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CN-116172690-B - Ostomy device and ostomy system

CN116172690BCN 116172690 BCN116172690 BCN 116172690BCN-116172690-B

Abstract

The invention discloses an ostomy device and an ostomy system, wherein the ostomy device comprises a puncture assembly, a cutting assembly and a sheath assembly, the puncture assembly comprises a mandrel and a puncture part, the puncture part is arranged at the distal end of the mandrel, the cutting assembly surrounds the mandrel and is arranged at the proximal end of the puncture part, the sheath assembly surrounds the puncture assembly and the cutting assembly, a containing pipe section is arranged at the distal end of the sheath assembly, and the caliber of a distal opening of the containing pipe section is adjustable. The distal end of the sheath tube component of the ostomy device is provided with a containing tube section, the aperture of the distal end opening of the containing tube section is adjustable, and an external flared horn mouth can be formed at the distal end, so that when the cutting component cuts atrial septum tissue from the distal end to the proximal end, the containing tube section can contain the cut tissue, and the cut tissue is prevented from escaping into blood circulation to cause thrombus.

Inventors

  • TANG CHAO
  • LIU JIANYONG

Assignees

  • 先健科技(深圳)有限公司

Dates

Publication Date
20260512
Application Date
20221229

Claims (11)

  1. 1. An ostomy device, the ostomy device comprising: The puncture assembly comprises a mandrel and a puncture part, and the puncture part is arranged at the distal end of the mandrel; The cutting assembly surrounds the mandrel and is arranged at the proximal end of the puncture part; The sheath tube assembly is arranged around the puncture assembly and the cutting assembly, a containing tube section is arranged at the distal end of the sheath tube assembly, the caliber of a distal opening of the containing tube section is adjustable, and the hardness of the containing tube section is gradually increased from the distal end to the proximal end; And the distal end of the traction piece is connected with the distal end of the containing pipe section.
  2. 2. The ostomy device of claim 1, wherein the cutting assembly comprises a first support mechanism, a first cutting portion and a second support mechanism, a distal end of the first support mechanism being connected to a proximal end of the piercing portion, the first cutting portion being connected between the first support mechanism and the second support mechanism such that the first support mechanism and the second support mechanism cooperate to fold and collapse the first cutting portion to a mandrel or the first support mechanism and the second support mechanism cooperate to distract the first cutting portion.
  3. 3. The ostomy device of claim 2, further comprising a first sleeve having a distal end connected to a proximal end of the second support mechanism, the first sleeve being disposed about the mandrel and the mandrel being axially movable relative to the first sleeve to move the distal end of the first support mechanism relatively closer to or farther from the proximal end of the second support mechanism, such that the first cutting portion is deployed away from the mandrel or is collapsed closer to the mandrel.
  4. 4. The ostomy device of claim 1, wherein the inner wall of the receiving tube section is circumferentially spaced apart with a plurality of anchor tabs, the distal end of the traction member being connected to the distal end of the anchor tabs, the ostomy device further comprising a handle assembly, the proximal end of the traction member extending into the handle assembly.
  5. 5. The ostomy device of claim 4, wherein the receiving tube comprises adjacent first and second tube sections, the second tube section being disposed at a proximal end of the first tube section, the second tube section having a hardness greater than a hardness of the first tube section.
  6. 6. The ostomy device of claim 5, wherein the receiving tube section further comprises a third tube section disposed on a side of the second tube section remote from the first tube section, the third tube section having a hardness greater than a hardness of the second tube section.
  7. 7. The ostomy device of claim 5, wherein the first tube section is resilient in a perpendicular axial direction such that a distal opening caliber of the receiving tube section is adjustable.
  8. 8. The ostomy device of claim 1, wherein the sheath assembly further comprises a tube segment, the receiving tube segment being disposed at a distal end of the tube segment; The sheath tube assembly further comprises a plurality of first perforations and second perforations, wherein the first perforations are arranged at the distal end of the containing tube section and penetrate through the side wall of the containing tube section, the second perforations are arranged at the distal end of the catheter section, the catheter section comprises a first channel, the first channel extends from the second perforations towards the proximal end along the axial direction of the catheter section, the distal end of the traction piece is connected with the distal end of the fixing piece, penetrates through the first perforations to penetrate through the distal end side wall of the containing tube section, extends towards the proximal end along the containing tube section, and enables part of the traction piece to be positioned at the outer side of the containing tube section, extends to the distal end of the catheter section and penetrates into the first channel from the second perforations.
  9. 9. The ostomy device of claim 3, further comprising a handle assembly including a first control member, a second control member, a third control member and a handle housing, the first control member, the second control member and the third control member being disposed on the handle housing and being slidable in an axial direction of the handle housing, the ostomy device further comprising a traction member having a distal end connected to a distal end of the receiving tube section, the first control member being fixedly connected to a proximal end of the spindle, the second control member being fixedly connected to a proximal end of the first sleeve, the third control member being fixedly connected to a proximal end of the traction member, the third control member pulling or releasing the distal end of the receiving tube section in an axial direction to increase or restore a caliber of a distal opening of the receiving tube section.
  10. 10. An ostomy system, the ostomy system comprising: the ostomy device of any one of claims 1-3 or 9; The radiofrequency ablation instrument is electrically connected with the puncture assembly, and the cutting assembly is electrically connected with the radiofrequency ablation instrument.
  11. 11. An ostomy system, the ostomy system comprising: The radio frequency ablation instrument can output bipolar radio frequency power; the ostomy device of any one of claims 5-8, wherein the piercing assembly is electrically connected to the radiofrequency ablation instrument, the cutting assembly is electrically connected to the radiofrequency ablation instrument, and the anchor tab is electrically connected to the radiofrequency ablation instrument.

Description

Ostomy device and ostomy system Technical Field The invention relates to the field of medical instruments, in particular to an ostomy device and an ostomy system. Background This section provides merely background information related to the present disclosure and is not necessarily prior art. Heart failure (abbreviated heart failure) is a complex set of clinical syndromes caused by abnormal changes in cardiac structure and/or function, dysfunction of ventricular contractions and/or expansions, and is mainly manifested by dyspnea, fatigue, fluid retention (pulmonary congestion, systemic congestion, and peripheral edema), etc. According to the left ventricular ejection fraction, heart failure with reduced ejection fraction, heart failure with retained ejection fraction, and heart failure with intermediate ejection fraction are classified. According to the time and speed of heart failure, it is classified into chronic heart failure and acute heart failure. Most patients with acute heart failure are partially relieved after hospitalization, and the patients with chronic heart failure are often hospitalized due to various severe acute exacerbations. The aging of the population of China is aggravated, the incidence of chronic diseases such as coronary heart disease, hypertension, diabetes, obesity and the like is in an ascending trend, and the medical level is improved, so that the life cycle of heart disease patients is prolonged, and the prevalence of heart failure of China is in a continuous ascending trend. Investigation of 10 domestic 714 cases of heart failure patients in hospital shows that the death rates of heart failure patients in 1980, 1990 and 2000 are 15.4%, 12.3% and 6.2% respectively, and the main death causes are left heart failure (59%), arrhythmia (13%) and sudden cardiac death (13%). China HF study showed that the death rate of hospitalized heart failure patients was 4.1%. The clinical features of HFpEF (ejection fraction preserved heart failure) patients are labored dyspnea, and in HFpEF patients there are many mechanisms that can lead to reduced exercise tolerance. HFpEF patients have increased left ventricular relaxation disorders and stiffness, preventing an increase in end-diastole left ventricular volume during exercise, resulting in an increase in Pulmonary Capillary Wedge Pressure (PCWP) and Left Atrial Pressure (LAP), leading to increased pulmonary congestion and poorer prognosis. No drug or device has been available to date to significantly reduce mortality or risk of hospitalization in HFpEF patients. Clinically, by forming an artificial defect (stoma) at the atrial septum, a shunt of the left and right atrial chambers may be formed, shunting the left atrium to the right atrium, thereby reducing the left atrial pressure. After the left atrium pressure is reduced, the pulmonary artery pressure and the pulmonary capillary wedge pressure are reduced, so that the symptoms of dyspnea, fatigue and the like of a patient are relieved. Such stomas are typically formed at the atrial septum using atrial shunt devices, radio frequency ablation stomas, or radio frequency cutting stomas. The atrial shunt instrument is generally implanted into an atrial septum by using a minimally invasive operation to form a shunt opening, the radio frequency ablation stoma is generally slowly eroded to a required aperture at the atrial septum by a radio frequency electrode, and the radio frequency ablation stoma is generally directly cut to the required aperture at the atrial septum by the radio frequency electrode. The use of radio frequency ablation or radio frequency cutting for interatrial ostomy can avoid the risk of thrombus of the implant, greatly reduce the post-anticoagulation time, reduce the postoperative recovery cost of the patient, and in the operation of implanting an atrial shunt instrument, when the atrial shunt instrument needs to be taken out due to thrombus or stoma closure and other problems, the atrial shunt instrument needs to be taken out through chest surgery, which can lead to poor prognosis of the patient and increased treatment cost. While rf ablation, as opposed to rf ablation, can directly cut an aperture of the desired size, making the cut faster and thus reducing the procedure time, the cut forms a larger tissue mass with the risk of entering the ventricle or aorta to cause embolism. Disclosure of Invention Based on the above, the invention provides an ostomy device for solving the technical problem that tissues formed by cutting a stoma are easy to fall into a ventricle or an aorta to cause embolism. The invention adopts the following technical proposal that the ostomy device comprises: The puncture assembly comprises a mandrel and a puncture part, and the puncture part is arranged at the distal end of the mandrel; The cutting assembly surrounds the mandrel and is arranged at the proximal end of the puncture part; The sheath tube assembly is arranged around the puncture assembly