Patent Description:
For patients with cavity stenosis caused by advanced lung cancer, patients with lumen external pressure type stenosis caused by mediastinal and esophageal tumors, and patients with tumors who are old and cannot tolerate surgery in poor general conditions, the emergence of Y-shaped stents solves the complications of lumen stenosis and stent displacement very well.

For implanting a traditional Y-shaped stent implantation apparatus, firstly, a front handle is withdrawn to extend branches of a Y-shaped stent, then, the branches of the stent are released by loosening binding wires, a positioning lock is unscrewed, and the front handle is continuously withdrawn to completely release the stent. The operation process is cumbersome, and the operation takes a long time. The knots of the binding wires cause certain damage to erosive tissues. The release of a pulling wire requires a certain force, which tends to shift the stent shift, and results in the failure of operation. The binding wires need sufficient tensile strength, otherwise the binding wires may break during the operation to cause the failure of the device. When the stent is bound, the binding wires need to be knotted with slipknots one by one, otherwise the binding wires cannot be loosened during the operation to cause the failure of operation.

Therefore, there is an urgent need for an implantation apparatus that is easy to operate and can effectively release the stent, so as to solve the problems that the traditional stent implantation apparatus is difficult to operate and the operation takes too much time, and to overcome a series of safety hazards caused by the binding wires.

<CIT> discloses a medical device implantation apparatus with the features of the first part of claim <NUM>. <CIT> and <CIT> both disclose a further medical device implantation apparatus.

The purpose of the present invention is to design a medical device implantation apparatus, which is suitable for a medical device with branches, such as Y-shaped stents. By constraining the distal end of the medical device product, the effect of positioning the distal end of the medical device is achieved. The operation is easier, so that the operation time is shortened while the damage to the tumor tissue is reduced, and the patient's pain is reduced. Moreover, the probability of apparatus failure is reduced.

The invention provides a medical device implantation apparatus with the features of claim <NUM>.

The medical device implantation apparatus comprises an outer sheath, a middle sheath, an inner sheath, outer casings, and a medical device, wherein the outer sheath is connected to a first portion of a handle and extends from a proximal end to a distal end; the middle sheath is arranged in the outer sheath, and is connected to a second portion of the handle; the inner sheath is allowed to pass through the middle sheath and is connected to a third portion of the handle, and the inner sheath is movable relative to the outer sheath; the number of the outer casings is at least two; a distal end of the inner sheath is respectively fixedly connected to the outer casings; and the medical device is arranged around the inner sheath and partially accommodated in the outer casings. The inner sheath moves relative to the outer sheath by manipulating the third portion of the handle to release the medical device. The inner sheath has a distal end bifurcation structure that is respectively connected to the outer casings.

According to an embodiment, the outer casing includes a part for fixing the inner sheath and a part for fixing the medical device.

According to an embodiment not covered by the wording of the claims, the inner sheath includes a first inner sheath and a second inner sheath which are distributed side by side, and the tail end of the distal end of the inner sheath is respectively connected to the outer casings.

According to an embodiment not covered by the wording of the claims, the first inner sheath and the second inner sheath are the same in length or different in length.

According to an embodiment, the medical device is a stent.

According to an embodiment, the middle sheath is connected to the second portion of the handle through a booster sheath.

According to an embodiment, the booster sheath is made of metal.

According to an embodiment, a positioning lock is arranged between the first portion of the handle and the second portion of the handle.

List of reference numerals in the drawings:.

The technical solution of the present invention is described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are only used to explain the present invention, and not to limit the present invention. The scope of the application is not limited by these embodiments, the scope of the invention is defined by the claims. In order to provide a clearer description and enable those familiar with the art to understand the application content of the present application, the various parts in the figures are not necessarily drawn according to their relative dimensions, and the ratio of certain dimensions to other relevant dimensions is highlighted and exaggerated. The details that are irrelevant or unimportant are not completely drawn in order to keep the diagram concise.

The invention provides a medical device implantation apparatus. The medical device implantation apparatus comprises an outer sheath, a middle sheath, an inner sheath, outer casings, and a medical device, wherein the outer sheath is connected to a first portion, namely, a front handle part, of a handle and extends from a proximal end to a distal end; the middle sheath is arranged in the outer sheath, and is connected to a second portion, namely, a rear handle part, of the handle; the inner sheath is allowed to pass through the middle sheath and is connected to a third portion, namely, an adjusting handle, of the handle, and is movable relative to the outer sheath; the number of the outer casings is at least two; a distal end of the inner sheath is respectively fixedly connected to the outer casings; and the medical device is arranged around the inner sheath and partially accommodated in the outer casings. The inner sheath moves relative to the outer sheath by manipulating the third portion of the handle to release the medical device.

According to an embodiment, the outer casing includes a part for fixing the inner sheath and a part for fixing the medical device. The part for fixing the inner sheath and the part for fixing the medical device can be of the same structure or different structures.

According to an embodiment, the inner sheath can have a cavity at the proximal end and a bifurcation structure at the distal end, and the tail end of the bifurcation structure of the inner sheath is respectively connected to the outer casings.

According to an embodiment, the middle sheath is connected to the second portion of the handle through a booster sheath, and the proximal end of the middle sheath is fixedly connected to the booster sheath and then connected to the handle. The proximal end of the middle sheath can also be directly connected to the handle.

According to an embodiment, the booster sheath is made of metal, including medical stainless steel.

As shown in <FIG>, the present invention provides a medical device implantation apparatus, which includes an outer casings <NUM>, an inner sheath <NUM>, a middle sheath <NUM>, an outer sheath <NUM>, a booster sheath <NUM>, and a handle <NUM>, wherein the handle <NUM> includes three parts, specifically the front handle part <NUM>, the rear handle part <NUM>, and the adjusting handle <NUM>.

The number of the outer casings <NUM> is two or more. The outer casings <NUM> comprises at least a first outer casing <NUM> and a second outer casing <NUM>. The first outer casing <NUM> and the second outer casing <NUM> can be of one-stage type structures, two-stage type structures or three-stage type structures, and are used for fixing the inner sheath <NUM> and containing the medical device. Preferably, as shown in <FIG>, the first outer casing <NUM> and the second outer casing <NUM> are of hollow three-stage structures, and each includes a distal end inner hole <NUM>, a middle section inner hole <NUM> and a proximal end inner hole <NUM>. Medical guide wires can extend through the distal end inner holes <NUM> from the proximal end to the distal end, and are used for guiding the medical device implantation apparatus to reach the desired position. The inner sheath <NUM> can be fixed in the middle section inner holes <NUM>. The distal end inner hole <NUM> and the middle section inner hole <NUM> can be designed as two parts separately or as an integral part. Compression stent branches <NUM> and <NUM> are fixed in the proximal end inner holes <NUM>.

According to an embodiment not covered by the wording of the claims, the inner sheath <NUM> includes a first inner sheath <NUM> and a second inner sheath <NUM>. The first outer casing <NUM> and the second outer casing <NUM> respectively wrap and fix the distal end of an inner sheath <NUM>. The first outer casing <NUM> and the second outer casing <NUM> are located on the outer side of the distal end of the inner sheath <NUM>. A curved angle structure with a certain arc is formed at the connection between the end surface of the distal end of the outer casing <NUM> and the side wall of the outer casing <NUM> to avoid damage to a human body lumen during use. The first inner sheath <NUM> and the second inner sheath <NUM> are arranged side by side, and the medical guide wires can respectively pass through the interiors of the first inner sheath <NUM> and the second inner sheath <NUM>. The distal ends of the first inner sheath <NUM> and the second inner sheath <NUM> are respectively wrapped by the first outer casing <NUM> and the second outer casing <NUM>. The proximal ends of the first inner sheath <NUM> and the second inner sheath <NUM> are connected to the adjusting handle <NUM> through the rear handle part <NUM>. The first inner sheath <NUM> and the second inner sheath <NUM> are of hollow structures, and the guide wires can pass through the interiors of the inner sheath <NUM> and the second inner sheath <NUM>. According to the invention, the inner sheath <NUM> is designed as a distal end bifurcation structure, and portions of the distal end bifurcation structure are connected to the first outer casing <NUM> and the second outer casing <NUM> respectively.

The middle sheath <NUM> covers at least part of the inner sheath <NUM>. The distal end of the middle sheath <NUM> is abutted against the proximal end of a stent main branch <NUM> to limit the position of the stent. The proximal end of the middle sheath <NUM> can be designed to be connected to the rear handle part <NUM>, or the proximal end of the middle sheath <NUM> is connected to the booster sheath <NUM>. The booster sheath <NUM> is of a hollow structure, and the distal end of the booster sheath <NUM> is fixedly connected to the proximal end of the middle sheath <NUM>. The booster sheath <NUM> is made of metal, which helps to transmit force when the medical device is released. The proximal end of the booster sheath <NUM> is connected to the rear handle part <NUM>. As the middle sheath <NUM> is made of polymer plastic, the middle sheath <NUM> is relatively soft; and the booster sheath <NUM> is made of metal, such as medical stainless steel. Therefore, the middle sheath <NUM> has good flexibility and bendability when entering the human body lumen, and the booster sheath <NUM> is helpful for the transmission of force during the implantation and release of the medical device. A developing part <NUM> is arranged on the outer wall of the distal end of the middle sheath <NUM>. The developing part <NUM> can be embedded on the outer wall of the middle sheath <NUM> or placed on the outer surface of the middle sheath <NUM> in other ways, which facilitates the positioning and release of the medical device during the operation.

The outer sheath <NUM> is located on the outer side of the middle sheath <NUM>, covers at least part of the middle sheath <NUM>, and is movable relative to the inner sheath <NUM>. The proximal end of the outer sheath <NUM> is connected to a front handle part <NUM>. The outer side of the outer sheath <NUM> can be surrounded by soft materials, so that during surgery, especially when the outer sheath turns a corner, the irritation to the human body lumen can be reduced.

The handle <NUM> is located at the proximal end of the medical device implantation apparatus and comprises the front handle part <NUM>, the rear handle part <NUM> and the adjusting handle <NUM>. The front handle part <NUM> is located at the distal end of the handle <NUM> and is connected to the proximal end of the outer sheath <NUM>. The proximal end of the front handle <NUM> is provided with a safety lock <NUM> composed of a locking screw and a locking nut. The front handle part <NUM> can be fixed on the booster sheath <NUM> by screwing, and plays a role in positioning. The rear handle part <NUM> is located between the front handle part <NUM> and the adjusting handle <NUM> and is connected to the proximal end of the booster sheath <NUM>. The adjusting handle <NUM> is located at the proximal end of the medical device implantation apparatus, and is connected to the tail end of the proximal end of the inner sheath <NUM>. A positioning lock <NUM> is arranged between the front handle part <NUM> and the rear handle part <NUM> and covers the boost sheath <NUM>.

The outer casing <NUM> can be used for compressing the stent. The stent can include the stent main branch <NUM> and the stent branches <NUM> and <NUM>. The two stent branches <NUM> and <NUM> can be the same in length or different in length. As shown in <FIG>, the two stent branches <NUM> and <NUM> of the stent are different in length. As the first inner sheath <NUM> and the second inner sheath <NUM> are different in length, the two branches <NUM> and <NUM> of the stent are respectively sleeved on the first inner sheath <NUM> and the second inner sheath <NUM>, thereby being compressed into the first outer casing <NUM> and the second outer casing <NUM> respectively. The stent branches <NUM> and <NUM> are confined in the proximal end inner holes <NUM> of the outer casing <NUM>.

The medical device implantation apparatus of the present invention can convey including but not limited to the self-expandable stent, and can also convey other medical devices that can be released from the implantation apparatus by withdrawing the outer sheath <NUM> relative to the inner sheath <NUM>.

As shown in <FIG>, the implantation process of the medical device implantation apparatus is as follows: firstly, the distal ends of the two stent branches <NUM> and <NUM> of the stent are respectively compressed and placed into the outer casing <NUM>; then the main stent <NUM> covers the inner sheath <NUM>, and the positioning lock <NUM> is locked, so that the main stent <NUM> is fixed on the booster sheath <NUM>; after the outer sheath <NUM> covers the stent main branch <NUM> and the stent branches <NUM> and <NUM>, the safety lock <NUM> is screwed, and the stent assembly is completed. When the positioning lock <NUM> is fixed, the position of the the positioning lock is close to the safety lock <NUM>, and can prompt the doctor that when the front handle part <NUM> is withdrawn to the positioning lock <NUM>, the stent branches <NUM> and <NUM> are released from the outer sheath <NUM>.

Claim 1:
A medical device implantation apparatus, comprising:
an outer sheath, connected to a first portion of a handle and extending from a proximal end to a distal end;
a middle sheath, the middle sheath being arranged in the outer sheath, and the middle sheath being connected to a second portion of the handle;
an inner sheath, the inner sheath being allowed to pass through the middle sheath, the inner sheath being connected to a third portion of the handle, and the inner sheath being movable relative to the outer sheath;
outer casings, with at least two outer casings being provided; and
a medical device, arranged around the inner sheath, wherein the inner sheath moves relative to the outer sheath by manipulating the third portion of the handle to release the medical device,
wherein the medical device is partially accommodated in the outer casings,
characterized in that
the inner sheath has a distal end bifurcation structure, and portions of the distal end bifurcation structure are connected to the first outer casing (<NUM>) and the second outer casing (<NUM>), respectively
wherein during implantation a distal end of the middle sheath is abutted against a proximal end of the medical device to limit the position of the medical device.