WO2024255068A1 - 一种用于人体病变组织的清创装置 - Google Patents

一种用于人体病变组织的清创装置 Download PDF

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Publication number
WO2024255068A1
WO2024255068A1 PCT/CN2023/127657 CN2023127657W WO2024255068A1 WO 2024255068 A1 WO2024255068 A1 WO 2024255068A1 CN 2023127657 W CN2023127657 W CN 2023127657W WO 2024255068 A1 WO2024255068 A1 WO 2024255068A1
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WIPO (PCT)
Prior art keywords
rotary cutting
shell
operating handle
cutting head
flushing
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Ceased
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PCT/CN2023/127657
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English (en)
French (fr)
Inventor
虞洪
沈波
俞欣
吕红媛
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Zhejiang University
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Zhejiang University
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Priority to US18/722,497 priority Critical patent/US20260215806A1/en
Publication of WO2024255068A1 publication Critical patent/WO2024255068A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/87—Details of the aspiration tip, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0279—Cannula; Nozzles; Tips; their connection means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0279—Cannula; Nozzles; Tips; their connection means
    • A61M3/0283—Cannula; Nozzles; Tips; their connection means with at least two inner passageways, a first one for irrigating and a second for evacuating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320052—Guides for cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320056—Tunnelers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the present invention relates to the field of medical devices, in particular to the field of interventional medical devices, and specifically to a debridement device for human diseased tissues.
  • Acute pancreatitis is a common disease of the digestive system. Most patients have mild symptoms and are self-limited. However, 15%-25% of AP patients will develop severe acute pancreatitis (SAP), accompanied by necrosis of the pancreas and surrounding tissues and systemic multiple organ failure, with a mortality rate of up to 10%-30%. A large part of the deaths of patients with severe pancreatitis are due to the infection of peripancreatic necrotic material that is difficult to clear during the necrotic infection period. Timely and effective removal of necrotic infection of the pancreas and surrounding tissues is a key factor affecting the efficacy of the treatment.
  • SAP severe acute pancreatitis
  • minimally invasive technology In recent years, with the development of minimally invasive technology, some patients can avoid more damaging laparotomy and choose minimally invasive procedures such as percutaneous catheter drainage (PCD), minimally invasive retroperitoneal pancreatic necrotic tissue removal (MARPN), and laparoscopic assisted drainage to reduce tissue damage and complications.
  • PCD percutaneous catheter drainage
  • MARPN minimally invasive retroperitoneal pancreatic necrotic tissue removal
  • laparoscopic assisted drainage to reduce tissue damage and complications.
  • the minimally invasive treatment plan currently adopted in clinical practice is mainly to locate the abscess cavity through fine needle puncture with the assistance of laparoscopy, initially drain the necrotic fluid through percutaneous puncture and drainage, then open the abscess cavity and use long foreign body forceps and aspirators to remove necrotic tissue and pus.
  • necrotic tissue of acute pancreatitis is fragile and difficult to clamp, and the pus is viscous and easily clogs the suction device, the debridement effect is often poor, and the residual necrotic tissue cannot be completely removed. It is inevitable to perform a second or even multiple operations, which will increase the patient's painful experience, affect the patient's treatment effect, prolong the patient's hospitalization time, and cause a heavy economic burden. At the same time, in the process of clamping and suctioning necrotic tissue, there is a possibility of damaging large blood vessels and causing heavy bleeding. Therefore, there is an urgent need for a safe and efficient surgical instrument for removing necrotic infected tissue in acute pancreatitis.
  • the present invention provides a debridement device for diseased human tissue, which can simultaneously realize rotational excision and suction removal of diseased human tissue, reduce residual necrotic matter, and effectively protect surrounding normal tissue and blood vessels, reduce the possibility of patients needing repeated operations, and improve the efficiency, effect and safety of minimally invasive treatment.
  • the present invention provides a debridement device for human diseased tissue, comprising an insertion tube, a rotary cutting head and An operating handle
  • the insertion tube includes an inner tube and an outer tube sleeved outside the inner tube, a dirt suction chamber is formed in the inner tube, a flushing chamber is formed between the inner tube and the outer tube
  • the rotary cutting head includes a shell and a rotary cutting cutter head arranged in the shell, the interior of the shell is connected to the dirt suction chamber, a rotary cutting opening for exposing the rotary cutting cutter head is formed on the shell, and a notch corresponding to the rotary cutting opening is formed on the outer tube
  • the operating handle is connected to the insertion tube and the rotary cutting head, so as to control the rotary cutting cutter head to cut human tissue at the rotary cutting opening, absorb dirt from the dirt suction chamber, and flush the rotary cutting head through the flushing chamber.
  • the rotary cut is arranged on the side of the shell, and the top of the shell is a blind end and is arc-shaped.
  • a negative pressure suction port is provided on the operating handle, and one end of the dirt suction chamber away from the rotary cutting head is connected to the negative pressure suction port, and the suction bottle and the suction device form negative pressure in the dirt suction chamber through the negative pressure suction port.
  • the rotary cutting cutter head is rotatably arranged in the shell around its own axis.
  • the rotary cutting head includes a rotating shaft, one end of which is connected to the rotary cutting cutter head, and the other end of which is connected to a driving component in the operating handle, and the driving component drives the rotary cutting cutter head to rotate through the rotating shaft.
  • a partition is provided between the inner tube and the outer tube to divide the flushing cavity into a first flushing channel and a second flushing channel, the opening of the first flushing channel away from the end of the operating handle is opened at the end of the rotary cutting head close to the insertion tube, and is located at the position of the rotary cutting opening on the shell, the end of the outer tube away from the operating handle and the shell are not closed, the second flushing channel is formed between the outer tube and the side wall of the shell at the rotary cutting head, and the opening of the second flushing channel is opened at the end of the shell away from the end of the operating handle.
  • the two ends of the outer tube are flush with the upper and lower ends of the shell body where the rotary cut is not provided.
  • a plurality of connecting holes connecting the dirt suction chamber and the flushing chamber are provided on the inner tube, and a flow direction control structure is provided on the connecting holes to allow flushing liquid to enter the dirt suction chamber from the flushing chamber in one direction.
  • a curved portion and a guide wire connected to the curved portion are provided on the insertion tube, and the curved portion is provided at a position of the insertion tube close to the rotary cutting head.
  • the guide wire is connected to the guide wire control structure on the operating handle, and the length of the guide wire is controlled by the operating handle to control the bending degree of the bending portion.
  • the guidewire control structure includes a rotating gear, the guidewire is wound around the rotating gear, and a fixing structure for fixing the rotation angle of the rotating gear is provided on the rotating gear.
  • the debridement device for human diseased tissue when performing debridement of human diseased tissue, can be inserted into the location of the diseased tissue through the laparoscopic surgical opening, and the location of the rotary incision is made to correspond to the diseased tissue, and then the rotary cutting head is controlled by the operating handle to cut the human diseased tissue. While cutting, the rotary incision and the surrounding parts are flushed through the flushing cavity, and the cut diseased tissue and the sewage and other wastes after flushing are sucked out through the suction cavity to complete the debridement of human diseased tissue.
  • the above-mentioned device can simultaneously realize the rotary cutting and suction removal of human diseased tissue, reduce the residual necrotic material, and effectively protect the surrounding normal tissues and blood vessels, reduce the possibility of patients needing repeated operations, and improve the efficiency, effect and safety of minimally invasive treatment.
  • FIG1 is a schematic diagram showing the structure of a device for debridement of human diseased tissue provided by an embodiment of the present invention.
  • FIG. 2 is a schematic structural diagram of the rotary cutting head in FIG. 1 .
  • FIG. 3 is a schematic structural diagram of the shell of the rotary cutting head in FIG. 2 .
  • FIG. 4 is a schematic diagram showing the structure of the rotary cutting head at the rotary cutting head in FIG. 2 .
  • FIG. 5 is a schematic diagram showing the structure of the rotary cutting head and the insertion tube in FIG. 1 after being combined.
  • FIG. 6 is a schematic structural diagram of the first flushing channel in FIG. 5 .
  • FIG. 7 is a schematic structural diagram of the second flushing channel in FIG. 5 .
  • FIG. 8 is a schematic diagram showing the cross-sectional structure of the joint between the operating handle and the insertion tube.
  • the present invention provides a debridement device for diseased human tissue, which can simultaneously realize rotational excision and suction removal of diseased human tissue, reduce residual necrotic matter, and effectively protect surrounding normal tissue and blood vessels, reduce the possibility of patients needing repeated operations, and improve the efficiency, effect and safety of minimally invasive treatment.
  • FIG1 is a schematic diagram of the structure of a debridement device for human diseased tissue provided by an embodiment of the present invention
  • FIG2 is a schematic diagram of the structure of the rotary cutting head in FIG1
  • FIG3 is a schematic diagram of the structure of the shell of the rotary cutting head in FIG2
  • FIG4 is a schematic diagram of the structure of the rotary cutting head of the rotary cutting head in FIG2 (for the convenience of display, part of the shell structure is omitted in FIG4 ).
  • the debridement device for human diseased tissue provided by an embodiment of the present invention includes an insertion tube 10, a rotary cutting head 20, and an operating handle 30.
  • the insertion tube 10 includes an inner tube 11 and an outer tube 12 sleeved outside the inner tube 11, a dirt suction chamber 13 is formed in the inner tube 11, and a flushing chamber 14 is formed between the inner tube 11 and the outer tube 12.
  • the rotary cutting head 20 includes a housing 21 and a rotary cutting head 22 disposed in the housing 21. The interior of the housing 21 is connected to the dirt suction chamber 13 of the inner tube 11. A rotary cutting opening 23 for exposing the rotary cutting head 22 is formed on the housing 21. A notch corresponding to the rotary cutting opening 23 is formed on the outer tube 12 so that the rotary cutting head 22 can directly contact human tissue.
  • the operating handle 30 is connected to the insertion tube 10 and the rotary cutting head 20 to control the rotary cutting head 20 to cut human tissue at the rotary cutting opening 23, suck dirt from the dirt suction chamber 13, and flush the rotary cutting head 20 through the flushing chamber 14.
  • the debridement device for human diseased tissue when debridement of human diseased tissue is performed, can be inserted into the location of the diseased tissue through the laparoscopic surgical opening, and the position of the rotary cut 23 is made to correspond to the diseased tissue, and then the rotary cutter 20 is controlled by the operating handle 30 to cut the human diseased tissue. While cutting, the rotary cut 23 and the surrounding parts are flushed through the flushing cavity 14, and the cut diseased tissue and the sewage and other wastes after flushing are sucked out through the suction cavity 13 to complete the debridement of the human diseased tissue.
  • the above-mentioned device can simultaneously realize the rotary cutting and suction removal of human diseased tissue, reduce the residual necrotic material, and effectively protect the surrounding normal tissue and blood vessels, reduce the possibility of patients needing repeated operations, and improve the efficiency, effect and safety of minimally invasive treatment.
  • the rotary cutting opening 23 is arranged on the side of the housing 21, the end of the housing 21 of the rotary cutting head 20 is a blind end, and the top end thereof is an arc-shaped transition.
  • the blade head 22 can be accommodated in the housing 21 and only contacts the diseased tissue through the rotary cutting opening 23 , which can protect normal tissues and blood vessels during the operation and prevent the rotary cutting blade head 22 from accidentally injuring other parts of human tissue.
  • the rotary cutting opening 23 may be in a chamfered rectangular, circular, elliptical, etc., so as to provide a channel for the necrotic matter to enter the rotary cutting head 20 .
  • a negative pressure suction port 31 is provided on the operating handle 30.
  • the end of the above-mentioned sewage suction chamber 13 away from the rotary cutting head 20 is connected to the negative pressure suction port 31.
  • the suction bottle 41 and the suction device 42 can generate negative pressure in the sewage suction chamber 13 through the negative pressure suction port 31.
  • the sewage suction chamber 13 can directly suck out the cut diseased tissue to prevent the sewage suction chamber 13 from being blocked.
  • the rotary cutting blade 22 is rotatably disposed on the housing 21 around its own axis relative to the housing 21 .
  • the rotary cutting blade 22 may be a double-leaf serrated blade to better cut the diseased tissue.
  • annular groove (not shown) can be provided on the inner wall of the shell 21, and part of the rotary cutter head 22 can be rotatably extended into the groove to complete the fixation of the rotary cutter head 22 and provide guidance for the rotation of the rotary cutter head 22.
  • a connecting assembly 24 is disposed at one end of the shell 21 facing the inner tube 11 .
  • the connecting assembly 24 can be connected to the end of the inner tube 11 by means of threads, so as to facilitate replacement of the rotary cutting head 20 .
  • the rotary cutting head 20 also includes a rotating shaft 25 (see Figure 8), one end of which is connected to the rotary cutting head 22, and the other end is connected to a driving component in the operating handle 30, such as a motor, so that the rotation direction and rotation speed of the rotary cutting head 22 can be controlled through the operating handle 30.
  • a driving component in the operating handle 30, such as a motor such as a motor
  • FIG5 is a schematic diagram of the structure after the rotary cutting head and the insertion tube in FIG1 are combined
  • FIG6 is a schematic diagram of the structure of the first flushing channel in FIG5
  • FIG7 is a schematic diagram of the structure of the second flushing channel in FIG5
  • FIG8 is a schematic diagram of the cross-sectional structure of the joint of the operating handle and the insertion tube.
  • a partition 15 is also provided between the inner tube 11 and the outer tube 12 to divide the flushing cavity 14 into a first flushing channel 141 and a second flushing channel 142.
  • the opening of the first flushing channel 141 away from the end of the operating handle 30 is opened at the end of the rotary cutting head 20 close to the insertion tube 10, and is located at the position of the rotary cutting opening 23 on the shell 21, so as to flush the diseased tissue and pus blocked at the rotary cutting opening 23.
  • the end of the outer tube 12 away from the operating handle 30 is not closed with the shell 21, and the second flushing channel 142 is formed between the side walls of the outer tube 12 and the shell 21 at the rotary cutting head 20, that is, formed at the outer tube 12
  • the opening of the second flushing channel 142 is formed at the end of the housing 21 away from the operating handle 30, between the solid part of the housing 21 without the rotary cut 23, for flushing the diseased tissue and pus in the patient's body.
  • the two ends of the outer tube 12 are flush with the ends of the shell 21 where the rotary cut 23 is not provided, that is, the open ring of the second flushing channel 142 is arranged at the end of the shell 21 where the rotary cut 23 is not provided, so as to facilitate the insertion of the insertion tube 10 and the flushing of the diseased tissue and the surrounding area of the human body.
  • the partition plate 15 is located flush with the end surface of the opening of the rotary cut 23 and extends along the long axis direction of the insertion tube 10 .
  • a flushing interface 32 is provided on the operating handle 30, and the flushing interface 32 is connected to the pump body 43 and is connected to the first flushing channel 141 and the second flushing channel 142. Through the flushing interface 32, the pump body 43 can inject flushing liquid, such as saline, into the first flushing channel 141 and the second flushing channel 142 respectively to flush the rotary cutting head 20.
  • flushing liquid such as saline
  • a plurality of connecting holes 111 are provided on the inner tube 11 of the insertion tube 10 to connect the sewage suction chamber 13 and the flushing chamber 14.
  • a flow control structure such as a one-way valve or a one-way membrane, is provided on the connecting hole 111 to allow flushing liquid to enter the sewage suction chamber 13 from the flushing chamber 14 in one direction to flush the human tissue in the sewage suction chamber 13 and prevent the human tissue from being blocked in the sewage suction chamber 13.
  • the insertion tube 10 may be cylindrical as a whole to facilitate insertion.
  • a bending portion 16 and a guide wire (not shown) connected to the bending portion 16 are also provided on the insertion tube 10.
  • the bending portion 16 can be made of elastic material and is provided on the insertion tube 10 near the position of the rotary cutting head 20.
  • the guide wire can be provided in the flushing cavity 14, or it can be directly buried in the channel inside the outer tube 11, and is connected to the guide wire control structure on the operating handle 30. The length of the guide wire is controlled by the operating handle 30 to control the bending degree of the insertion tube 10.
  • the guide wire control structure may include a rotating gear, on which the guide wire is wound, and a fixing structure for fixing the rotation angle of the rotating gear is also provided on the rotating gear, and the guide wire can be tightened or loosened by the rotating gear to adjust the curvature of the curved portion 16 to adapt to the position of the diseased tissue of the human body.
  • the rotation angle of the rotating gear is locked by the fixing structure to perform the cleaning operation.
  • the fixing structure may be a snap-fit structure, a magnetic structure, etc.
  • a rotation speed adjustment button 351, a flushing water pressure adjustment button 353, and a bending adjustment knob 354 are also provided on the operating handle 30, so as to adjust parameters such as the rotation direction and speed of the rotary cutting head 22 of the debridement device, the negative pressure in the suction chamber 13, the flow rate and pressure of the flushing liquid in the flushing chamber 14, and the bending degree of the insertion tube 10.
  • the insertion tube 10 can be first inserted into the human body, and the degree of bending of the insertion tube 10 can be adjusted so that the diseased tissue contacts the position of the rotary incision 23; then the rotary cutting head 22 is controlled to cut the diseased tissue; at the same time, the cut diseased tissue is sucked out through the suction chamber 13, and the rotary incision 23 and the surrounding human tissue are flushed through the flushing chamber 14. After the debridement is completed, the insertion tube 10 is removed to complete the operation.

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Abstract

一种用于人体病变组织的清创装置，包括插入管、旋切头及操作手柄，插入管包括内管及套设于内管外的外管，在内管内形成有吸污腔，在内管与外管之间形成有冲洗腔，旋切头包括壳体及设置于壳体内的旋切刀头，壳体的内部与吸污腔连通，壳体上形成有用于露出旋切刀头的旋切口，在外管上形成有与旋切口相对应的缺口，操作手柄与插入管及旋切头相连，以用于控制旋切刀头对旋切口处的人体组织进行切割，从吸污腔吸取污物，以及通过冲洗腔对旋切头处进行冲洗。该装置能够同时实现人体病变组织的旋切和吸除，减少坏死物残留，并且有效地保护周围正常组织及血管，降低患者需要反复手术的可能性，提高微创治疗的效率、效果及安全性。

Description

一种用于人体病变组织的清创装置 技术领域
本发明涉及医疗器械领域，尤其涉及介入医疗器械领域，具体为一种用于人体病变组织的清创装置。
背景技术
急性胰腺炎(AP)是消化系统常见的疾病，大部分患者症状较轻，呈自限性，然而15％-25％的AP患者会进展成重症急性胰腺炎(SAP)，伴有胰腺及周围组织坏死和全身多器官功能衰竭，其死亡率高达10％-30％。重症胰腺炎患者的死亡很大一部分是由于坏死感染期难以清除的胰周坏死物伴感染，及时有效的清除胰腺及周围组织坏死感染物是关乎到疗效的关键因素。近年来，随着微创技术的发展，部分病人可以避免损伤较大的开腹手术，而选择经皮穿刺置管引流(PCD)、微创入路腹膜后胰腺坏死组织清除术(MARPN)以及腹腔镜辅助引流等微创术式，减少组织损伤和并发症。目前临床上采取的微创治疗方案，主要是在腹腔镜辅助下，细针穿刺定位脓腔，经皮穿刺引流初步引流坏死液，然后打开脓腔，用长异物钳、吸引器清除坏死组织及脓液。
然而，由于急性胰腺炎坏死组织比较脆弱难以钳取，脓液粘稠易堵塞吸引器，往往清创效果不佳，残留坏死组织不能完全清除，不可避免的要进行二次甚至多次手术，这会增加患者的痛苦体验，影响患者治疗效果，延长患者住院时间，并造成极重的经济负担。同时，钳取吸引坏死组织的过程中，存在损伤大血管引起大出血的可能。因此，临床上亟需一种安全且高效的清除急性胰腺炎坏死感染组织的手术器械。
发明内容
本发明提供了一种用于人体病变组织的清创装置，该装置能够同时实现人体病变组织的旋切和吸除，减少坏死物残留，并且有效地保护周围正常组织及血管，降低患者需要反复手术的可能性，提高微创治疗的效率、效果及安全性。
本发明提供了一种用于人体病变组织的清创装置，包括插入管、旋切头及 操作手柄，所述插入管包括内管及套设于所述内管外的外管，在所述内管内形成有吸污腔，在所述内管与所述外管之间形成有冲洗腔，所述旋切头包括壳体及设置于所述壳体内的旋切刀头，所述壳体的内部与所述吸污腔连通，所述壳体上形成有用于露出所述旋切刀头的旋切口，在所述外管上形成有与所述旋切口相对应的缺口，所述操作手柄与所述插入管及所述旋切头相连，以用于控制所述旋切刀头对所述旋切口处的人体组织进行切割，从所述吸污腔吸取污物，以及通过所述冲洗腔对所述旋切头处进行冲洗。
进一步地，所述旋切口设置于所述壳体的侧面，所述壳体的顶部为盲端，且呈弧形。
进一步地，所述操作手柄上设置有负压吸引口，所述吸污腔远离所述旋切头的一端与所述负压吸引口连通，吸引瓶和吸引器通过所述负压吸引口在所述吸污腔内形成负压。
进一步地，所述旋切刀头可绕自身轴线转动地设置于所述壳体内。
进一步地，所述旋切头包括转轴，所述转轴的一端与所述旋切刀头相连，另一端与所述操作手柄中的驱动部件相连，所述驱动部件通过所述转轴带动所述旋切刀头转动。
进一步地，在所述内管与所述外管之间设置有隔板，以将所述冲洗腔分割成第一冲洗通道及第二冲洗通道，所述第一冲洗通道远离所述操作手柄一端的开口开设于所述旋切头靠近所述插入管的一端，且位于所述壳体上所述旋切口所在的位置，所述外管远离所述操作手柄的一端与所述壳体之间未封闭，所述第二冲洗通道在所述旋切头处形成于所述外管与所述壳体的侧壁之间，所述第二冲洗通道的开口开设于所述壳体远离所述操作手柄一端的端部。
进一步地，所述外管的两个端部与所述壳体上未设置所述旋切口的位置的上下两个端部平齐。
进一步地，在所述内管上设置有多个连通所述吸污腔与所述冲洗腔的连接孔，在所述连接孔上设置有流向控制结构，以允许冲洗液单向从所述冲洗腔进入所述吸污腔内。
进一步地，在所述插入管上设置有弯曲部及与所述弯曲部连接的导丝，所述弯曲部设置于所述插入管靠近所述旋切头所在的位置，所述弯曲部通过所述 导丝与所述操作手柄上的导丝控制结构相连，通过所述操作手柄对所述导丝的长度进行控制，以控制所述弯曲部的弯曲程度。
进一步地，所述导丝控制结构包括旋转齿轮，所述导丝缠绕于所述旋转齿轮上，在所述旋转齿轮上设置有对所述旋转齿轮的旋转角度进行固定的固定结构。
综上所述，在本发明中，在进行人体病变组织清创时，可以将该人体病变组织的清创装置通过腹腔镜手术开孔伸入到病变组织所在位置，并使得旋切口的位置与病变组织相对应，然后通过操作手柄控制旋切头对人体病变组织进行切割，在切割的同时，通过冲洗腔对旋切口及周边部位进行冲洗，通过吸污腔将切割下来的病变组织及冲洗后的污水等污物吸出，以完成人体病变组织的清创。通过上述的装置能够同时实现人体病变组织的旋切和吸除，减少坏死物残留，并且有效地保护周围正常组织及血管，降低患者需要反复手术的可能性，提高微创治疗的效率、效果及安全性。
上述说明仅是本发明技术方案的概述，为了能够更清楚了解本发明的技术手段，而可依照说明书的内容予以实施，并且为了让本发明的上述和其他目的、特征和优点能够更明显易懂，以下特举较佳实施例，并配合附图，详细说明如下。
附图说明
图1所示为本发明实施例提供的用于人体病变组织的清创装置的结构示意图。
图2所示为图1中旋切头的结构示意图。
图3所示为图2中旋切头的壳体的结构示意图。
图4所示为图2中旋切头处的旋切刀头的结构示意图。
图5所示为图1中旋切头与插入管结合后的结构示意图。
图6所示为图5中第一冲洗通道的结构示意图。
图7所示为图5中第二冲洗通道的结构示意图。
图8所示为操作手柄与插入管结合处的截面结构示意图。
具体实施方式
为更进一步阐述本发明为达成预定发明目的所采取的技术手段及功效，以下结合附图及较佳实施例，详细说明如下。
本发明提供了一种用于人体病变组织的清创装置，该装置能够同时实现人体病变组织的旋切和吸除，减少坏死物残留，并且有效地保护周围正常组织及血管，降低患者需要反复手术的可能性，提高微创治疗的效率、效果及安全性。
图1所示为本发明实施例提供的用于人体病变组织的清创装置的结构示意图，图2所示为图1中旋切头的结构示意图，图3所示为图2中旋切头的壳体的结构示意图，图4所示为图2中旋切头的旋切刀头处的结构示意图(为了便于展示，在图4中省却了部分壳体结构)。如图1至图4所示，本发明实施例提供的用于人体病变组织的清创装置包括插入管10、旋切头20及操作手柄30。插入管10包括内管11及套设于内管11外的外管12，在内管11内形成有吸污腔13，在内管11与外管12之间形成有冲洗腔14。旋切头20包括壳体21及设置于壳体21内的旋切刀头22，壳体21的内部与内管11的吸污腔13相连通，在壳体21上形成有用于露出旋切刀头22的旋切口23，在外管12上形成有与旋切口23相对应的缺口，以使旋切刀头22可以直接与人体组织接触。操作手柄30与插入管10及旋切头20相连，以用于控制旋切头20对旋切口23处的人体组织进行切割，从吸污腔13吸取污物，以及通过冲洗腔14对旋切头20处进行冲洗。
在本实施例中，在进行人体病变组织清创时，可以将该人体病变组织的清创装置通过腹腔镜手术开口伸入到病变组织所在位置，并使得旋切口23的位置与病变组织相对应，然后通过操作手柄30控制旋切头20对人体病变组织进行切割，在切割的同时，通过冲洗腔14对旋切口23及周边部位进行冲洗，通过吸污腔13将切割下来的病变组织及冲洗后的污水等污物吸出，以完成人体病变组织的清创。通过上述的装置能够同时实现人体病变组织的旋切和吸除，减少坏死物残留，并且有效地保护周围正常组织及血管，降低患者需要反复手术的可能性，提高微创治疗的效率、效果及安全性。
进一步地，在本实施例中，旋切口23设置于壳体21的侧面，旋切头20的壳体21的端部为盲端，且其顶端呈弧形过渡，通过上述的设置，使得旋切 刀头22能够容纳于壳体21内，仅通过旋切口23与病变组织接触，这能够在术中保护正常组织及血管，且能够避免旋切刀头22误伤其它部位的人体组织。
旋切口23可以呈倒角矩形、圆形、椭圆形等，以用于提供坏死物进入旋切头20内的通道。
在操作手柄30上设置有负压吸引口31，上述的吸污腔13远离旋切头20的一端与负压吸引口31连通，吸引瓶41和吸引器42能够通过负压吸引口31在吸污腔13产生负压，当旋切刀头22将病变组织切割下后，吸污腔13可以直接将切割下的病变组织吸出，以防止吸污腔13发生堵塞。
旋切刀头22可相对于壳体21绕自身轴线转动地设置于壳体21上。
优选地，旋切刀头22可以为双叶锯齿样刀片，以更好地对病变组织进行切割。
进一步地，在本实施例中，为了使得旋切刀头22可旋转地设置于壳体21上，在壳体21的内侧壁上，可以设置环形的凹槽(图未示出)，部分旋切刀头22可转动地伸入凹槽内，以完成旋切刀头22的固定，以及为旋切刀头22的旋转提供引导。
在壳体21朝向内管11的一端设置有连接组件24，连接组件24可以通过螺纹的方式与内管11的端部相连，以便于对旋切头20进行更换。
该旋切头20还包括转轴25(见图8)，该转轴25的一端与旋切刀头22相连，另一端与操作手柄30内的驱动部件，如电机相连，以通过操作手柄30对旋切刀头22的旋转方向及旋转速度进行控制。
图5所示为图1中旋切头与插入管结合后的结构示意图，图6所示为图5中第一冲洗通道的结构示意图，图7所示为图5中第二冲洗通道的结构示意图，图8所示为操作手柄与插入管结合处的截面结构示意图。请继续参照图1、图5至图8，在本实施例中，在内管11与外管12之间还设置有隔板15，以将冲洗腔14分割成第一冲洗通道141及第二冲洗通道142，第一冲洗通道141远离操作手柄30一端的开口开设于旋切头20靠近插入管10的一端，且位于壳体21上旋切口23所在位置，以对堵塞于旋切口23处的病变组织及脓液进行冲洗。外管12远离操作手柄30的一端与壳体21之间未封闭，第二冲洗通道142在旋切头20处形成于外管12与壳体21的侧壁之间，也即形成于外管12 与壳体21未开设旋切口23的实体部分之间，第二冲洗通道142的开口开设于壳体21远离操作手柄30一端的端部，以用于冲洗患者体内的病变组织及脓液。通过两个冲洗通道的设置，能够为不同的区域提供不同流量及压力的冲洗液。
进一步地，外管12的两个端部与壳体21上非旋切口23的位置的端部平齐，也即第二冲洗通道142的开口环设于壳体21的端部未设置有旋切口23的位置，以便于插入管10的插入，以及对人体病变组织及周边的冲洗。
进一步地，在插入管10的长轴方向上，隔板15所在的位置与旋切口23的开口处的端面平齐，且沿插入管10的长轴方向延伸。
在操作手柄30上设置有冲洗接口32，冲洗接口32连通于泵体43与第一冲洗通道141及第二冲洗通道142相连，通过冲洗接口32，泵体43可以将冲洗液，如生理盐水，分别注入到第一冲洗通道141及第二冲洗通道142内，以对旋切头20处进行冲洗。
进一步地，在插入管10的内管11上设置有多个连通吸污腔13与冲洗腔14的连接孔111，在连接孔111上设置有流向控制结构，如单向阀或单向膜，以允许冲洗液单向从冲洗腔14进入吸污腔13内，对吸污腔13内的人体组织进行冲洗，防止人体组织堵塞于吸污腔13内。
进一步地，在本实施例中，插入管10整体可以呈圆柱形，以便于进行插入。
进一步地，在插入管10上还设置有弯曲部16及与弯曲部16连接的导丝(图未示出)，弯曲部16可以由弹性材料制成，设置于插入管10上靠近旋切头20所在的位置，导丝可以设置于冲洗腔14内，也可以直接埋设于外管11内部的孔道内，并与操作手柄30上的导丝控制结构相连，通过操作手柄30，对导丝的长度进行控制，以控制插入管10的弯曲程度。
进一步地，导丝控制结构可以包括旋转齿轮，导丝缠绕于旋转齿轮上，在旋转齿轮上还设置有对旋转齿轮的旋转角度进行固定的固定结构，通过旋转齿轮可以收紧或放开导丝，以调整弯曲部16的弯曲程度，以对人体病变组织的位置进行适应。当将旋切头20调整到合适的位置时，通过固定结构锁定旋转齿轮的旋转角度，以进行清创作业。
可选地，固定结构可以为卡扣结构、磁吸结构等。
请继续参照图1，在操作手柄30上还设置有旋转速度调节按钮351、冲洗水压调节按钮353，以及弯曲调节旋钮354等，以便于对该清创装置的旋切刀头22的旋转方向及转速、吸污腔13内的负压、冲洗腔14内冲洗液的流量及压强、插入管10的弯曲程度等参数进行调节。
在通过本发明提供的人体病变组织清创装置进行病变组织的清创手术时，可以先将插入管10伸入人体内，并通过调控插入管10的弯曲程度，以使得病变组织与旋切口23所在位置接触；然后控制旋切刀头22对病变组织进行切割；与此同时，通过吸污腔13将切割下的病变组织吸出，并通过冲洗腔14对旋切口23及其周边的人体组织部进行冲洗，在完成清创后，去除插入管10，以完成手术。
以上所述，仅是本发明的较佳实施例而已，并非对本发明作任何形式上的限制，虽然本发明已以较佳实施例揭露如上，然而并非用以限定本发明，任何熟悉本专业的技术人员，在不脱离本发明技术方案范围内，当可利用上述揭示的技术内容作出些许更动或修饰为等同变化的等效实施例，但凡是未脱离本发明技术方案内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与修饰，均仍属于本发明技术方案的范围内。

Claims (10)

  1. 一种用于人体病变组织的清创装置，其特征在于：包括插入管、旋切头及操作手柄，所述插入管包括内管及套设于所述内管外的外管，在所述内管内形成有吸污腔，在所述内管与所述外管之间形成有冲洗腔，所述旋切头包括壳体及设置于所述壳体内的旋切刀头，所述壳体的内部与所述吸污腔连通，所述壳体上形成有用于露出所述旋切刀头的旋切口，在所述外管上形成有与所述旋切口相对应的缺口，所述操作手柄与所述插入管及所述旋切头相连，以用于控制所述旋切刀头对所述旋切口处的人体组织进行切割，从所述吸污腔吸取污物，以及通过所述冲洗腔对所述旋切头处进行冲洗。
  2. 根据权利要求1所述的用于人体病变组织的清创装置，其特征在于：所述旋切口设置于所述壳体的侧面，所述壳体的顶部为盲端，且呈弧形。
  3. 根据权利要求1所述的用于人体病变组织的清创装置，其特征在于：所述操作手柄上设置有负压吸引口，所述吸污腔远离所述旋切头的一端与所述负压吸引口连通，吸引瓶和吸引器通过所述负压吸引口在所述吸污腔内形成负压。
  4. 根据权利要求1所述的用于人体病变组织的清创装置，其特征在于：所述旋切刀头可绕自身轴线转动地设置于所述壳体内。
  5. 根据权利要求4所述的用于人体病变组织的清创装置，其特征在于：所述旋切头包括转轴，所述转轴的一端与所述旋切刀头相连，另一端与所述操作手柄中的驱动部件相连，所述驱动部件通过所述转轴带动所述旋切刀头转动。
  6. 根据权利要求1所述的用于人体病变组织的清创装置，其特征在于：在所述内管与所述外管之间设置有隔板，以将所述冲洗腔分割成第一冲洗通道及第二冲洗通道，所述第一冲洗通道远离所述操作手柄一端的开口开设于所述旋切头靠近所述插入管的一端，且位于所述壳体上所述旋切口所在的位置，所述外管远离所述操作手柄的一端与所述壳体之间未封闭，所述第二冲洗通道在所述旋切头处形成于所述外管与所述壳体的侧壁之间，所述第二冲洗通道的开口开设于所述壳体远离所述操作手柄一端的端部。
  7. 根据权利要求6所述的用于人体病变组织的清创装置，其特征在于：所述外管的两个端部与所述壳体上未设置所述旋切口的位置的端部平齐。
  8. 根据权利要求6所述的用于人体病变组织的清创装置，其特征在于：在所述内管上设置有多个连通所述吸污腔与所述冲洗腔的连接孔，在所述连接孔上设置有流向控制结构，以允许冲洗液单向从所述冲洗腔进入所述吸污腔内。
  9. 根据权利要求1所述的用于人体病变组织的清创装置，其特征在于：在所述插入管上设置有弯曲部及与所述弯曲部连接的导丝，所述弯曲部设置于所述插入管靠近所述旋切头所在的位置，所述弯曲部通过所述导丝与所述操作手柄上的导丝控制结构相连，通过所述操作手柄对所述导丝的长度进行控制，以控制所述弯曲部的弯曲程度。
  10. 根据权利要求9所述的用于人体病变组织的清创装置，其特征在于：所述导丝控制结构包括旋转齿轮，所述导丝缠绕于所述旋转齿轮上，在所述旋转齿轮上设置有对所述旋转齿轮的旋转角度进行固定的固定结构。
PCT/CN2023/127657 2023-06-13 2023-10-30 一种用于人体病变组织的清创装置 Ceased WO2024255068A1 (zh)

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