Patent Description:
Endoscopic metal clamp hemostasis is one of the widely used hemostasis means. Proficient metal clamp operation on appropriate cases can effectively stop bleeding and prevent rebleeding, reduce adverse reactions, and greatly improve safety and a cure rate of endoscopic treatment of gastrointestinal bleeding. A hemostatic mechanism of a metal hemostatic clamp is the same as that of surgical vessel ligation or suture. It is a physical and mechanical method. By using mechanical force generated when the hemostatic clamp is closed, surrounding tissues and a bleeding blood vessel are ligated together, thereby closing the bleeding blood vessel to block blood flow to achieve the goal of stop bleeding. It is suitable for hemostasis treatment of non-variceal active bleeding and visible vascular stump lesions.

The existing hemostatic clamp has the defect of being difficult to operate, and the hemostatic clamp cannot be tentatively operated. Once it is closed, it cannot be opened again. If there is an operational error, the hemostatic clamps will be directly discarded. Therefore, it is necessary to provide a hemostatic clamp that can be reopened before clamping the tissue and can be locked after clamping the tissue.

<CIT> discloses a hemostatic clamp with a ball head pull rod and two clamping pieces, which is configured to separate the clamping pieces by pulling the ball head pull rod reaward. However, this hemostatic clamp fails to provide a reliable separation of the pull rod from the two clamping pieces.

<CIT> provides a multiple hemostatic clip application apparatus includes a multiple clip assembly and a flexible sheath coupled with the multiple clip assembly. For the clip coupling, a pull rod structure is pulled to introduce the multiple clip assembly into a fin bending channel in a housing. Fins of the multiple clip assembly are depressed and stowed by the inside of the fin bending channel. The flexible sheath is inserted in an access hole to register the inside of the flexible sheath with the fin bending channel. When the operating wire is pulled relative to the flexible sheath, the multiple clip assembly is introduced into the flexible sheath. In addition, the existing hemostatic clamps mostly use a three-jaw circlip to realize separation between the hemostatic clamp and a control portion, and have the problems of difficulty in separation and the like when in use.

A technical problem to be solved by the present invention is to provide a hemostatic clamp.

In order to achieve the above objective, the present invention adopts the following technical solution:.

Preferably, an inner surface of the plastic sleeve is an inclined conical surface, and an inner diameter of a top of the plastic sleeve is greater than an inner diameter of a bottom of the plastic sleeve.

A size of the inner surface of the plastic sleeve matches a size of an outer surface of the steel sleeve at a portion fitting therewith.

Preferably, the steel sleeve is divided into upper and lower portions. The upper portion is configured to match the plastic sleeve, and the lower portion is configured to connect a spring tube.

Preferably, an outer surface of the upper portion of the steel sleeve forms an interference fit with an inner surface of the plastic sleeve.

Preferably, a plurality of holes is disposed in circumference of the fixed mount, and the plastic sleeve is bonded to the fixed mount by injecting glue into the fixed mount through the holes.

Preferably, a diameter of the ball head is greater than a diameter of the pull rod, and the diameter of the ball head is greater than an inner diameter of the steel sleeve. The diameter of the pull rod is equal to the inner diameter of the steel sleeve.

Preferably, the ball head pull rod also includes a connecting tube, a top of the connecting tube being connected to the pull rod, and a bottom of the connecting tube being configured to be connected to a pull rope.

According to the hemostatic clamp provided by the present invention, the two clamping pieces are opened and closed through the ball head pull rod, and a clamping portion at a front end and a control portion at a rear end are separated through fit of the ball head pull rod with the plastic sleeve and the steel sleeve. Therefore, the hemostatic clamp has the advantages of simple structure, simple operation and high operation stability and is a hemostatic clamp suitable for wide use.

The following further describes the technical solutions of the present disclosure with reference to the accompanying drawings and specific embodiments. In the following description, a clamping portion for clamping a blood vessel is a front end, and a control portion of the hemostatic clamp for a doctor to operate is a rear end.

As shown in <FIG> and <FIG>, the hemostatic clamp provided by the present invention includes two clamping pieces <NUM>, a fixed mount <NUM>, a ball head pull rod <NUM>, a plastic sleeve <NUM> and a steel sleeve <NUM>.

The two clamping pieces <NUM> are disposed at a front end of the fixed mount <NUM> through a fixing pin <NUM>, and the two clamping pieces <NUM> are oppositely disposed. The fixing pin <NUM> respectively passes through sliding slots <NUM> disposed in the middle of the two clamping pieces <NUM> and limits the two clamping pieces <NUM> between two brackets at the front end of the fixed mount <NUM>. The fixing pin <NUM> may slide along the sliding slots <NUM>, and the two clamping pieces <NUM> may rotate around the fixing pin <NUM>. Rear ends of the two clamping pieces <NUM> are respectively provided with a hemispherical shell-shaped connecting portion <NUM> (also referred to as a ball head bowl). The ball head pull rod <NUM> includes a pull rod <NUM> and a ball head <NUM> disposed at a front end of the pull rod <NUM>, and the ball head <NUM> of the ball head pull rod <NUM> is limited to the inside of the two oppositely disposed hemispherical shell-shaped connecting portions <NUM>. The ball head pull rod <NUM> is configured to drive opening and closing of the two clamping pieces <NUM>. As the ball head <NUM> reciprocates in an up-down direction, the rear ends of the two clamping pieces <NUM> are driven to reciprocate in the up-down direction, and at the same time, under the action of the fixing pin <NUM>, the two clamping pieces <NUM> are opened and closed. After the two clamping pieces <NUM> are closed, by continuing pulling the ball head pull rod <NUM> rearward, the two closed clamping pieces <NUM> are stuck at the front end of the fixed mount <NUM>. Then, by continuing pulling the ball head pull rod <NUM> rearward, the ball head <NUM> moves rearward to deform the hemispherical shell-shaped connecting portions <NUM>, and the ball head <NUM> is separated from the hemispherical shell-shaped connecting portions <NUM>.

The fixed mount <NUM> includes a tube body <NUM> and two brackets <NUM> disposed at a front end of the tube body <NUM>. The tube body <NUM> includes a plurality of stepped cavities, and an inner diameter of an upper cavity is less than an inner diameter of a lower cavity. The plastic sleeve <NUM> and the steel sleeve <NUM> are disposed in a region of a lower portion of an inner cavity of the fixed mount <NUM> with the greatest inner diameter (that is, disposed in the bottommost cavity), and the plastic sleeve <NUM> is disposed between the steel sleeve <NUM> and an inner wall of the fixed mount <NUM>. The ball head pull rod <NUM> passes through the steel sleeve <NUM>. After the ball head pull rod <NUM> is separated from the clamping pieces <NUM>, by pulling the ball head pull rod <NUM> rearward, the ball head <NUM> drives the steel sleeve <NUM> to slide out of the plastic sleeve <NUM>.

Specifically, as shown in <FIG>, the clamping piece <NUM> is provided with an inwardly closed jaw <NUM> at the front, a middle connecting body <NUM> at the middle and the hemispherical shell-shaped connecting portion <NUM> at the rear end. Serrations extending in a closing direction are formed at a front end of the jaw <NUM> and configured to realize clamping. The sliding slot <NUM> is formed in the middle connecting body <NUM> of the clamping piece <NUM>. The sliding slot <NUM> includes an inclined portion <NUM> and a bent portion <NUM>. A distance between the inclined portion <NUM> and an outer wall of the clamping piece <NUM> gradually decreases from the rear end to a front end of the clamping piece <NUM>, and the outer wall of the clamping piece <NUM> refers to a side wall facing away from the closing direction of the clamping piece <NUM>. The bent portion <NUM> is disposed at one end of the sliding slot <NUM> away from the hemispherical shell-shaped connecting portion <NUM>, that is, disposed at a position near the front end of the clamping piece <NUM>, and an extending direction of the bent portion <NUM> is parallel to a length direction of the clamping piece <NUM>. When the fixing pin <NUM> slides from the inclined portion <NUM> of the sliding slot <NUM> to a position of the bent portion <NUM>, the two clamping pieces <NUM> are in a closed locking position. The hemispherical shell-shaped connecting portions <NUM> of the two clamping pieces <NUM> have opposite and facing opening directions to limit the ball head <NUM> of the ball head pull rod <NUM> to the inside of the two hemispherical shell-shaped connecting portions <NUM>. A structure of the ball head pull rod <NUM> is shown in <FIG>. The ball head pull rod <NUM> includes the pull rod <NUM> and the ball head <NUM> disposed at the front end of the pull rod <NUM>. A notch is formed in each of the hemispherical shell-shaped connecting portions <NUM> and configured to accommodate the pull rod <NUM> of the ball head pull rod <NUM>. By pulling the ball head pull rod <NUM>, the ball head <NUM> moves rearward to deform the hemispherical shell-shaped connecting portions <NUM>, and the ball head pull rod <NUM> is separated from the hemispherical shell-shaped connecting portions <NUM>.

Besides, an annular protrusion <NUM> is formed on an outer wall of the hemispherical shell-shaped connecting portion <NUM> and configured to fit with an annular flange <NUM> disposed at the front end of the tube body of the fixed mount <NUM>. When the hemispherical shell-shaped connecting portion <NUM> moves rearward to the inside of the fixed mount <NUM>, the protrusion <NUM> is stuck at the rear of the annular flange <NUM> to realize closed locking. In order to facilitate pulling the ball head pull rod <NUM>, the protrusion <NUM> has an inclined transitional surface.

As shown in <FIG> and <FIG>, the fixed mount <NUM> includes the tube body <NUM> and the two brackets <NUM> disposed at the front end of the tube body <NUM>, and the two brackets <NUM> respectively extend upward from two opposite sides of the tube body <NUM> independently. Corresponding positions of upper portions of the two brackets <NUM> are respectively provided with a through hole <NUM>. The fixing pin <NUM> respectively passes through the sliding slots <NUM> disposed in the middle of the two clamping pieces <NUM>, and two ends of the fixing pin are respectively fixed after passing through the through holes <NUM>, thereby limiting the two clamping pieces <NUM> between the two brackets <NUM> at the front end of the fixed mount <NUM>. The clamping pieces <NUM> may be opened and closed in a region between the two brackets <NUM>.

As shown in <FIG> and <FIG>, the plurality of stepped cavities is formed in the tube body <NUM>, and the inner diameter of the upper cavity is less than the inner diameter of the lower cavity. Since the inner diameter of the topmost cavity is less than a distance between the two brackets <NUM>, one annular flange <NUM> is formed at a position where the topmost cavity meets the bracket, and thus, the annular flange <NUM> defines a narrow inlet of the tube body <NUM>. Under the action of the ball head pull rod <NUM>, the hemispherical shell-shaped connecting portions <NUM> of the two clamping pieces <NUM> enter the topmost cavity <NUM> through the above narrow inlet, so that the protrusions <NUM> disposed on the outer walls of the hemispherical shell-shaped connecting portions <NUM> are stuck at a lower portion of the annular flange <NUM> to realize closed locking.

In the illustrated embodiment, inside the tube body <NUM>, two stepped regions with a smaller top and a larger bottom are also formed below the topmost cavity, and an inner diameter of an upper first region <NUM> is less than an inner diameter of a lower second region <NUM>. The plastic sleeve <NUM> and the steel sleeve <NUM> are disposed at the inside of the second region <NUM>. Besides, by forming three holes <NUM> in circumference of the second region <NUM> and by injecting glue into the tube body <NUM> of the fixed mount <NUM> through the holes <NUM>, the fixed mount <NUM> is bonded to the plastic sleeve <NUM>.

The structure of the ball head pull rod <NUM> is shown in <FIG>. The ball head pull rod <NUM> includes the pull rod <NUM> and the ball head <NUM> disposed at the front end of the pull rod <NUM>, and a diameter of the ball head <NUM> is greater than a diameter of the pull rod <NUM>.

The ball head <NUM> is limited to the inside of the hemispherical shell-shaped connecting portions <NUM> at the rear ends of the two clamping pieces <NUM>. Reciprocating motion of the ball head <NUM> forms reciprocating motion of the clamping pieces <NUM>, and at the same time, under the action of the fixing pin <NUM>, the two clamping pieces <NUM> are opened and closed. After the two clamping pieces <NUM> are closed, the ball head <NUM> continues moving rearward such that the two clamping pieces <NUM> are stuck at the inside of the fixed mount <NUM> and then the hemispherical shell-shaped connecting portions <NUM> at the rear ends of the two clamping pieces <NUM> are deformed, thereby realizing separation of the ball head <NUM> from the hemispherical shell-shaped connecting portions <NUM>.

The diameter of the pull rod <NUM> is equal to or slightly smaller than an inner diameter of the steel sleeve <NUM>, so that the pull rod <NUM> stably moves up and down along a hole in the steel sleeve <NUM>. The diameter of the ball head <NUM> is greater than the inner diameter of the steel sleeve <NUM>, and therefore, when the ball head <NUM> continues moving rearward after moving to a position in contact with the steel sleeve <NUM>, the ball head <NUM> drives the steel sleeve <NUM> to slide out of the plastic sleeve <NUM>.

The ball head pull rod <NUM> also includes a connecting tube <NUM>. A top of the connecting tube <NUM> is connected to the pull rod <NUM>. A bottom of the connecting tube <NUM> is configured to be connected to a pull rope. Specifically, a lower end of the pull rod <NUM> is inserted into the connecting tube <NUM> and fixed, and the pull rope is inserted into a hole <NUM> at the bottom of the connecting tube <NUM> and fixed, so that the ball head pull rod <NUM> is connected to the pull rope.

Structures of the plastic sleeve <NUM> and the steel sleeve <NUM> are as shown in <FIG>. An outer diameter of the plastic sleeve <NUM> matches an inner diameter of the bottommost region (that is, the second region <NUM>) of the fixed mount <NUM>. A size of an inner surface of the plastic sleeve <NUM> matches a size of an outer surface of the steel sleeve <NUM> at a portion fitting therewith.

As shown in <FIG> and <FIG>, the inner surface <NUM> of the plastic sleeve <NUM> is an inclined conical surface. An inner diameter of a top of the plastic sleeve <NUM> is greater than an inner diameter of a bottom of the plastic sleeve <NUM>.

As shown in <FIG>, the steel sleeve <NUM> is divided into upper and lower portions. The upper portion <NUM> is configured to match the plastic sleeve <NUM>, and the lower portion <NUM> is configured to connect a spring tube. Specifically, an outer surface of the upper portion <NUM> is a conical surface matching the inner surface <NUM> of the plastic sleeve <NUM>, and the outer surface of the upper portion <NUM> may form an interference fit with the inner surface of the plastic sleeve <NUM>. An outer surface of the lower portion <NUM> is a cylindrical surface, and may be inserted into the spring tube and fixed.

In the above structure, the plastic sleeve <NUM> and the steel sleeve <NUM> are disposed in the bottom cavity of the fixed mount <NUM>, and by pulling the ball head pull rod <NUM> rearward, the ball head <NUM> of the ball head pull rod <NUM> pushes the steel sleeve <NUM> to squeeze the plastic sleeve <NUM> to deform, so that the ball head pull rod <NUM> drives the steel sleeve <NUM> to slide out of the plastic sleeve <NUM>, thereby realizing separation of the control portion, which includes the ball head pull rod <NUM>, the steel sleeve <NUM>, and the spring tube and a control grip connected with the steel sleeve <NUM>, from the clamping portion at the front end of the hemostatic clamp. The clamping portion left in the body, including the two clamping pieces <NUM>, the fixed mount <NUM>, the fixing pin <NUM> and the plastic sleeve <NUM>, may be made of some degradable material.

A structure of the hemostatic clamp provided by the present invention has been described above, and an assembly process and a use process of the hemostatic clamp will be described in detail below with reference to <FIG>, <FIG>, <FIG> and <FIG>.

When the hemostatic clamp is assembled, firstly, the ball head <NUM> of the ball head pull rod <NUM> is placed in the hemispherical shell-shaped connecting portions <NUM> of the two clamping pieces <NUM>. The fixed mount <NUM> is sleeved over the two clamping pieces <NUM>, and the fixing pin <NUM> is inserted. A sheath cap may be sleeved over the outside of the fixing pin <NUM> to prevent the fixing pin <NUM> from coming off. Then, the plastic sleeve <NUM> and the steel sleeve <NUM> are sleeved over the pull rod <NUM> of the ball head pull rod <NUM>. The plastic sleeve <NUM> is inserted into a base of the fixed mount <NUM>. In order to enhance connection strength between the fixed mount <NUM> and the plastic sleeve <NUM>, the glue is dispensed at the three circular holes <NUM> reserved in the fixed mount <NUM> such that the plastic sleeve <NUM> and the fixed mount <NUM> are bonded together. Next, the ball head pull rod <NUM> is connected with the connecting tube <NUM> and then the connecting tube <NUM> is connected with the pull rope. Finally, a thin end of the steel sleeve <NUM> is inserted into an inner hole of the spring tube and welded with the spring tube together, and a grip component is mounted.

The above hemostatic clamp clamps a target affected part by closing the two symmetrical clamping pieces <NUM> to achieve the effects of stopping bleeding and closing a wound. Opened and closed states of the hemostatic clamp during tentative operation are respectively as shown in <FIG>, <FIG>, <FIG>. When the ball head pull rod <NUM> is pushed forward, the two clamping pieces <NUM> are opened under the action of the fixing pin <NUM> and the ball head <NUM>. When the ball head pull rod <NUM> is pulled rearward, the two clamping pieces <NUM> are closed under the action of the fixing pin <NUM> and the ball head <NUM>. As the ball head pull rod <NUM> reciprocates, the clamping pieces <NUM> may be opened and closed many times. In this process, the fixing pin <NUM> slides in the inclined portions <NUM> of the sliding slots <NUM> of the two clamping pieces <NUM>, and the hemispherical shell-shaped connecting portions <NUM> of the clamping pieces <NUM> move up and down between two branches of the fixed mount <NUM>.

As shown in <FIG>, when the hemostatic clamp clamps a target tissue, by pulling the ball head pull rod <NUM> rearward, the hemispherical shell-shaped connecting portions <NUM> move rearward. When the protrusions <NUM> on the outside of the hemispherical shell-shaped connecting portions <NUM> are stuck at the rear of the annular flange <NUM> of the topmost cavity <NUM> of the fixed mount <NUM>, the two clamping pieces <NUM> are in the closed locking position. At the same time, the fixing pin <NUM> slides into the bent portions <NUM> of the sliding slots <NUM> to realize synchronous locking.

By continuing pulling the ball head pull rod <NUM> rearward, the ball head <NUM> deforms the hemispherical shell-shaped connecting portions <NUM>, and the ball head <NUM> is separated from the hemispherical shell-shaped connecting portions <NUM>. By continuing pulling the ball head pull rod <NUM> rearward, the ball head <NUM> drives the steel sleeve <NUM> to force the plastic sleeve <NUM> to deform and to slide out of the plastic sleeve <NUM>, thereby realizing the separation of the clamping portion at the front end of the hemostatic clamp from the control portion at the rear end. Then, by pulling the pull rope rearward, the ball head pull rod <NUM>, the steel sleeve <NUM>, the spring tube and the like move rearward together.

The structure of the hemostatic clamp provided by the present invention and the tentative operation, closed locking and separation processes thereof are described in detail above. After the fixed mount <NUM>, the plastic sleeve <NUM> and the steel sleeve <NUM> of the hemostatic clamp are separated, the fixed mount <NUM>, the clamping pieces <NUM>, the fixing pin <NUM> and the plastic sleeve <NUM> are left in a human digestive tract. In order to facilitate elimination from the body, part or all of the fixed mount <NUM>, the clamping pieces <NUM>, the fixing pin <NUM> and the plastic sleeve <NUM> are recommended to be made of some degradable biological material, so that during hemostasis of the hemostatic clamp, the above components can be gradually decomposed and finally completely eliminated from the human body.

Based on the above, according to the hemostatic clamp provided by the present invention, the two clamping pieces are opened and closed through the ball head pull rod, and the clamping portion at the front end and the control portion at the rear end are separated through fit of the ball head pull rod with the plastic sleeve and the steel sleeve. Therefore, the hemostatic clamp has the advantages of simple structure, simple operation and high operation stability and is a hemostatic clamp suitable for wide use.

Claim 1:
A hemostatic clamp, comprising a fixed mount (<NUM>), two clamping pieces (<NUM>) and a ball head pull rod (<NUM>), the two clamping pieces (<NUM>) being oppositely disposed at a front end of the fixed mount (<NUM>), the ball head pull rod (<NUM>)comprising a pull rod (<NUM>) and a ball head (<NUM>) disposed at a front end of the pull rod (<NUM>), and the ball head pull rod (<NUM>) being configured to drive opening and closing of the two clamping pieces (<NUM>), wherein
a fixing pin (<NUM>) respectively passes through sliding slots (<NUM>) disposed in the middle of the two clamping pieces (<NUM>) and limits the two clamping pieces (<NUM>); the fixing pin (<NUM>) is configured to be slidable along the sliding slots (<NUM>), and the two clamping pieces (<NUM>) are configured to rotate around the fixing pin (<NUM>); and rear ends of the two clamping pieces (<NUM>) are respectively provided with a hemispherical shell-shaped connecting portion (<NUM>) where the ball head pull rod (<NUM>) is configured to drive opening and closing of the two clamping pieces (<NUM>) as the ball head (<NUM>) reciprocates in an up-down direction, enabling the rear ends of the two clamping pieces (<NUM>) to open and close, characterised in that, the hemostatic clamp also comprise a plastic sleeve (<NUM>) and a steel sleeve (<NUM>), the plastic sleeve (<NUM>) and the steel sleeve (<NUM>) being disposed on a lower portion of an inner cavity of the fixed mount (<NUM>), the plastic sleeve (<NUM>) being disposed between the steel sleeve (<NUM>) and an inner wall of the fixed mount (<NUM>); the ball head pull rod (<NUM>) passing through the steel sleeve (<NUM>); and after the ball head pull rod (<NUM>) is separated from the clamping pieces (<NUM>), by pulling the ball head pull rod (<NUM>) rearward, the ball head (<NUM>) driving the steel sleeve (<NUM>) to slide out of the plastic sleeve (<NUM>).