximal end of the cutting member is in a wavy annular configuration.
In one embodiment, the ostomy appliance further comprises an anti-falling component, the anti-falling component comprises an anti-falling claw, the distal end of the anti-falling claw is connected with the operating part, the proximal end of the anti-falling claw extends towards the proximal end side of the operating part along a curve, and a tangent line passing any point on the anti-falling claw is positioned outside the anti-falling claw along the direction from the distal end to the proximal end of the anti-falling claw.
In one embodiment, the anti-release claw includes a first portion and a second portion connected to each other, a distal end of the first portion is connected to the operating member, a proximal end of the first portion is connected to the second portion, and a projection of a proximal end of the second portion is located on a projection proximal side of a proximal end of the cutting member in a projection plane parallel to a center axis plane of the operating member.
In one embodiment, the first portion has a gradually increasing curvature and the second portion has a gradually decreasing curvature along a direction extending from the distal end of the anti-slip claw to the proximal end thereof.
In one embodiment, the locking assembly further comprises a fitting member slidably coupled to the locking pawl, the fitting member being tubular and located on a distal side of the locking pawl, the fitting member being slidable toward a proximal end of the operating member to radially compress the locking pawl.
In one embodiment, the anti-drop assembly further comprises an anchor, the anchor is connected with the second part, the extension direction of the anchor forms an included angle theta with the tangential direction of the far end of the second part, and the angle theta is more than 0 degrees and less than 180 degrees.
In one embodiment, there is also provided an ostomy system comprising a delivery sheath and an ostomy appliance as described above.
When the above-mentioned ostomy instrument used, its cutting assembly was used for cutting interatrial septum tissue, with the excision of the part tissue on the interatrial septum tissue to the stoma to interatrial septum tissue, and then reach the pressure that reduces diastolic heart failure patient's left atrium, but the control module is for the radial compression cutting assembly of cutting assembly radial sliding, and then the size of the mouth is made in the control cutting assembly formation, thereby the requirement of different patients to the different stoma sizes is made in the adaptation.
Drawings
Figure 1 is a cutaway schematic view of an ostomy appliance and a delivery sheath in one embodiment.
Fig. 2 is a schematic structural diagram of a cutting assembly in an embodiment.
Fig. 3 is a schematic structural diagram of the cutting assembly and the anti-slip assembly in an embodiment.
Fig. 4 is a schematic structural view of the anti-separation claw in an embodiment.
Figure 5 is a cut-away schematic view of an ostomy appliance according to a second embodiment.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.
It will be understood that when an element is referred to as being "secured to" 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 as used herein are for illustrative purposes only and do not represent the only embodiments.
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. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
To more clearly describe the structure of the present invention, the terms "distal" and "proximal" are used as terms of orientation that are conventional in the field of interventional medical devices, wherein "distal" refers to the end that is distal from the operator during the procedure and "proximal" refers to the end that is proximal to the operator during the procedure.
The axial direction refers to the direction parallel to the connecting line of the center of the far end and the center of the near end of the medical instrument; the radial direction means 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 location through a delivery sheath 210. The delivery sheath 210 has a delivery lumen 211, and the ostomy appliance 100 is slidably coupled to the delivery sheath 210, and the ostomy appliance 100 is slidably shuttled within the delivery lumen 211.
The ostomy appliance 100 includes a cutting assembly 110, a control assembly 130 and a retaining assembly 150 connected thereto. The cutting assembly 110 is used to cut the atrial septum tissue to remove a portion of the tissue from the atrial septum tissue to create an ostium of the atrial septum tissue. The control assembly 130 cooperates with the cutting assembly 110 to control the size of the stoma formed by the cutting assembly 110 to accommodate the stoma size requirements of different patients. In the process of cutting the interatrial septum tissue by the cutting assembly 110, the anti-dropping assembly 150 can prevent the blood flow from washing the resected interatrial septum tissue off the instrument to drop, and further prevent the interatrial septum tissue from forming thrombus after dropping.
Specifically, the cutting assembly 110 is radially self-expandable, and the proximal end of the cutting assembly 110 can contact with the atrial septum tissue to cut the atrial septum tissue, thereby achieving the purpose of making an ostium to the atrial septum tissue to communicate the left atrium with the right atrium, so as to form left-to-right shunting and further reduce the pressure in the left atrium of the patient with diastolic heart failure.
Referring to fig. 2, the cutting assembly 110 includes a cutting member 111 and an operating member 117 connected to each other.
Specifically, the cutting member 111 includes a plurality of links 112 and a wave-shaped ring 113, the number of the links 112 is plural, the plurality of links 112 are arranged along the circumference of the wave-shaped ring 113, the proximal ends of the links 112 are connected to the wave-shaped 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 linkage 112 is coupled to the undulating ring 113 such that the proximal end of the cutting element 111 forms an annular configuration and such that the cutting element 111 is radially self-expandable ("radially self-expandable" may also be referred to as "radially expandable") and radially compressively deformable. During manufacturing, the cutting member 111 may be formed by laser cutting a nitinol tube into a connecting rod 112 and a corrugated ring 113, and then heat setting is performed such that the diameter of the cutting member 111 at the distal end thereof is smaller than the diameter of the proximal end thereof, and the diameter of the cutting member 111 gradually increases from the distal end thereof to the proximal end thereof.
The control assembly 130 is slidably coupled to the cutting assembly 110, and sliding the control assembly 130 relative to the cutting assembly 110 radially compresses the cutting assembly 110, thereby changing the diameter of the cutting assembly 110 and thus the stoma size, further enabling the ostomy appliance 100 of this embodiment to form different stoma sizes for atrial 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, the control member 131 is connected to the driving member 133, and the driving member 133 can drive the control member 131 to move to radially compress the cutting member 111 or to release 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 element 131 is connected to the driving element 133 at a distal side of the cutting element 110, and specifically, the control element 131 is connected to the driving element 133 at a distal side of the cutting element 111. The control member 131 is moved towards the proximal side of the ostomy appliance 100 by the driving member 133, and the proximal end of the control member 131 radially compresses a portion of the cutting member 111 having a diameter larger 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 driving member 133 is a tubular structure or a rod-shaped structure, and a distal end of the driving member 133 penetrates the cutting assembly 110 along an axial direction of the cutting assembly 110. The driving element 133 is nested inside the cutting element 110, that is, the cutting element 110 is nested outside the driving element 133, the driving element 133 can drive the control element 131 to slide relative to the cutting element 110, and the control element 131 can apply radial compressive force to the cutting element 111 or cancel the application of radial compressive force to the cutting element 111.
Specifically, the driving element 133 is nested in the operating element 117, and the driving element 133 can slide along the operating element 117, so as to drive the control element 131 to slide relative to the cutting element 111, and further, the cutting element 111 can be radially compressed or radially decompressed.
Referring to fig. 3, the retaining assembly 150 includes a retaining claw 151, a mating member 155, a pulling member 157 and an anchor 159 connected together.
The distal end of the retaining claw 151 is connected to the operating member 117, and the projection of the proximal end of the retaining claw 151 is located on the proximal side of the projection of the proximal end of the cutting member 111 in the projection plane parallel to the central axis plane of the operating member 117, that is, the distance between the projection of the proximal end of the retaining claw 151 and the projection of the distal end of the cutting member 111 is larger than the distance between the projections of the proximal end of the cutting member 111 and the distal end of the cutting member 111. And then can guarantee before the electrode of cutting member 111 and interatrial septum tissue, anticreep claw 151 and interatrial septum tissue contact and pierce this tissue for anticreep claw 151 and interatrial septum tissue anchor, and then can play and prevent that interatrial septum tissue from droing.
Specifically, referring to fig. 4, the retaining claw 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 operating 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 the proximal end of the cutting member 111 in a projection plane parallel to a central axis plane of the operating member 117. Such that the proximal end of second portion 154 can penetrate into the septal tissue to ensure that the septal tissue does not fall off of second portion 154 during the cutting process.
The distal end of anticreep claw 151 extends to its near-end, along the extending direction of anticreep claw 151, the camber crescent of first part 153 for the flexibility of first part 153 crescent, when needs are retrieved and are got into and carry sheath pipe 210, can be convenient for radially compress anticreep claw 151, can reduce the resistance that anticreep claw 151 retrieved into the sheath, and then the anticreep claw 151 of being convenient for advances the sheath.
Along the extending direction of anti-disengaging claw 151, the curvature of second part 154 reduces gradually for the flexibility of second part 154 reduces gradually, makes anti-disengaging claw 151 under the circumstances that has sufficient flexibility, can also provide sufficient intensity, avoids the tissue on anti-disengaging claw 151 to receive external force to disturb and take place to drop. And the gradual reduction in curvature of second portion 154 also ensures that the proximal end of second portion 154 maintains an approximately straight configuration, thereby allowing the proximal end of second portion 154 to penetrate the atrial septum tissue. More specifically, the flexibility of the first portion 153 is greater than that of the second portion 154, so that the flexibility provided by the first portion 153 facilitates sheathing the anti-falling claw 151, and the strength provided by the second portion 154 enhances the anti-falling effect of the anti-falling claw 151.
The quantity of anticreep claw 151 is a plurality of, and a plurality of anticreep claws 151 encircle in operating parts 117's periphery and link to each other with it, along anticreep claw 151's distal end to the direction of near-end, arbitrary anticreep claw 151 to operating parts 117's distance crescent for a plurality of anticreep claws 151 form the structure of gathering together gradually by near-end to distal end, and then prevent the atrial septal tissue and drop.
The tangent line passing any point on the anti-falling claw 151 is located outside the anti-falling claw 151, that is, the curve formed by the anti-falling claw 151 is a convex arc. So, when radial compression anticreep claw 151, anticreep claw 151 not only can produce radial compressive deformation, still can be to the near-end extension, and then to the room interval tissue to the near-end propelling movement, the room interval tissue of being convenient for advances the sheath, and the room interval tissue that enters into in carrying sheath pipe 210 will not take place to drop. It should be noted that the fact that the tangent line passing through any point on the retaining claw 151 is located outside the retaining claw 151 means that the retaining claw 151 is located between the tangent line and the operating element 117.
Referring to fig. 3 again, the fitting member 155 of the present embodiment is a tubular structure, the fitting member 155 is sleeved on the periphery of the operation member 117, the fitting member 155 is slidably connected to the anti-separation claw 151, the fitting member 155 is located at the distal side of the anti-separation claw 151, and the fitting member 155 can slide towards the proximal end of the operation member 117 through the traction member 157 to radially compress the anti-separation claw 151, so that the anti-separation claw 151 applies a radial tightening force to the atrial septal tissue, thereby increasing the firmness of the connection between the anti-separation claw 151 and the. And radial compression anticreep claw 151 still can make the anticreep claw 151 that is the convex arc, both can radial compression deformation, can extend to the near-end again, with the atrial septal tissue to the near-end propelling movement sheath.
In this embodiment, the pulling element 157 is a tube structure that is sleeved outside the operating element 117, the pulling element 157 is slidably connected to the operating element 117, and the engaging element 155 is connected to the pulling element 157. The drawing member 157 is provided with a spacing hole 158, and the disengagement preventing claw 151 passes through the spacing hole 158 to be connected to the operating member 117.
Second embodiment
The present embodiment differs from the first embodiment in the structure of the control assembly 330 and the operating member 317.
Specifically, the control assembly 330 is connected to the cutting assembly 310, the control assembly 330 is disposed inside the cutting assembly 310, and the control assembly 330 can be radially expanded to radially expand the cutting assembly 310, so as to change the size of the stoma of the cutting assembly 310, thereby adapting to the requirements of different patients for the size of the stoma.
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 operating member 317 of the cutting assembly 310, the control member 331 is disposed outside the operating member 317, the control member 331 is disposed inside the cutting member 311, and the 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 cell 332. The operating member 317 is provided with an inflation passage 318, the inflation passage 318 is communicated with the cavity sac 332, and the distal end of the operating member 317 is a closed end. An inflation substance (e.g., gas, contrast agent, saline, etc.) may be passed from inflation channel 318 into the bladder cavity 332, thereby causing radial inflation of control member 331.
Third embodiment
The present embodiment also provides an ostomy system comprising the ostomy appliance (ostomy appliance 100 and ostomy appliance 300) described above and a delivery sheath 210.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (10)
1. An ostomy appliance comprising a cutting assembly that is radially self-expandable and a control assembly slidably connected to the cutting assembly, the control assembly radially compressing the cutting assembly by sliding relative to the cutting assembly.
2. An ostomy appliance as claimed in claim 1, wherein the control member includes a control member and a drive member, the control member being connected to the drive member, the cutting member being located outside the drive member, the drive member being adapted to slide the control member relative to the cutting member, the control member being adapted to slide to radially compress the cutting member.
3. An ostomy appliance as claimed in claim 2, characterised in that the distal end of the drive member extends through the cutting assembly in the axial direction thereof, the control member being connected to the drive member at the distal side of the cutting assembly.
4. An ostomy appliance as claimed in claim 1 wherein the cutting assembly comprises a cutting member and an operating member, the cutting member surrounding the outer periphery of the operating member, the distal end of the cutting member being connected to the operating member, the proximal end of the cutting member being radially expandable, the proximal end of the cutting member being of a wavy annular configuration.
5. The ostomy appliance of claim 4, wherein the ostomy appliance further comprises an anti-disengagement assembly, the anti-disengagement assembly comprising an anti-disengagement claw, a distal end of the anti-disengagement claw being connected to the operating member, a proximal end of the anti-disengagement claw extending along a curve towards a proximal side of the operating member, a tangent line passing any point on the anti-disengagement claw being located outside the anti-disengagement claw along a direction from the distal end to the proximal end of the anti-disengagement claw.
6. The ostomy appliance of claim 5, wherein the anti-slip tab 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 on a projected proximal side of the proximal end of the cutting member in a plane of projection parallel to the central axis plane of the operating member.
7. The ostomy appliance of claim 6, wherein the first portion has a gradually increasing curvature and the second portion has a gradually decreasing curvature in a direction extending from the distal end of the anti-disengagement claw to the proximal end thereof.
8. The ostomy appliance of claim 6, wherein the anti-disengagement assembly further comprises a mating member slidably coupled to the anti-disengagement pawl, the mating member being tubular in configuration, the mating member being located on a distal side of the anti-disengagement pawl, the mating member radially compressing the anti-disengagement pawl by sliding the mating member toward the proximal end of the operating member.
9. An ostomy appliance as claimed in claim 8, characterised in that said anti-detachment assembly further comprises an anchoring spike associated with said second portion, said anchoring spike extending in a direction forming an angle θ with the tangent of the distal end of said second portion, 0 ° < θ < 180 °.
10. An ostomy system comprising a delivery sheath and an ostomy appliance as claimed in any of claims 1-9.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911412819.8A CN113116499B (en) | 2019-12-31 | 2019-12-31 | Ostomy appliance and ostomy system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911412819.8A CN113116499B (en) | 2019-12-31 | 2019-12-31 | Ostomy appliance and ostomy system |
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| Publication Number | Publication Date |
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| CN113116499A true CN113116499A (en) | 2021-07-16 |
| CN113116499B CN113116499B (en) | 2023-05-02 |
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| CN201911412819.8A Active CN113116499B (en) | 2019-12-31 | 2019-12-31 | Ostomy appliance and ostomy system |
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| US20040193196A1 (en) * | 2003-03-25 | 2004-09-30 | Angiodynamics, Inc, | Device and method for converting a balloon catheter into a cutting ballon catheter |
| US20080255595A1 (en) * | 2005-03-04 | 2008-10-16 | Dale Buchbinder | Valvulotome |
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| CN113116499B (en) | 2023-05-02 |
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