CN216439299U - Biliary tract hose freezing probe apparatus with guide sheath device - Google Patents

Abstract

The utility model relates to a biliary tract hose freezing probe instrument with a guide sheath device, which comprises a freezing probe component and a matched guide sheath; the guide sheath comprises a guide sheath tube and a matched sheath core; the sheath core passes through the guide wire. The freezing probe assembly comprises a probe seat assembly, a connecting pipe and a cold head; the guiding sheath tube passes through the connecting tube and exposes the cold head. The guide sheath comprises a probe guide sheath tube and a guide sheath core arranged in the probe guide sheath tube; the guiding sheath tube comprises a sheath tube seat in a Y-shaped connector form and a sheath tube body of which the left end is connected with the right end of the sheath tube seat of the Y-shaped connector; the side cavity of the Y-shaped connector sheath tube seat forms an angle of 30 degrees with the main cavity, is also communicated with the sheath tube body and is used for injecting contrast medium to facilitate biliary tract development; the utility model has reasonable design, compact structure and convenient use, and can insert the sheath core and the cold head or the connecting pipe of the hose freezing probe into the cavity of the sheath tube body.

Description

Biliary tract hose freezing probe apparatus with guide sheath device

Technical Field

The utility model relates to the field of medical instruments for endoscope or interventional therapy, in particular to a biliary tract hose freezing probe instrument with a guide sheath device.

Background

The cryoablation operation system is a medical equipment for minimally invasive cryoablation of tumor, mainly composed of a freezing main machine, a freezing probe (freezer), a high-pressure air source and corresponding auxiliary structures, and has multiple treatment effects of cryoablation, interventional thermotherapy, immunity enhancement and the like. The method emphasizes minimally invasive, targeted and complete tumor destruction, can accurately position and destroy cancer tissues and protect normal tissues to the maximum extent, provides an effective treatment method for quickly killing tumors and eliminating tumor loads, is particularly applicable to restenosis patients caused by tumor or intimal hyperplasia after biliary stent implantation, and makes up the key clinical problem of postoperative complications caused by stent deformation or fusion due to high temperature in the conventional biliary tract thermal ablation.

The existing cryoablation probe adopts a hollow stainless steel needle metal cryoprobe which extends into tissues, the probe is usually a metal straight head and directly penetrates through the body surface to enter pathological changes for cryotherapy. However, a lumen channel that is curved in a human body through the biliary tract or the like is not suitable. For example, the patent number CN201610874753.4 discloses a flexible tube cryoprobe with a guide wire guiding device and its usage method of beijing kuku blue medical equipment ltd.

2. The temperature can not be measured in real time in the process of cryoablation treatment, and the side damage is caused by excessive freezing of the phenanthrene lumen organ of the biliary tract; meanwhile, the rewarming time cannot be strictly controlled, the secondary cryoablation is started when the temperature is frozen to 0 ℃, the tumor necrosis is facilitated, and the cryotherapy effect can be influenced when the rewarming temperature is too high or too low. Such as a disposable sterile flexible tube cryoprobe of beijing kulan medical devices ltd, with patent number CN 201520149868.8.

3. The freezing probe is difficult to reach the lesion part due to the obstruction of tumor and/or lesion tissue in the biliary tract, the operation is very laborious, and the X-ray radiation in the endoscope and the interventional operation causes excessive radiation harm to the body of the operator and the patient.

In order to solve the above problems, CN201110091860.7, developed and continuously improved by beijing kukukulan medical equipment limited, has patent number CN201110091860.7, a disposable sterile flexible tube cryoprobe, patent number CN201520149868.8, a flexible tube cryoprobe with a guide wire guiding device, and a using method thereof, and has patent number CN 201610874753.4. However, in order to provide the effects of solving the above problems and providing the product performance, the patentee provides a new set of solution based on the advantages and disadvantages of the prior art.

SUMMERY OF THE UTILITY MODEL

The utility model aims to solve the technical problem of providing a biliary tract hose freezing probe instrument with a guide sheath device, which has reasonable design, compact structure and convenient use.

In order to solve the problems, the technical scheme adopted by the utility model is as follows:

a biliary tract hose freezing probe apparatus with a guide sheath device comprises a freezing probe component and a matched guide sheath;

the guide sheath comprises a guide sheath tube and a matched sheath core; the sheath core passes through the guide wire.

As a further improvement of the above technical solution:

the freezing probe assembly comprises a probe seat assembly, a connecting pipe and a cold head; the guiding sheath tube passes through the connecting tube and exposes the cold head.

The guide sheath comprises a probe guide sheath tube and a guide sheath core arranged in the probe guide sheath tube;

the guiding sheath tube comprises a sheath tube seat in a Y-shaped connector form and a sheath tube body of which the left end is connected with the right end of the sheath tube seat of the Y-shaped connector; the side cavity of the Y-shaped connector sheath tube seat forms an angle of 30 degrees with the main cavity, is also communicated with the sheath tube body and is used for injecting contrast medium to facilitate biliary tract development; the cold head or the connecting pipe of the sheath core and the hose freezing probe can be inserted into the cavity of the sheath tube body.

The sheath core comprises a straight-head sheath core seat and a sheath core body arranged on the right side of the straight-head sheath core seat; the sheath core cavity is internally provided with a hydrophilic guide wire, and the inner side and the outer side of the guide sheath tube and the sheath core cavity are respectively attached with a hydrophilic coating.

A biliary tract hose freezing probe apparatus with a guide sheath device comprises a freezing probe component and a matched guide sheath; wherein the cryoprobe assembly comprises a cold head; the guide sheath comprises a guide sheath tube and a matched sheath core;

the guiding sheath tube comprises a sheath tube seat in a Y-shaped connector form and a sheath tube body of which the left end is connected with the right end of the sheath tube seat of the Y-shaped connector; an external connection part is arranged at the left end part of a main cavity of the Y-shaped connector sheath tube seat, an embedded support sleeve with a small left part and a large right part is arranged in an inner cavity of the external connection part, an axial sliding sleeve is movably arranged at the left port of the external connection part, an embedded spring is arranged between the axial sliding sleeve and the embedded support sleeve, and the embedded spring is used for pushing the axial sliding sleeve to the left and the outside; the inner hole of the axial sliding sleeve is circumferentially provided with swinging fan-shaped sheets in an array manner, the swinging fan-shaped sheets are separated from the left end of the embedded support sleeve under the action of the embedded spring when the axial sliding sleeve is in a natural closing state; when the axial sliding sleeve moves rightwards against the acting force of the embedded spring, the swinging fan-shaped sheet is contacted with the left end of the embedded supporting sleeve to open the left port of the external connection part, so that the freezing probe assembly or the sheath core passes through and is clamped by the swinging fan-shaped sheet in an embracing way.

The utility model adopts the technical scheme to produce the beneficial effects that: compared with the radio frequency catheter heat ablation technology, the application has the advantages of repeated treatment, no pain to patients, low cost, less complications and the same treatment effect; meanwhile, the utility model is provided with a freeze ablation integrated solution, the provided materials are complete, other special auxiliary materials are not needed, the operation flow is simplified, and the operation is simple.

The utility model has the advantages of reasonable design, low cost, firmness, durability, safety, reliability, simple operation, time and labor saving, capital saving, compact structure and convenient use. The connecting pipe material adopts the characteristic of a thin-wall polytetrafluoroethylene pipe with a memory metal liner pipe sleeved at the end; the cold head is made of 316L medical stainless steel, is internally provided with an air inlet channel, an air return pipe and a temperature measuring metal coil, and has the characteristics of ultralow temperature freezing, timely temperature measurement and the like; the guide sheath is made of supporting polyamide material and is attached with a hydrophilic coating, has the characteristics of no deformation and no bending in the cavity in vivo, can freely pass through the freezing probe and has the protection effect on the liver and biliary tract tissues. The utility model relates to a biliary tract cryoablation technology, can provide a solution to the clinical key problem of biliary tract malignant tumor stenosis or biliary tract stent postoperative restenosis, and has the advantages of repeated treatment, no pain for patients, low cost, few complications and the like; meanwhile, the utility model is provided with a freeze ablation integrated solution, the operation process is simple and the operation is simple.

Drawings

Fig. 1 is a schematic view of the overall structure of the present invention.

Figure 2 is a schematic diagram of the hose cryoprobe of the present invention.

Fig. 3 is a schematic diagram of the structure of the cold head of the present invention.

Fig. 4 is a schematic view of the structure of the introducer sheath of the present invention.

Fig. 5 is a schematic structural view of the sheath tube seat of the present invention.

Wherein: 1. A probe base assembly; 2. a connecting pipe; 3. cooling the head; 4. an air inlet channel; 5. a choke; 6. a return air duct; 7. a temperature measuring coil; 8. a cryoprobe assembly; 9. a memory metal liner; 10. a polytetrafluoroethylene tube; 11. a temperature measuring conducting wire; 12. an introducer sheath; 13. a sheath tube; 14. a sheath core; 15. a sheath seat; 16. a sheath body; 17. a sheath-core mount; 18. a sheath core body; 19. a guide wire; 20. a lateral cavity; 28. an external connection part; 29. a supporting sleeve is embedded; 30. a spring is embedded; 31. an axial sliding sleeve; 32. the fan-shaped piece is swung.

Detailed Description

Referring to fig. 1-4, a flexible tube cryoprobe with an introducer sheath device of the present invention comprises a cryoprobe assembly 8 and a mating introducer sheath 12; the freezing probe component 8 comprises a probe seat assembly 1, a connecting pipe 2 made of polytetrafluoroethylene and extending into the liver of a human body, and a cold head 3; the guiding sheath pipe 13 passes through the connecting pipe 2 and exposes the cold head 3; the guide sheath 12 can block the tumor and/or block the pathological change tissue to reach the pathological change part through the biliary tract and the biliary tract of the human body; the guide sheath 12 comprises a guide sheath tube 13 and a matched sheath core 14; sheath core 14 can be threaded over 0.035 "guidewire 19;

the freezing probe component 8 has an outer diameter of 8Fr-2.64mm and a length of 50 cm.

An outlet of an air inlet channel 4 is arranged in the cold head 3; a choke 5 is arranged at the head end of the air inlet passage 4, the choke 5 is connected with an air return passage 6, the air return passage 6 is sleeved on the air inlet passage 4, and a metal temperature measuring coil 7 is arranged at the right end part of the air return passage 6; the left rear end part of the cold head 3 is directly inserted into the right port of the connecting pipe 2 and is connected in a sealing way; the right front end of the cold head 3 is welded and then sealed; the left end of the connecting pipe 2 is connected with the probe seat assembly 1, and the probe seat assembly 1 is used for connecting the freezing host machine and the high-pressure air source.

The connecting pipe 2 comprises a super-elastic thin-wall polytetrafluoroethylene pipe 10, the right end of the polytetrafluoroethylene pipe 10 is sleeved with a thin-wall memory metal liner pipe 9, the polytetrafluoroethylene pipe 10 replaces a traditional metal material hard pipe, the flexibility of the elastic non-metal hose can be randomly bent in a body, the flexible memory metal liner pipe can be bent along with a human organ channel, and the memory metal liner pipe 9 has certain strength and can bear large pushing force and bear the radial pressure in the biliary tract. The polytetrafluoroethylene outer tube 10 is communicated with the air return passage 6, the cold head 3 is exposed from the right end of the polytetrafluoroethylene outer tube 10 and is tightly connected, and the memory metal liner tube 9 is connected with the air inlet passage 4 in the cold head in a welding manner, so that the connection reliability is ensured.

The super-elastic thin-wall tube hose and the memory metal thin-wall metal liner tube can be used for thinning the tube wall, reducing the outer diameter of the connecting tube and keeping enough space in the tube, and under the premise of the same refrigeration power, the outer diameter of the probe can be thinner, so that the probe can enter the tiny space of a human body to expand the treatment range. On the premise of the same outer diameter, the refrigeration power can be effectively improved, and the treatment efficiency is improved.

The outer diameters of the connecting pipe 2 and the cold head 3 are the same and are both between 1.8 and 2.4mm, and the length of the cold head 3 is between 10 and 20mm, so that the cold head can be ensured to be capable of freely bending in a body through an endoscope and a percutaneous transhepatic puncture pipeline working channel; the cold head is made of 316L medical stainless steel, and the connecting pipe material is soft polytetrafluoroethylene.

In order to solve the temperature measurement problem, a temperature measurement coil 7 is arranged on the inner side of the cold head 3, the temperature measurement coil 7 is positioned in a refrigerant return air channel 6 outside a throttling port 5 in the cold head 3, a temperature measurement lead 11 is led out of the temperature measurement coil 7, and the temperature measurement lead 11 at the far end of the temperature measurement coil is welded and connected with the probe seat assembly 1 through a polytetrafluoroethylene tube 10; the temperature measuring coil 7 can rapidly detect the real-time temperature of the cold head in the refrigeration process.

The temperature range of the cold head 3 is-40 ℃ to-60 ℃; not only can the tumor cells be killed and the cellular immune reaction be stimulated, but also the biliary tract and surrounding tissues are prevented from necrosis and hemorrhage caused by contrast iatrogenic injury with over-low freezing temperature and over-large freezing range.

In order to solve the problem of difficult operation, the body is protected.

The device is provided with a guide sheath 12 which is a single-cavity coaxial catheter with a side hole, the outer diameter of the guide sheath 12 is 8Fr-2.64mm, the length of the guide sheath is 40cm, and the guide sheath 12 comprises a probe guide sheath pipe 13 and a guide sheath core 14 arranged in the probe guide sheath pipe 13. The introducer sheath 12 is made of a supportive polyamide material and has a degree of bending characteristics.

The guiding sheath 13 comprises a sheath seat 15 in the form of a Y-shaped connector and a sheath body 16 with the left end connected with the right end of the Y-shaped connector sheath seat 15; the main cavity of the Y-shaped connector sheath tube seat 15 is the continuation of the sheath tube body, and the side cavity 20 of the Y-shaped connector sheath tube seat 15 forms an angle of 30 degrees with the main cavity, is also communicated with the sheath tube body 16 and is used for injecting contrast medium to facilitate biliary tract development; the inner diameter of the 16 cavities of the sheath tube body is 7Fr-2.39mm, and a sheath core 14, a cold head 3 of a hose freezing probe and a connecting tube 2 which are sleeved layer by layer are inserted.

The sheath core 14 comprises a straight sheath core seat 17 and a sheath core body 18 arranged on the right side of the straight sheath core seat 17; the inner diameter of the cavity of the sheath core 14 is 0.97mm, a hydrophilic guide wire 19 of 0.035' is adapted, and hydrophilic coatings are attached to the inner and outer sides of the guide sheath tube 13 and the sheath core 14.

Firstly, a guide wire 19 is preset in an intrahepatic bile duct to establish an endoscope or interventional biliary tract treatment working channel, the guide wire 19 is coaxially penetrated into the inner cavity of the sheath core 14, the guide wire 19 is selected to enter a range far away from biliary tract lesion, the guide sheath 12 is continuously arranged to cross the lesion, tumor or lesion injury or bleeding caused by cutting and friction of the lesion can be prevented, the guide sheath core 18 and the guide wire 19 are withdrawn, and the implantation freezing probe assembly 8 is protected by the guide sheath tube 13.

The guiding sheath 13 is arranged telescopically corresponding to the freezing probe assembly 8.

The use method of the biliary tract hose freezing probe instrument with the guide sheath device is characterized in that the device is used; comprises and executes the following steps in sequence:

step a: the guide sheath 12 is inserted into the biliary tract lesion along the guide wire 19, the head of the guide sheath 13 of the guide sheath 12 crosses over the lesion tissue, and the guide wire 19 and the sheath core 14 are withdrawn;

step b: inserting the freezing probe assembly 8 into the guiding sheath 13, and placing the cold head 3 into the lesion;

step c: the guide sheath 12 is retracted to a position 2-3cm away from the cold head 3, the cold head 3 is exposed to the lesion, and the position of the cold head is confirmed to be consistent with that of the lesion tissue again through contrast of a side hole contrast agent of the guide sheath tube 13;

step d: performing cryoablation operation.

As a specific application, the first biliary tract hose cryoprobe instrument with the guide sheath device is applied to the case of stenosis after biliary stent surgery, and is an application example under interventional operation X-ray. Inserting a guide sheath tube containing a sheath core into the biliary tract lesion along a hydrophilic guide wire of 0.035' which is pre-punctured into the biliary tract, wherein the head of the sheath tube of the guide sheath crosses over lesion tissues and exits the guide wire and the sheath core; inserting the hose freezing probe into the sheath, and placing the cold head into the narrow lesion part of the biliary tract stent; and (3) retracting the guide sheath to a position 2-3cm away from the freezing probe, exposing the freezing probe to the lesion, carrying out freezing operation after confirming the position of the cold head is consistent with that of the lesion tissue again through contrast of a sheath side hole contrast agent, and completely freezing and ablating.

As further refinements, the embodiment of fig. 5, as well as a separate embodiment,

as an embodiment, it includes a cryoprobe assembly 8 and a matching introducer sheath; wherein the freezing probe assembly 8 comprises a cold head 3; the guiding sheath comprises a guiding sheath tube 13 and a matched sheath core 14; as an improvement thereof,

the guiding sheath 13 comprises a sheath seat 15 in the form of a Y-shaped connector and a sheath body 16 with the left end connected with the right end of the Y-shaped connector sheath seat 15; an external connection part 28 is arranged at the left end part of a main cavity of the Y-shaped connector sheath tube seat 15, an embedded support sleeve 29 which is small in left and large in right is arranged in the inner cavity of the external connection part 28, an axial sliding sleeve 31 is movably arranged at the left end part of the external connection part 28, an embedded spring 30 is arranged between the axial sliding sleeve 31 and the embedded support sleeve 29, and the embedded spring 30 is used for pushing the axial sliding sleeve 31 to the left and the outside; the inner hole of the axial sliding sleeve 31 is circumferentially provided with swinging fan-shaped sheets 32 in an array manner, the swinging fan-shaped sheets 32 are separated from the left end of the embedded support sleeve 29 under the action of the embedded spring 30 of the axial sliding sleeve 31, and the swinging fan-shaped sheets 32 are in a natural closing state; when the axial sliding sleeve 31 moves to the right against the force of the embedded spring 30, the swinging fan 32 contacts the left end of the embedded supporting sleeve 29 to open the left port of the external part 28, so that the freezing probe assembly 8 or the sheath core 14 passes through and is clamped by the swinging fan 32.

Compared with the traditional sheath tube seat 15, the sheath tube seat has a tail part closed structure, starts sealing and protecting functions, is driven to be opened by friction force when penetrating into the probe assembly, and the swinging fan-shaped piece 32 is in contact with the freezing probe assembly 8 or the sheath core 14 through elastic support to play a role in sealing, righting and centering; the contact part of the device and the flesh tissue is in smooth transition.

The present invention has been described in sufficient detail for clarity of disclosure and is not exhaustive of the prior art.

Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; it is obvious as a person skilled in the art to combine several aspects of the utility model. And such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.

Claims (5)

1. The utility model provides a biliary tract hose freezing probe apparatus of area guide sheath device which characterized in that: comprises a freezing probe component (8) and a guide sheath (12) matched with the freezing probe component (8);

the guide sheath (12) comprises a guide sheath tube (13) and a matched sheath core (14); the sheath core (14) passes through the guide wire (19).

2. The biliary hose cryoprobe apparatus with an introducer sheath device of claim 1, wherein: the freezing probe assembly (8) comprises a probe seat assembly (1), a connecting pipe (2) and a cold head (3); the guiding sheath tube (13) passes through the connecting tube (2) and exposes the cold head (3).

3. The biliary hose cryoprobe apparatus with an introducer sheath device of claim 1, wherein: the guide sheath (12) comprises a probing guide sheath tube (13) and a guide sheath core (14) arranged in the probing guide sheath tube (13);

the guiding sheath tube (13) comprises a sheath tube seat (15) in a Y-shaped connector form and a sheath tube body (16) of which the left end is connected with the right end of the Y-shaped connector sheath tube seat (15); a side cavity (20) of a Y-shaped connector sheath tube seat (15) forms an angle of 30 degrees with a main cavity, is also communicated with a sheath tube body (16), and is used for injecting contrast medium to facilitate biliary tract development; the sheath core (14) and the cold head (3) or the connecting pipe (2) of the hose freezing probe can be inserted into the cavity of the sheath tube body (16).

4. The biliary hose cryoprobe apparatus with an introducer sheath device of claim 3, wherein: the sheath core (14) comprises a straight sheath core seat (17) and a sheath core body (18) arranged on the right side of the straight sheath core seat (17); the cavity of the sheath core (14) is matched with a hydrophilic guide wire (19), and hydrophilic coatings are attached to the inner and outer sides of the guide sheath tube (13) and the sheath core (14).

5. The utility model provides a biliary tract hose freezing probe apparatus of area guide sheath device which characterized in that: it comprises a freezing probe component (8) and a matched guide sheath (12); wherein the freezing probe component (8) comprises a cold head (3); the guide sheath (12) comprises a guide sheath tube (13) and a matched sheath core (14);

the guiding sheath tube (13) comprises a sheath tube seat (15) in a Y-shaped connector form and a sheath tube body (16) of which the left end is connected with the right end of the Y-shaped connector sheath tube seat (15); an external connection part (28) is arranged at the left end part of a main cavity of the Y-shaped connector sheath tube seat (15), an embedded support sleeve (29) with a small left part and a large right part is arranged in an inner cavity of the external connection part (28), an axial sliding sleeve (31) is movably arranged at the left end part of the external connection part (28), an embedded spring (30) is arranged between the axial sliding sleeve (31) and the embedded support sleeve (29), and the embedded spring (30) is used for pushing the axial sliding sleeve (31) outwards and leftwards; the inner hole of the axial sliding sleeve (31) is circumferentially provided with swinging fan-shaped sheets (32) in an array manner, the swinging fan-shaped sheets (32) are separated from the left end of the embedded supporting sleeve (29) under the action of the embedded spring (30) of the axial sliding sleeve (31), and the swinging fan-shaped sheets (32) are in a natural closing state; when the axial sliding sleeve (31) moves rightwards against the action force of the embedded spring (30), the swinging fan-shaped piece (32) is contacted with the left end of the embedded supporting sleeve (29) to open the left port of the external connecting part (28), so that the freezing probe assembly (8) or the sheath core (14) passes through and is clamped by the swinging fan-shaped piece (32) in an encircling way.

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