CN215778572U - Cryoablation clamp system - Google Patents

Abstract

The utility model relates to a cryoablation clamp system, comprising: a jaw assembly having two independent ablation surfaces, the jaw assembly including a first clamping element and a second clamping element, an inlet assembly, an exhaust assembly, a vacuum housing assembly, a spring assembly capable of manually adjusting the jaws, and a dynamic arcuate loop; the inlet assembly comprises a delivery extension pipe, and refrigerant is delivered to the first clamping element and the second clamping element of the clamp part through the delivery extension pipe respectively so as to generate two independent ablation surfaces; the dynamic circular arc loop is connected with the upper end of the second clamping element, and absorbs the displacement of the clamping part by changing the curvature radius and the circular arc angle corresponding to the opening width of the clamping part. The system reduces the probability of over-treatment or under-treatment to the maximum extent, simplifies the treatment process and improves the efficiency and the treatment effect.

Description

Cryoablation clamp system

Technical Field

The utility model relates to the technical field of cryoablation medical instruments, in particular to a cryoablation clamp system for freezing and destroying biological tissues.

Background

Cryosurgical treatment systems involve the application of extremely low temperatures to properly freeze the target biological tissue to be treated. Many such systems use a cryoprobe having a single treatment surface of a particular shape and size that is designed to contact a particular portion of tissue without adversely affecting adjacent healthy tissue or organs. Extreme freezing is produced by introducing a refrigerant through a flexible or rigid probe, and then applying the freezing to the target tissue through a heat transfer element that is part of the probe, and confining the freezing to a relatively small location.

For non-linear lesions, flexible elements that conform to the anatomical shape are typically manipulated manually using flexible or semi-flexible probes. This method, while patient-dependent, time-consuming and of inconsistent therapeutic efficacy, is acceptable for certain non-minimally invasive procedures. For minimally invasive surgery, a simplified product is needed due to the lack of space for manually manipulating the flexible heat transfer element. Currently, the existing product on the market is a cryoclip with a single energy or heat transfer surface, the purpose of which is to grip a contoured surface, such as the pulmonary vein, so that cryogenic energy can penetrate from one side of the clip to the other. This design results in over-treatment of tissue on one side of the clip and under-treatment of tissue on the other side of the clip. Therefore, it is not practical to apply a uniform temperature to the profile with this type of single-sided ablation device. For example, chinese patent CN109394330A, published as 2019, 03 and 01, discloses a pair of freezing pliers, which comprises a pliers body, an ablation portion and a temperature measuring portion. The plier body has a first plier section and a second plier section. The ablation part is arranged on the first clamping part, and the temperature measuring part is arranged on the wall surface of the second clamping part close to the first clamping part. Although the temperature measuring unit is added to this structure to control the freezing temperature, the temperature measuring unit is provided in the second jaw, and therefore this temperature measuring unit cannot measure the temperature of the first jaw but can only measure the temperature of the tissue close to the second jaw after the cryoablation treatment. Using this temperature as an indication of the extent of cryoablation, there is still an over-treatment of the tissue on the side of the first jaw. Thus, the current therapeutic effect is not ideal and a more effective therapeutic device is needed to overcome the deficiencies of the existing products on the market.

Disclosure of Invention

It is an object of the present invention to provide an improved cryoablation clamp system for cryo-disrupting biological tissue, which improved product is capable of evenly distributing energy over the treatment surface for addressing the technical problems of over-or under-treatment in the prior art.

In order to realize the purpose of the application, the utility model adopts the technical scheme that:

a cryoablation clamp system comprising: a jaw member having two independent ablation surfaces, the jaw member including a first clamping element and a second clamping element, an inlet assembly, an exhaust assembly, a vacuum housing assembly, a spring assembly, and a dynamic arcuate loop; the inlet assembly comprises a delivery extension pipe, and refrigerant is delivered to the first clamping element and the second clamping element of the clamp part through the delivery extension pipe respectively so as to generate two independent ablation surfaces; the dynamic circular arc loop is connected with the upper end of the second clamping element, and absorbs the displacement of the clamping part by changing the curvature radius and the circular arc angle corresponding to the opening width of the clamping part.

The further technical scheme adopted by the utility model for solving the technical problem is as follows:

in one embodiment, the area where the two independent ablation surfaces are located is a non-insulated area of two clamp branches in the cryoablation clamp system, which is an ablation area.

In a preferred embodiment, the delivery extension tube comprises a plurality of injection holes located within the ablation region inside each of the clamp branches through which refrigerant enters the ablation region.

In one embodiment, the exhaust assembly has at least one exhaust inlet for receiving return fluid.

In a preferred embodiment, the exhaust gas inlet is an open end of a return extension tube and is located within the first clamping member and the second clamping member, respectively.

In a preferred embodiment, the dynamic circle arc circuit comprises a flexible pipe in which a portion of the delivery extension pipe and the return extension pipe are located.

In a preferred embodiment, the return extension pipe is provided in plurality, and a plurality of the return extension pipes are connected to a return pipe, and the return pipe is connected to a discharge connector.

In a preferred embodiment, one end of the dynamic circular arc loop is connected to the upper end of the movable second clamping element, forming a radial loop, and the other end of the dynamic circular arc loop extends into the handle assembly.

In one embodiment, the curvature radius and the arc angle of the dynamic arc loop correspond to the width of an opening (hereinafter referred to as a "jaw") of the clamp part, and the arc radius is reduced and the arc angle is increased along with the increase of the opening width of the jaw; likewise, during closure of the jaws, the radius of the arc increases and the angle of the arc decreases, thereby absorbing displacement of the clamping members.

In a preferred embodiment, the radius of curvature of the dynamic arcuate loop varies in a range between 0.40 inches and 2.5 inches.

In one embodiment, the spring assembly includes a spring that is pre-compressed to provide a clamping force that is continuous throughout the clamp opening and a lever.

In a preferred embodiment, the spring is mechanically connected to the second clamping member, the spring being compressed to provide a clamping force to the second clamping member.

In a preferred embodiment, the spring is compressed to provide a clamping force in the range of 0.3 to 10 pounds, the extremes of which correspond to the clamping force when the jaws are in the closed position and in the maximum fully open position, respectively.

In a preferred embodiment, the jaw width is manually adjustable by a lever in the spring assembly, the jaw width ranging from 0 inches to 2 inches. Preferably, the lever is required to apply an external force through the handle and then compress the spring to expand the jaws, the return force of the spring automatically closes the jaws when the external force applied to the lever is removed, and the jaws of the pliers release to the thickness of the object to be clamped with a clamping force corresponding to the width of the jaws.

In one embodiment, the vacuum housing assembly encloses, in whole or in part, the inlet assembly and the exhaust assembly, the vacuum housing assembly including a vacuum tube mechanically connected to a vacuum connector and a vacuum lumen, the vacuum lumen defined as a space enclosed by a connector seal, a flexible tube, a handle seal, a flexible tube, and a distal seal, one end of the vacuum tube forming a seal with the vacuum connector, a starting position of the vacuum housing assembly being proximal to the ablation region, and an ending position of the vacuum housing assembly being at the sealed connection of the vacuum tube with the vacuum connector.

Compared with the prior art, the cryoablation clamp system provided by the utility model has the beneficial effects that:

1. the present invention provides a dual ablation surface clamp having two ablation surfaces that deliver energy around a contoured surface, evenly distributing the energy, such as by applying complete cryogenic energy around the entire pulmonary vein at a clamped location during a treatment cycle. The application reduces the probability of over-treatment or under-treatment to the maximum extent, simplifies the treatment process and improves the efficiency and the treatment effect.

2. The dynamic arc loop structure provided by the utility model reduces the pulling damage of the ablation catheter in the process of expanding and closing the jaw, improves the utilization rate of the catheter and saves the cost. The surgical risk caused by the pulling and the damage of the ablation catheter can be avoided, and the safety is improved.

Drawings

Fig. 1 shows a schematic view of the overall structure of a cryoablation clamp system.

Fig. 2 shows a cross-sectional schematic view of a cryoablation clamp system with the clamp opening in an intermediate position.

Fig. 3 shows a cross-sectional schematic view of the cryoablation clamp system with the widest clamp opening.

Fig. 4 shows a cross-sectional schematic view of the cryoablation clamp system with the jaws closed.

Wherein: 10. a cryoablation clamp system; 100. an inlet assembly; 101. an inlet connector; 102. a delivery pipe; 104. conveying an extension pipe; 106. an injection hole; 200. an exhaust assembly; 201. an exhaust connector; 202. a return pipe; 204. a return extension tube; 206. an exhaust gas inlet; 300. a vacuum housing assembly; 301. a vacuum connector; 302. a vacuum tube; 303. a connector seal; 304. a handle seal; 306. a flexible tube; 308. a distal seal member; 400. a dynamic circular arc loop; 500. a handle assembly; 501. a handle; 504. an upper seal member; 506. a flexible handle section; 507. stopping and limiting; 508. lower stop limiting; 512. an upper guide rail; 514. a lower guide rail; 516. a hose; 526. a rigid shaft; 535. a guide groove; 555. a connector portion; 600. a spring assembly; 601. a spring; 602. a lever; 700. a clamp member; 701. a first clamping element; 702. a second clamping element.

Detailed Description

The following describes in detail the best mode of carrying out the utility model. This description merely illustrates the general principles of embodiments of the utility model, and the utility model is not limited to this description. The scope of the utility model is most accurately defined by the claims. The utility model is described in detail below by way of example with reference to the accompanying drawings.

The term "proximal" as used herein refers to the end proximal to the operator, and the term "distal" refers to the end distal to the operator.

Referring to fig. 1 and 2, the present embodiment provides a cryoablation clamp system 10 including a clamp member 700 having two separate ablation surfaces, an inlet assembly 100, an exhaust assembly 200, a vacuum housing assembly 300, a handle assembly 500, a spring assembly 600, and a dynamic arcuate circuit 400, the clamp member 700 including a first clamping element 701 and a second clamping element 702; referring to fig. 2, the inlet assembly 100 includes an inlet connector 101 and delivery extension tubes 104, refrigerant is delivered from a refrigerant source through the inlet connector 101 to the first and second clamping elements 701 and 702 of the jaw member 700 through the two delivery extension tubes 104, thereby creating two separate ablation surfaces; the dynamic circular arc circuit 400 is connected to the upper end of the second clamping member 702, and the dynamic circular arc circuit 400 absorbs the displacement of the clamping member 700 by changing the radius of curvature and the circular arc angle corresponding to the opening width of the clamping member 700. In one embodiment, the inlet assembly 100 further comprises a delivery pipe 102, the inlet connector 101 forms a mechanical seal with one end of the delivery pipe 102, the other end of the delivery pipe 102 forms a mechanical seal with the delivery extension pipe 104, and the delivery pipe 102 is divided into two delivery branches, one delivery extension pipe 104 for each delivery branch. In one embodiment, the inlet connector 101 is provided with two refrigerant output ports, and the two delivery extension pipes 104 may be directly connected to the inlet connector 101 to supply the refrigerant to the two branches of the clamp member 700, respectively.

Referring to fig. 2, the delivery extension tube 104 includes a plurality of injection holes 106, the injection holes 106 are located in the ablation region inside each of the clamp branches, and the refrigerant enters the ablation region through the injection holes 106. The dynamic arcuate loop 400 comprises flexible tubes 306, a portion of each of the transport extension tubes 104 being located within the flexible tube 306, both ends of the transport extension tube 104 extending through the flexible tube 306. The flexible tube 306 is located largely (along its length) within the clamp member 700. A portion of the flexible tube 306 extends above the second clamping member 702 forming the dynamic arcuate loop 400 described above and further described below. The handle assembly 500 includes a flexible handle segment 506 with a first (proximal) end of the flexible tube 306 positioned within the flexible handle segment 506 and a second (distal) end of the flexible tube 306 terminating in a distal seal 308, the distal seal 308 being formed between three tubes, the flexible tube 306, the delivery extension tube 104, and the return extension tube 204. The delivery extension tube 104 extends from the delivery tube 102 into the flexible tube 306 to exit the flexible tube 306 where the distal seal 308 terminates within the ablation region of the clamp member 700. At the beginning of the cold cycle, the refrigerant is delivered from the inlet connector 101 to the end of the delivery extension pipe 104 and then flows out through a plurality of injection holes 106 embedded in the delivery extension pipe 104. The injection holes 106 are disposed along the length of the ablation region of the jaw member 700. The inlet assembly 100 has an inlet connector 101 for receiving a refrigerant and then dispensing the refrigerant into the first and second clamping members 701 and 702, respectively, to form two separate ablation planes for ablating biological tissue. The upper seal 504 is mechanically connected to the first and second clamping elements 701, 702, respectively, and forms a seal between the flexible pipe 306 and the first and second clamping elements 701, 702. The upper seal member 504 may also overlap the distal seal member 308 to form a single mechanical seal connection between the flexible tube 306, the delivery extension tube 104, the return extension tube 204, and the second clamping member 702. After exiting the injection holes and cooling the ablation region of clamp assembly 700, the tempering refrigerant is first directed through exhaust inlet 206 and then into exhaust assembly 200.

The refrigerant enters the discharge assembly 200 through discharge inlets 206, and each clamping element has at least one discharge inlet 206. An exhaust inlet 206 is provided in the clamping element, preferably at or near the proximal end of the ablation zone. All return extension tubes 204 extending from both clamping elements are combined and connected to a return line 202, the return line 202 being connected to a discharge connector 201, the refrigerant to be discharged escaping from the cryoablation clamp system at the discharge connector 201. Referring to fig. 2, the exhaust assembly 200 includes at least one exhaust inlet 206 at the first and second clamping elements 701 and 702 for receiving the return fluid. In one embodiment, exhaust inlet 206 is disposed at a distal end of first clamping member 701 and second clamping member 702 of jaw member 700 as shown in FIG. 2, or at a proximal end proximate to jaw member 700. The exhaust inlet 206 is an open end of the return extension pipe 204, a portion of the return extension pipe 204 being disposed within the flexible pipe 306. The flexible tube 306 can also accommodate other components, including but not limited to a thermocouple, the proximal end of which is embedded in the end surface of the ablation region inside the first and second clamping elements 701 and 702, respectively, and the distal end of which is connected to the cryoablation apparatus through a wire. The second end of the return extension tube 204 is mechanically connected to a separate return tube 202 to form a hermetic seal. The second end of the return tube 202 is mechanically connected to the exhaust connector 201 to form a gas tight seal. Once the return refrigerant or return fluid enters the exhaust assembly 200 through the exhaust inlet 206, the return refrigerant is isolated and contained in the exhaust assembly 200 and then discharged to the atmosphere through the exhaust connector 201. The exhaust assembly 200 comprises a plurality of return extension pipes 204, the plurality of return extension pipes 204 being connected to a return pipe 202, said return pipe 202 being connected to an exhaust connector 201.

The vacuum housing assembly 300 fully or partially encloses the inlet assembly 100 and the exhaust assembly 200 to provide thermal isolation from ambient heat. As shown in FIG. 2, the vacuum housing assembly 300 encloses a portion of the inlet assembly 100 and the exhaust assembly 200 to provide a thermal barrier. The vacuum housing assembly 300 includes a vacuum tube 302 mechanically connected to a vacuum connector 301 and a vacuum lumen 333. One end of the vacuum tube 302 forms a seal with the vacuum connector 301. The starting position of the vacuum housing assembly 300 is proximal to the ablation region and the ending position of the vacuum housing assembly 300 is at the sealed connection of the vacuum tube 302 to the vacuum connector 301. The second end of the vacuum tube 302 is in fluid communication with the vacuum lumen 333. Vacuum lumen 333 is defined as the space enclosed by connector seal 303, hose 516, handle seal 304, flexible tube 306, and distal seal 308. A vacuum pump (not shown) is normally connected to the vacuum connector 301 for removing and expelling foreign particles from the vacuum chamber, leaving the vacuum chamber in an ultra-high vacuum environment suitable for thermal insulation.

A dynamic arcuate loop 400 is provided within handle assembly 500, and dynamic arcuate loop 400 changes its radius of curvature and arcuate angle depending on the width of the opening of the jaws of clamping member 700. The dynamic circle arc loop 400 is formed by a portion of the flexible tube 306 located within the handle assembly 500. The dynamic arcuate loop 400 is defined as beginning at the upper seal 504 and ending at the handle seal 304 and is a length of the flexible tube 306 connected to the second clamping element 702. The jaw opening of the clamp member 700 may be created by displacement of the first clamping element 701 or the second clamping element 702. In one embodiment, one end of the dynamic arcuate loop 400 is connected to the upper end of the movable second clamping member 702 forming a radial loop, and the other end of the dynamic arcuate loop 400 extends into the handle assembly 500. The curvature radius and the arc angle of the dynamic arc loop correspond to the opening width of the clamp part, and the arc radius is reduced and the arc angle is increased along with the increase of the opening width of the jaw; likewise, during closure of the jaws, the radius of the arc increases and the angle of the arc decreases, thereby absorbing displacement of the clamping members. The radius of curvature of the dynamic arcuate loop may vary from 0.40 inches to 2.5 inches.

Referring to fig. 2, the spring assembly 600 includes a spring 601 and a lever 602, the spring 601 being pre-compressed within the cryoablation clamp system to provide a clamping force that is continuous throughout the clamp opening. The second clamping member 702 is mechanically connected to the lever 602, and the lever 602 is guided to move up and down by a guide groove 535 provided on the handle 501. One end of spring 601 is fixed against handle 501 and the other end of spring 601 presses against the top of lever 602, which compresses the spring, creating a downward force on second clamping member 702 when the spring is compressed, providing a clamping force to said second clamping member 702. The spring is compressed to provide a clamping force in the range of 0.3 to 10 pounds, the extremes of which correspond to the clamping force when the jaws are in the closed position and in the fully open maximum position, respectively. The thickness of the clamping object and the width of the jaws determine the clamping force that is generated therewith. The jaw width of the clamp member 700, which can range from 0 inches to 2 inches, can be manually adjusted by a lever 602 in the spring assembly 600. In one embodiment, the lever 602 requires an external force to be applied through the handle to compress the spring to expand the jaw opening, and when the external force applied to the lever 602 is removed, the spring 601 will return to close the jaw opening automatically, and when the jaw of the clamping member is released to the thickness of the object to be clamped, the clamping force will be the same as the width of the jaw opening.

Referring to fig. 3, the jaw member 700 of the cryoablation jaw system is in the widest jaw opening position. In this position, the lever 602 is in contact with the upper stop 507. Dynamic radiused circuit 400 absorbs the upward displacement of the gripping elements by decreasing the radius of the radius and increasing the angle of the radius.

Referring to fig. 4, the clamp member 700 of the cryoablation clamp system is in a closed position. In this position, the spring 601 urges the lever 602 against the lower stop limit 508. The radius of the arc of the dynamic arc loop 400 is increased and the angle of the arc is decreased to accommodate the downward movement of the upper clamping member.

Referring to fig. 2, the handle assembly 500 further includes an upper rail 512, a lower rail 514, and a rigid shaft 526, the upper rail 512 connecting the handle 501 to the rigid shaft 526, the rigid shaft 526 being connected to the lower rail 514, the lower rail 514 having a tight clearance opening (light clearance openings) through which the second clamping member 702 moves up and down. Flexible handle segment 506 is attached to handle 501 and is disposed in a spatially perpendicular relationship to rigid shaft 526. The inlet connector 101, the exhaust connector 201, the vacuum connector 301 and the delivery tube 102, the return tube 202 and the vacuum tube 302 to which they are connected, together form a connector portion 555, the connector portion 555 being connected to the proximal end of the flexible handle section 506. The clamp assembly 700 contains two clamping elements, that is, the cryoablation clamp system 10 has two clamp branches to create two separate ablation planes. Having two ablation surfaces can deliver energy around the contoured surface, such as by applying complete cryogenic energy around the entire pulmonary vein at a clamped location during a treatment cycle. The application reduces the probability of over-treatment or under-treatment to the maximum extent, simplifies the treatment process and improves the efficiency and the treatment effect. In one embodiment, the two clamp branches are a first clamping element 701 and a second clamping element 702, the second clamping element 702 being a dynamic element and the first clamping element 701 being a static element. The clamping member is a bent tube having a curvature of from 70 degrees to 145 degrees, preferably 90 degrees. The clamping element has an insulating region and a non-insulating region. The area of the two separate ablation surfaces is an uninsulated region, defined as the length from the distal seal 308 to the distal end where heat transfer occurs. The ablation region of the clamping member may be a circular surface (e.g., the surface of a circular tube), a semi-circular surface, or a flat surface.

The above embodiments describe a configuration of a cryoablation clamp system in which the second clamping member 702 is movable and the first clamping member 701 is fixed. In another embodiment, the opposite state can be designed, wherein the second clamping element is static and the first clamping element is dynamic. For all possible embodiments, the cryoablation clamp system of the present invention comprises at least one inlet assembly that receives a refrigerant and then delivers it to the ablation region through a delivery extension tube and releases the refrigerant to the ablation region through an injection orifice formed in the delivery extension tube; the vent assembly receives return refrigerant or return fluid through return extension tubes that are connected to a return tube that connects to a vent connector and then directs the return refrigerant out of the cryoablator clamp system and out to the atmosphere; a vacuum housing assembly encloses a portion of the inlet assembly and the exhaust assembly, isolating and preventing direct contact with ambient air by providing an ultra-high vacuum environment suitable for thermal insulation; the handle assembly manually controls the clamp opening width through a lever and a spring in the spring assembly, and the handle assembly is provided with a dynamic circular arc loop which changes the curvature radius and the circular arc angle of the dynamic circular arc loop according to the clamp opening width; and a clamping member comprising an ablation region that is thermally transferable.

The above description is of the preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may occur to those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the utility model should be included in the protection scope of the present invention.

Claims (11)

1. A cryoablation clamp system, comprising:

a jaw member having two separate ablation surfaces, said jaw member including a first clamping member and a second clamping member;

an inlet assembly comprising an inlet connector and a delivery extension tube through which refrigerant is delivered from a refrigerant source through two branches into which the delivery extension tube splits, thereby creating two separate ablation surfaces;

an exhaust assembly;

a vacuum housing assembly;

a spring assembly;

the dynamic arc loop is connected with the upper end of the second clamping element;

wherein the dynamic circular arc circuit absorbs displacement of the jaw member by changing a curvature radius and a circular arc angle corresponding to an opening width of the jaw member.

2. The cryoablation clamp system of claim 1, wherein the area of the two separate ablation surfaces is an uninsulated portion of the two clamp branches of the cryoablation clamp system, the uninsulated portion being an ablation region.

3. The cryoablation clamp system of claim 2, wherein the delivery extension tube includes a plurality of injection holes located within the ablation region within each of the clamp branches, refrigerant passing through the injection holes into the ablation region.

4. The cryoablation clamp system of claim 1 wherein the vent assembly has at least one vent inlet for receiving return fluid.

5. The cryoablation clamp system of claim 4, wherein the vent inlet is an open end of a return extension tube and is positioned within the first clamping member and the second clamping member, respectively.

6. The cryoablation clamp system of claim 5, wherein the dynamic arcuate loop comprises a flexible tube, and wherein a portion of the delivery extension tube and the return extension tube are positioned within the flexible tube.

7. The system as claimed in claim 6, wherein there are a plurality of said return extension tubes, each of said plurality of return extension tubes being connected to a return tube, said return tube being connected to a drain connector.

8. The cryoablation clamp system of claim 1, wherein one end of the dynamic arcuate loop is connected to an upper end of the movable second clamping element forming a radial loop, and the other end of the dynamic arcuate loop extends into a handle assembly.

9. The cryoablation clamp system of claim 1, wherein the spring assembly comprises a spring and a lever, the spring being pre-compressed to provide a clamping force that is continuous throughout the clamp opening.

10. The cryoablation clamp system of claim 9, wherein the spring is mechanically coupled to the second clamping member, the spring being compressed to provide a clamping force to the second clamping member.

11. The cryoablation clamp system of claim 1 wherein the vacuum housing assembly encloses, in whole or in part, the inlet assembly and the exhaust assembly, the vacuum housing assembly including a vacuum tube mechanically connected to a vacuum connector, one end of the vacuum tube forming a seal with the vacuum connector, a starting position of the vacuum housing assembly being proximal of the ablation region, and an ending position of the vacuum housing assembly being at the sealed connection of the vacuum tube with the vacuum connector.

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