CN113749816A

CN113749816A - Delivery device and prosthesis system

Info

Publication number: CN113749816A
Application number: CN202111021444.XA
Authority: CN
Inventors: 刘琛; 聂京闽; 赵瑞辉; 岳斌; 葛亮
Original assignee: Shanghai Jingjie Medical Technology Co ltd
Current assignee: Shanghai Jingjie Medical Technology Co ltd
Priority date: 2021-09-01
Filing date: 2021-09-01
Publication date: 2021-12-07
Also published as: WO2023029732A1

Abstract

The invention relates to a delivery device and a prosthesis system, which are used for delivering a prosthesis implanted in joint tissues and a binding body for accommodating the prosthesis, and comprise an outer sheath tube, a connecting section and a binding body, wherein the outer sheath tube comprises an inner cavity, the distal end of the outer sheath tube is provided with the connecting section, the connecting section is configured to be connected with the binding body, the binding body comprises a binding cavity, and the binding cavity can movably accommodate the prosthesis; the outer catheter is movably arranged in the inner cavity of the outer sheath along the axial direction of the outer sheath, the proximal end of the outer catheter extends out of the proximal end of the outer sheath, and the distal end of the outer catheter is configured to limit the prosthesis from moving towards the proximal end in the inner cavity of the outer sheath; the inner catheter is movably arranged in the inner cavity of the outer catheter along the axial direction of the outer catheter, the proximal end of the inner catheter extends out of the proximal end of the outer catheter, and the distal end of the inner catheter is configured to be used for connecting the prosthesis. According to the delivery device, the far end of the outer sheath tube can be connected with the binding body, the outer catheter and the prosthesis can be accommodated in the inner cavity of the outer sheath tube simultaneously, and the prosthesis and the binding body can be implanted simultaneously.

Description

Delivery device and prosthesis system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a conveying device and a prosthesis system.

Background

The rotator cuff is a muscle-tendon structure connecting the scapula and the humeral head, and is located on the outer layer of the shoulder joint capsule and the inner layer of the deltoid. The rotator cuff consists of a front rotator cuff (subscapularis), an upper rotator cuff (supraspinatus and subscapularis) and a rear rotator cuff (subscapularis and teres minor), and the rotator cuff has certain functions of inward rotation, outward rotation and outward expansion of the upper arm, and has the main functions of stabilizing the position of the humeral head on the glenoid during movement, and avoiding pain caused by the humeral head moving upwards to impact the acromion. Therefore, the rotator cuff plays an extremely important role in maintaining the stability of the shoulder joint and in moving the shoulder joint.

However, with age, repeated shoulder joint movement for a long time, hyperosteogeny under the shoulder or repeated violent movement may cause abrasion and tearing of soft tissues under the shoulder (joint bursa and rotator cuff), so that the stability and mobility of the humeral head are damaged, the arm of the patient cannot be abducted or lifted during the shoulder joint movement, severe pain is caused by impact between the sclerotin or the sclerotin and the rotator cuff, and the patient cannot sleep at night due to pain, thereby seriously affecting the quality of life and the self-care ability.

Currently, the pain caused by rotator cuff injury can be treated by implanting a prosthesis (such as a rotator cuff) by a delivery device, such as the 201910147605.6 patent application, wherein the prosthesis is implanted at a preset position of a shoulder joint by the delivery device having a delivery catheter and a driving rod, the distal end of the delivery catheter is communicated with a cavity of the prosthesis during delivery, and the driving rod is used for sealing a liquid injection port of the prosthesis. However, the variety of prostheses is great, and the related art has a prosthesis structure in which a binding body (such as a balloon cuff) is wrapped outside the prosthesis, rather than having only a single structure of the prosthesis, for which the delivery device of the related art cannot implant the prosthesis and the binding body at a predetermined position of the shoulder joint at the same time.

Disclosure of Invention

In view of the above, it is necessary to provide a delivery device and a prosthesis system for the problem that the new type of prosthesis cannot be successfully implanted into the shoulder joint.

The invention provides a delivery device for delivering a prosthesis implanted in the tissues of a joint and a tether containing said prosthesis, comprising:

a sheath comprising an inner lumen and a distal end of the sheath having a connecting section configured for connection to the tether, the tether comprising a tether lumen that is movable to receive the prosthesis;

an outer catheter movably disposed in the lumen of the outer sheath in an axial direction of the outer sheath, with a proximal end of the outer catheter extending from the proximal end of the outer sheath, a distal end of the outer catheter being configured for restricting proximal movement of the prosthesis in the lumen of the outer sheath;

an inner catheter movably disposed in the lumen of the outer catheter along the axial direction of the outer catheter with a proximal end of the inner catheter extending from the proximal end of the outer catheter, a distal end of the inner catheter being configured for connection to the prosthesis.

In one embodiment, the delivery device further comprises:

a seal configured to seal against the prosthesis, the seal coupled to a distal end of the inner catheter, the inner catheter further configured to drive the seal to move and seal against the prosthesis.

In one embodiment, the delivery device further comprises:

a puncture sheath configured for use with the outer sheath for guiding the tether into a target tissue.

In one embodiment, the puncture sheath is movably sleeved outside the outer sheath, and the proximal end of the outer sheath extends out of the proximal end of the puncture sheath.

In one embodiment, a first outer expanding pipe is arranged at the proximal end of the outer sheath pipe, the distal end of the first outer expanding pipe is communicated with the proximal end of the outer sheath pipe, and the diameter of the first outer expanding pipe is gradually increased from the distal end to the proximal end; and/or the presence of a gas in the gas,

the near-end of puncture sheath pipe has the second and expands the pipe, the distal end of second expand the pipe with the near-end intercommunication of puncture sheath pipe, just the second expand the pipe diameter from the far-end to the direction of near-end and increase gradually.

In one embodiment, the difference between the inner diameter of the penetrating sheath and the outer diameter of the outer sheath is greater than twice the wall thickness of the tether.

In one embodiment, the delivery device further comprises:

a handle having a hollow passageway through its distal and proximal ends; the proximal end of the outer catheter is fixed with the distal end of the handle and is coaxially communicated with the distal end of the hollow channel; the inner catheter is movably arranged in the inner cavity of the outer catheter and the hollow channel along the axial direction of the outer catheter and extends out of the proximal end of the hollow channel.

In one embodiment, the handle is provided with a control mechanism, and the control mechanism is in control connection with the inner catheter and is used for controlling the inner catheter to retract in the proximal direction relative to the outer catheter.

In one embodiment, the control mechanism comprises:

a control button disposed on the handle for locking or releasing the inner catheter;

an elastic member elastically fitted between the handle and the inner catheter for applying an elastic force to the inner catheter for driving the inner catheter to be withdrawn in a proximal direction so as to be withdrawn in the proximal direction after being released.

In one embodiment, the control button comprises a button key and an unlocking key, the button key is in limit abutment with the inner catheter to enable the inner catheter to be locked, and the unlocking key is in control connection with the button key and is used for controlling the button key to release the inner catheter;

and/or the presence of a gas in the gas,

the elastic part is a spring, the spring is sleeved outside the inner catheter, one end of the spring is connected with the near end of the handle, and the other end of the spring is connected with the inner catheter and used for applying the elastic force to the inner catheter.

The invention also provides a prosthesis system comprising:

the conveying device;

the binding body is provided with an opening communicated with the binding cavity, and the connecting section is configured to be connected with the opening;

the prosthesis, which can be in an atrophic state or an expanded state, comprises a cavity and an injection port communicating with the cavity, the cavity being configured for filling with an filling substance to bring the prosthesis in the expanded state; the prosthesis is configured to be constrained within the outer sheath in the collapsed state or movably contained within the constrained lumen in the expanded state, a distal end of the outer catheter being configured for retaining abutment with the prosthesis.

In one embodiment, the injection device further comprises a sealing element for blocking the injection opening, and the sealing element and the injection opening are both connected with the distal end of the inner catheter.

In one embodiment, the prosthesis system further comprises:

a connecting portion having a through hole passing through distal and proximal ends thereof; the distal end of the connecting portion is in communication with the injection port, and the distal end of the outer catheter is configured for positive abutment with the proximal end of the connecting portion for indirect positive abutment with the prosthesis via the connecting portion.

In one embodiment, the prosthesis system further comprises:

a fixing member disposed on the tether, the tether being securable between the shoulder and the humeral head by the fixing member.

In one embodiment, the fixing member comprises at least one fixing wire, one end of the fixing wire is connected with the binding body, and the other end of the fixing wire is configured for connecting with a shoulder peak.

The conveying device is characterized in that an outer sheath tube is additionally arranged for realizing the simultaneous implantation of the prosthesis and the bounding body, the distal end of the outer sheath tube can be connected with the bounding body and communicated with the bounding cavity of the bounding body, the distal end of an outer catheter can limit the proximal movement of the prosthesis in the inner cavity of the outer sheath tube, the outer catheter and the prosthesis can be accommodated in the inner cavity of the outer sheath tube simultaneously, and the prosthesis is connected by an inner catheter.

Drawings

FIG. 1 is a schematic structural diagram of a conveying apparatus according to an embodiment of the present invention 1;

FIG. 2 is a drawing of the structure of FIG. 1 in a retracted state;

FIG. 3 is a schematic structural diagram of a conveying apparatus according to an embodiment of the present invention, shown in FIG. 2;

FIG. 4 is a view of the structure of FIG. 3, illustrating the state of use of FIG. 2;

FIG. 5 is an enlarged view of a portion of FIG. 1 in the use state shown in FIG. 4;

FIG. 6 is a view of FIG. 2 showing the structure of FIG. 3 in a state of use;

FIG. 7 is an enlarged view of a portion of FIG. 2 in the use state shown in FIG. 6;

FIG. 8 is a schematic structural diagram of a conveying apparatus according to an embodiment of the present invention, shown in FIG. 3;

FIG. 9 is a schematic structural diagram of a conveying apparatus in an embodiment of the present invention 4;

FIG. 10 is a schematic view of a binder according to an embodiment of the present invention;

FIG. 11 is a schematic view of an assembled structure of a tether and a prosthesis according to an embodiment of the present invention;

FIG. 12 is a schematic view of a prosthesis system in an embodiment of the present invention in use;

FIG. 13 is a schematic view of a prosthesis system in an embodiment of the present invention in use;

FIG. 14 is a schematic view of a prosthesis system in an embodiment of the present invention in use;

FIG. 15 is a schematic diagram of a prosthesis system in an embodiment of the present invention in use state 4.

Reference numerals:

001. skin; 002. acromion; 003. a humeral head;

100. an outer sheath tube; 200. an outer catheter; 300. an inner conduit; 400. puncturing a sheath tube; 500. a handle; 600. a tether; 700. a prosthesis; 800. a seal member; 900. a luer fitting;

110. a connecting section; 120. limiting the space; 130. a first externally expanded pipe;

410. a second outer expanding tube;

510. a control button; 520. an elastic member;

511. a button key; 512. an unlocking key;

610. an opening; 620. a fixing member;

710. an injection port; 720. a connecting portion.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

To more clearly describe the structure of the delivery system, the term "distal" is defined herein to mean the end of the system distal to the operator during a surgical procedure, and "proximal" to mean the end of the system proximal to the operator during a surgical procedure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

The existing delivery device generally comprises a delivery catheter and a driving rod which are movably sleeved with each other, when the prosthesis is implanted, the distal end of the delivery catheter can be communicated with a liquid injection port of the prosthesis, meanwhile, the driving rod is axially and movably arranged in the delivery catheter and extends out of the distal end of the delivery catheter to be connected with a sealing element in a cavity of the prosthesis, therefore, an implantation channel is formed after skin around the shoulder joint is opened by means of a sheath catheter with a puncture function or by means of a scalpel and the like, and the prosthesis can be implanted to a preset position of the shoulder joint by means of the delivery catheter along the implantation channel.

However, for prosthesis 700 (rotator cuff) having a tether 600 (cuff), there is no way to implant such prosthesis 700 because the distal end of the delivery catheter is already connected to prosthesis 700 and therefore cannot be used to connect to tether 600, and because tether 600 needs to be fitted over the exterior of prosthesis 700 to contain prosthesis 700 within the lumen of tether 600, a delivery device having only a delivery catheter has no way to implant such prosthesis 700.

In order to solve the problem of the prior art, the present application provides a solution to the development of a delivery device for the diversification of the types of the prosthesis 700, so as to improve the structure of the delivery device to satisfy the implantation of different types of the prosthesis 700, thereby promoting the development of medical devices. The prosthesis 700 may be a balloon applied to various joints of the human body, and may be not only a rotator cuff balloon but also a balloon for treating various joint positions such as a knee joint.

The binding body 600 may be a mesh-like body or a sleeve-like body, for example, a mesh-like body made of a metal material, a mesh-like structure woven by using a wire, or the like, or a sleeve-like body made of a metal material, or a sleeve-like structure woven by using a wire and having a density higher than that of the mesh-like structure. Both the mesh and the sleeve are capable of forming a binding cavity within them, as can be seen in fig. 10 and 11, i.e. the inner cavity of the mesh and the inner cavity of the sleeve. The prosthesis 700 may be loaded into the restraining chamber of the body 600 and when the body 600 is secured in a predetermined position in the shoulder joint, will also secure the prosthesis 700 in a somewhat mobile state in the predetermined position in the shoulder joint, the somewhat mobile state depending on the relative size relationship between the restraining chamber and the prosthesis 700, although being mobile, is not able to escape from the restraining chamber, i.e. not the movement between the prosthesis 700 and the predetermined position in the shoulder joint, but rather the degree of mobility in relation to the restraining chamber. In designing the relative size between the constraining lumens and the prosthesis 700, which may be set according to the degree of motion allowed for the prosthesis 700, the prosthesis 700 may be provided with an appropriate amount of motion space (expressed in terms of the size of the constraining lumens), but not so much motion space as to lose the constraining effect on the prosthesis 700. The delivery device provided by the present invention is specifically designed for implantation of such a prosthesis 700 configuration.

Referring to fig. 1 and 2, an embodiment of the present invention provides a delivery apparatus for delivering a prosthesis 700 implanted in joint tissue, which is not limited to a human joint or an animal joint, and including but not limited to shoulder joints, knee joints, etc., the delivery device includes an outer sheath 100, an outer catheter 200, an inner catheter 300, said outer sheath 100 containing a lumen, and the distal end of the sheath tube 100 has a connection section 110, the connection section 110 is configured to connect the tether 600, the binding body 600 includes a binding cavity that movably receives the prosthesis 700, the connection mode of the connection section 110 for connecting the binding body is detachable connection, including but not limited to sleeving, wrapping, clamping and gluing, the binding body 600 can be connected with the connecting section through the binding cavity, for example, the binding body is directly sleeved on the connecting section of the sheath tube; the outer catheter 200 is movably disposed in the lumen of the outer sheath 100 in the axial direction of the outer sheath 100, and the proximal end of the outer catheter 200 extends from the proximal end of the outer sheath 100, and the distal end of the outer catheter 200 is configured to limit proximal movement of the prosthesis 700 in the lumen of the outer sheath 100; the inner catheter 300 is movably disposed in the inner lumen of the outer catheter 200 in the axial direction of the outer catheter 200, and the proximal end of the inner catheter 300 extends from the proximal end of the outer catheter 200, and the distal end of the inner catheter 300 is configured to be connected to the prosthesis 700.

The outer catheter 200 is adapted to define a limiting space 120 for limiting the movement of the prosthesis 700 in the lumen of the outer sheath 100 in a state that the outer catheter 200 is engaged with the outer sheath 100, the limiting space 120 is located between the distal end of the outer sheath 100 and the distal end of the outer catheter 200, the limiting space 120 is actually a part of the space in the lumen of the outer sheath 100, the limiting space 120 is substantially defined at the distal end portion of the outer sheath 100, the actual position and size of the limiting space 120 can be determined according to the actual position of the outer catheter 200 in the lumen of the outer sheath 100 and is mainly located in at least a part of or all of the space between the distal end of the outer sheath 100 and the distal end of the outer catheter 200. While the prosthesis 700 may be in an collapsed state, in which the prosthesis 700 is confined within the confined space 120, or in an expanded state, in which the distal end of the inner catheter 300 is connected to the prosthesis 700.

Compared with a delivery device which can only deliver the prosthesis 700, in order to realize the simultaneous implantation of the prosthesis 700 and the bounding body 600, the delivery device is additionally provided with the outer sheath tube 100, so that the outer catheter 200 and the outer sheath tube 100 together form the delivery device, the connecting section 110 at the distal end of the outer sheath tube 100 of the delivery device can be connected with the bounding body 600 and communicated with the bounding cavity of the bounding body 600, the distal end of the outer catheter 200 of the delivery device can define the limiting space 120 in the inner cavity of the outer sheath tube 100, the prosthesis 700 is accommodated and limited by the limiting space 120, the outer catheter 200 and the prosthesis 700 can be accommodated in the inner cavity of the outer sheath tube 100 simultaneously, therefore, after the outer sheath tube 100 with the bounding body 600 is implanted to the preset position of the shoulder joint, the outer catheter 200 and the prosthesis 700 can be implanted to the preset position of the shoulder joint simultaneously, and the movable accommodation of the prosthesis 700 in the bounding cavity of the bounding body 600 is not influenced, satisfying the smooth implantation of the new type of prosthesis 700.

The reason why the outer sheath 100 can be coupled with the binder 600 at the distal end thereof is that the distal end of the outer sheath 100 has the coupling section 110, which is also a key for the sheath structure to be distinguished from the sheath structure for puncture, but does not mean that the outer sheath 100 having the coupling section 110 cannot be used for puncture, but the sheath structure for puncture functions differently from the outer sheath 100 having the coupling section 110, and cannot be used for coupling with the binder 600. The structure of the connecting section 110 may be designed specifically for the purpose of facilitating the connection of the binding body 600, and the structure of the connecting section 110 may be different from or the same as that of the other parts of the outer sheath 100.

In other embodiments, when the structure of the connecting section 110 is different from the structure of other parts of the outer sheath 100, the connecting section 110 may have a non-tubular regular geometric structure or a non-regular geometric structure, such as a sphere, an ellipsoid, a cube, etc., each having a common inner cavity with the structure of other parts of the outer sheath 100. The connecting section 110 may also be tubular, and the diameter of the tubular connecting section 110 may be larger or smaller than the other portions of the sheath 100. Or a separate different structure, such as a step, a thread or a slit, may be formed at the connection position between the connection section 110 and other structures of the outer sheath 100, and the purpose of the various structures is to facilitate the connection section 110 to form a secure socket with the opening 610 of the binding body 600.

Of course, the connecting section 110 can also be the same structure as the other parts of the sheath 100, i.e. the whole sheath 100 is a regular tubular structure, except that the distal end of the sheath 100 is limited to a suitable distance, and the connecting section 110 is formed by the distance, and the connecting section 110 is only used for connecting the binding body 600, and is not usually used for other purposes such as puncturing. As for the specific structure of the connection segment 110, those skilled in the art can arrange the connection segment according to the requirement, and the structure is not limited herein.

When prosthesis 700 is adapted to a shoulder joint, the rotator cuff balloon used in prosthesis 700 may be a plurality of different types of rotator cuff balloons (rotator cuff balloons refer to balloons, balloons that are used exclusively for implanting into a shoulder joint in the treatment of rotator cuff injury), for example, the rotator cuff balloon may have a structure in which the injection port 710 is isolated by a semi-permeable membrane, the pore size of the semi-permeable membrane is designed to allow only filling materials, such as saline, to pass through but not sealing materials, such as bone cement, to pass through, so that the injection port 710 can be sealed by bone cement after the saline is injected, and the inner catheter 300 can be used to sequentially inject the saline and the bone cement into the cavity of the rotator cuff balloon.

Referring to fig. 3 to 7, the rotator cuff balloon may also have a structure in which a sealing member 800 is used to seal a filling port 710, the sealing member 800 is configured to seal the prosthesis 700, the sealing member 800 is connected to the distal end of the inner catheter 300, and the inner catheter 300 is further configured to drive the sealing member 800 to move and seal the prosthesis 700. The prosthesis 700 comprises a cavity configured for being filled with an inflating substance to cause the prosthesis 700 to assume the expanded state, and an injection port 710 communicating with the cavity; the sealing member 800 may be pre-disposed in the cavity of the rotator cuff balloon, the inner catheter 300 may be in interference fit with the injection port 710 after extending into the injection port 710, and is used to inject physiological saline or other filling substances into the cavity of the rotator cuff balloon, the proximal end of the inner catheter 300 is disposed with a luer 900, the luer 900 may facilitate opening and closing of the proximal end of the inner catheter 300, the size of the specific type of the luer 900, etc. may be determined according to the matching requirement of the inner catheter 300, and is not limited herein.

After the cavity is filled, the inner tube 300 can be inserted into the cavity to insert the sealing member 800 and form a plug connection with the sealing member 800, which can be a plug connection without penetration, and then the inner tube 300 is withdrawn in the proximal direction to move the sealing member 800 toward the injection opening 710, so that the sealing member 800 blocks the injection opening 710. As the inner catheter 300 continues to be withdrawn proximally, the sealing member 800 will more tightly seal within the injection port 710, and as the withdrawal force of the inner catheter 300 increases, the sealing member 800 will eventually tightly seal within the injection port 710 and separate from the inner catheter 300, thereby sealing the injection port 710 with the sealing member 800.

In addition to the two types of shoulder sleeve balloons listed, the prosthesis 700 may also be of any suitable configuration, and may be selected by one skilled in the art as desired and not limited thereto. In addition, the sealing element 800 may not be pre-disposed in the cavity of the prosthesis 700, the inner catheter 300 may detachably connect the sealing element 800 to the distal end of the inner catheter 300 when the injection port 710 needs to be sealed, the inner catheter 300 drives the sealing element 800 to approach the injection port 710 by moving along the axial direction of the outer catheter 200, as long as the inner cavity of the outer catheter 200 can allow the sealing element 800 to move smoothly, and the volume of the sealing element 800 can satisfy the sealing of the injection port 710, for example, the cross section of the inner cavity of the outer catheter 200 is larger than the cross section of the injection port 710, and there is no problem of mutual interference in shape. At this time, the sealing member 800 may be pushed into the cavity of the rotator cuff by the pushing force of the inner catheter 300 advancing to the distal end, and the injection port 710 may be sealed from the cavity of the rotator cuff as it is, and if the sealing reliability is satisfied, the sealing member 800 may form an abutting seal on the injection port 710 at the outside of the injection port 710, thereby sealing the injection port 710, which is not limited.

When the prosthesis 700 and the binding body 600 are implanted by the delivery device, an implantation channel needs to be formed at a target position, that is, when a predetermined position of the shoulder joint is the target position, an implantation channel communicating with the predetermined position needs to be formed on the shoulder joint, the implantation channel is formed in order to enable the outer sheath 100 and the outer catheter 200 to carry the prosthesis 700 and the binding body 600 to the predetermined position, and the implantation channel can be formed by using a scalpel or a sheath structure for puncture, and the formation mode can be various.

Referring to fig. 8 and 9, the delivery device further includes a puncture sheath 400, the puncture sheath 400 being configured for use with the outer sheath 100 for guiding the tether 600 into a target tissue. For example, the puncture sheath 400 is movably sleeved outside the sheath 100, so that the sheath 100 is movably disposed in the inner cavity of the puncture sheath 400 along the axial direction of the puncture sheath 400, and the proximal end of the sheath 100 extends from the proximal end of the puncture sheath 400. When the prosthesis 700 and the tether 600 are implanted by the delivery device, the puncture sheath 400, the outer sheath 100 and the outer catheter 200 can be punctured together toward a predetermined position of the shoulder joint, the puncture sheath 400 can form a tiny implantation channel by puncturing the skin 001, the outer sheath 100 and the tether 600 are initially accommodated in the puncture sheath 400, the outer catheter 200 and the prosthesis 700 are initially accommodated in the outer sheath 100, the outer sheath 100 can enter the implantation channel along the inner cavity of the puncture sheath 400 with the tether 600 at the distal end thereof along the implantation channel with the formation of the implantation channel, and the implantation of the tether 600 is realized as the implantation channel enters a predetermined position of the shoulder joint, for example, between the shoulder peak 002 and the humeral head 003, and the prosthesis 700 is initially accommodated in the inner cavity of the outer sheath 100, and can be injected with an inflating substance and moved into the tether cavity of the tether 600 at a proper stage during the implantation of the tether 600, and as the tether 600 reaches a predetermined position of the shoulder of the joint, the prosthesis 700 may simultaneously reach a predetermined location of the shoulder joint, such as between the shoulder 002 and the humeral head 003, to achieve isolation between the shoulder 002 and the humeral head 003, forming a lever action, and solving the collision problem between the shoulder 002 and the humeral head 003.

The binding body 600 can be connected with the distal end of the outer sheath 100 in a plurality of ways, the opening 610 of the binding body 600 can be sleeved outside the distal end of the outer sheath 100, the distal end of the outer sheath 100 can also be sleeved outside the opening 610 of the binding body 600, at this time, the opening 610 of the binding body 600 needs to be designed into a tubular structure capable of being sleeved with the distal end of the outer sheath 100, and the size of the opening 610 can also meet the entrance of the prosthesis 700, or the opening 610 of the binding body 600 can also be connected with the distal end face of the outer sheath 100, and the connection form can be bonding, clamping and the like, which is not limited herein. For the opening 610 of the binding body 600 to be sleeved outside the distal end of the outer sheath tube 100, since the binding body 600 has a wall thickness and the outer sheath tube 100 needs to be flexibly moved axially in the puncture sheath tube 400, the difference between the inner diameter of the puncture sheath tube 400 and the outer diameter of the outer sheath tube 100 is larger than twice the wall thickness of the binding body, i.e. the minimum radius (inner diameter) of the puncture sheath tube 400 at least needs to be equal to the sum of the maximum radius (outer diameter) of the outer sheath tube 100 and the thickness of the binding body 600, and preferably larger than the sum of the maximum radius of the outer sheath tube 100 and the thickness of the binding body 600, so as to provide enough space for the flexible movement of the binding body 600 and the outer sheath tube 100 in the puncture sheath tube 400.

Referring to fig. 8 and 9, a first flared tube 130 is disposed at a proximal end of the outer sheath 100, a distal end of the first flared tube 130 is communicated with the proximal end of the outer sheath 100, and a diameter of the first flared tube 130 gradually increases from the distal end to the proximal end, so that the first flared tube 130 facilitates delivery of the prosthesis 700 to a lumen of the outer sheath 100. The proximal end of puncture sheath 400 has second outer expand tube 410, the distal end of second outer expand tube 410 with the proximal end intercommunication of puncture sheath 400, just second outer expand tube 410 is from distal end to the direction of proximal end pipe diameter increase gradually, and second outer expand tube 410 can make things convenient for the internal chamber of the body 600 of restricting to puncture sheath 400 to deliver.

The delivery device further includes a handle 500, the handle 500 having a hollow passageway through its distal and proximal ends; the proximal end of the outer catheter 200 is fixed to the distal end of the handle 500 and is in coaxial communication with the distal end of the hollow channel; the inner catheter 300 is movably disposed in the lumen of the outer catheter 200 and the hollow passage in the axial direction of the outer catheter 200, and protrudes from the proximal end of the hollow passage. The handle 500 has an effect of being convenient to hold, the handle 500 is connected with the outer catheter 200, the outer catheter 200 can be primarily controlled by holding the handle 500, and after the outer catheter 200 is stably controlled, the outer sheath 100 movably sleeved outside the outer catheter 200 can be conveniently operated. For a delivery device having an inner catheter 300, the outer catheter 200 is in coaxial communication with the hollow passageway, forming a communicating passageway, such that the inner catheter 300 is axially movable within the lumen of the outer catheter 200 and the hollow passageway of the handle 500, with the proximal end of the inner catheter 300 extending from the proximal end of the hollow passageway, enabling manipulation of the inner catheter 300 by an operator. In order to facilitate the operator to hold the proximal end of the inner catheter 300, the proximal end of the inner catheter 300 may further be provided with a tip member or other solid structure having holding and limiting functions, such as still using the luer 900. The luer 900, in addition to its own function, is intended to be held and to prevent the inner catheter 300 from being fully inserted into the hollow passageway and being inoperable. For a delivery device having a puncture sheath 400, the puncture sheath 400 may be movably sheathed outside the outer sheath 100, and an operator may directly control the puncture sheath 400 externally.

When the delivery device is provided with the puncture sheath 400, the outer sheath 100, the outer catheter 200 and the inner catheter 300, the handle 500 is not necessarily connected to the outer catheter 200, and besides, the distal end of the handle 500 may be connected to the proximal end of the outer sheath 100, and the outer sheath 100 is coaxially communicated with the distal end of the hollow channel, so that the outer catheter 200 and the inner catheter 300 can be axially and movably controlled in the hollow channel, or the distal end of the handle 500 may be connected to the proximal end of the puncture sheath 400, and the puncture sheath 400 is coaxially communicated with the distal end of the hollow channel, so that the outer sheath 100, the outer catheter 200 and the inner catheter 300 can be axially and movably controlled in the hollow channel, or even the distal end of the handle 500 may be connected to the proximal end of the inner catheter 300, so that the puncture sheath 400, the outer sheath 100 and the outer catheter 200 can be axially and movably controlled outside the inner catheter 300, which can be set by those skilled in the art according to the needs, and are not intended to be limiting.

That is, the delivery device needs to include at least the outer catheter 200 and the outer sheath 100, and the inner catheter 300 may be provided separately, the puncture sheath 400 may be provided separately, or the inner catheter 300 and the puncture sheath 400 may be provided simultaneously.

With continued reference to fig. 4-7, the handle 500 is provided with a control mechanism in controlling connection with the inner catheter 300 for controlling the proximal withdrawal of the inner catheter 300 relative to the outer catheter 200. The control mechanism may take various forms as long as it can achieve the automatic retraction of the inner catheter 300, for example, the control mechanism includes a control button 510, an elastic member 520, the control button 510 is disposed on the handle 500 for locking or releasing the inner catheter 300; the elastic member 520 is elastically fitted between the handle 500 and the inner catheter 300, and serves to apply an elastic force to the inner catheter 300 for driving the proximal withdrawal thereof, so that the inner catheter 300 is withdrawn in the proximal direction after being released.

The control knob 510 locks the inner catheter 300 to keep the inner catheter 300 relatively stable with respect to the outer catheter 200, and this stable state allows filling material to be injected into the cavity of the prosthesis 700 through the inner catheter 300, or at this time, if the seal 800 is provided in the cavity of the prosthesis 700, the inner catheter 300 can form a stable plug connection with the seal 800. When the control button 510 releases the inner tube 300, the inner tube 300 is unlocked, and automatically retracts under the elastic force provided by the elastic member 520, so that the sealing member 800 is sealed at the injection port and separated from the sealing member 800, and finally the sealing member 800 is left alone at the injection port 710 to form a seal.

In one embodiment, the control button 510 comprises a button key 511 and an unlocking key 512, the button key 511 is in limit abutment with the inner catheter 300 to lock the inner catheter 300, and the unlocking key 512 is in control connection with the button key 511 for controlling the button key 511 to release the inner catheter 300. The elastic member 520 is a spring, the spring is sleeved outside the inner catheter 300, one end of the spring is connected with the proximal end of the handle 500, and the other end of the spring is connected with the inner catheter 300, and is used for applying the elastic force to the inner catheter 300 to control the retraction of the inner catheter 300.

Referring to fig. 10 to 15, the present invention further provides a prosthesis 700 system, comprising a delivery device, a constraining body 600, a prosthesis 700, wherein the constraining body 600 has an opening 610 communicating with a constraining cavity thereof, the connecting section 110 is configured for connecting with the opening 610, the prosthesis 700 can be in an atrophic state or an expanded state, the prosthesis 700 comprises a cavity and an injection port 710 communicating with the cavity, the cavity is configured for being filled with a filling material to make the prosthesis 700 in the expanded state; the prosthesis 700 is configured to be confined within the outer sheath 100, in particular the confined space 120, in the collapsed state, or movably accommodated within the constrained lumen in the expanded state, the distal end of the outer catheter 200 being configured for a stop abutment with the prosthesis 700.

The shrinking state of the prosthesis 700 means that the prosthesis 700 can shrink its volume, the shrinking degree depends on the transportation requirement, and the shrinking state of the prosthesis 700 is ensured to be able to be accommodated in the transportation device and smoothly transported to the predetermined position, the shrinking shape of the prosthesis 700 in the shrinking state is not limited as long as the transportation requirement is met, for example, when the transportation device transports the prosthesis 700 by using the transportation catheter, the shrinking state of the prosthesis 700 needs to be matched with the tubular lumen of the transportation catheter, and is accommodated in the transportation catheter in a long strip shape.

Accordingly, the expanded state is relative to the atrophic state, the expanded state of the prosthesis 700 means that the prosthesis 700 can expand its own volume, the degree of expansion depends on the repair requirement of the shoulder joint, and the expanded volume of the prosthesis 700 is ensured to form an effective support between the shoulder peak and the humeral head, so as to maintain and increase the distance between the shoulder peak and the humeral head, thereby achieving the therapeutic effect, the expanded shape of the prosthesis 700 in the expanded state is not limited as long as the effective support between the shoulder peak and the humeral head is satisfied, for example, the prosthesis 700 in the expanded state is a sac-shaped structure with a certain thickness, and both side surfaces of the sac-shaped structure have surface shapes that are gently attached to the internal tissue structures of the shoulder joint, such as tendon, humeral head, shoulder peak, and the like.

The prosthesis 700 has a small overall volume when in an atrophic state and can be accommodated in the cavity of the sheath 100, and the prosthesis 700 has a larger overall volume when in an expanded state, so that the shoulder 002 and the humeral head 003 can be separated after being implanted into the shoulder joint, and a lever effect is formed between the shoulder 002 and the humeral head 003 to prevent the shoulder 002 from colliding with the humeral head.

Referring to fig. 12, the prosthesis 700 has a cavity and an injection port 710 communicating with the cavity, the injection port 710 and the distal end of the outer catheter 200 are in limit contact with each other and are limited in the limited space 120, at this time, the prosthesis 700 is in an shrinking state, the volume of the prosthesis 700 is reduced, and the prosthesis 700 can be accommodated in the inner cavity of the sheath tube 100 together with the outer catheter 200. The binder 600 has an opening 610 communicating with the binder lumen thereof, and the opening 610 is connected to the connecting section 110 of the outer sheath 100, so that the inner lumen of the outer sheath 100 communicates with the binder lumen through the opening 610, and the outer catheter 200 together with the prosthesis 700 can be extended into the binder lumen from the inner lumen of the outer sheath 100. The prosthesis system further includes a sealing member 800 for blocking the injection port 710, both the sealing member and the injection port 710 being connected to the distal end of the inner catheter 300.

Referring to fig. 13, the implantation path forming the predetermined position communicating with the shoulder joint is formed by using a puncture sheath 400, in which the puncture sheath 400 is also fitted over the sheath 100, and the puncture sheath 400, the sheath 100 and the outer catheter 200 together penetrate the skin 001 to reach the predetermined position of the shoulder joint. In addition, the formation of the implantation channel can be referred to the above description, and is not described herein.

Referring to FIG. 14, after the prosthesis 700 and the tether 600 have reached the predetermined position, the inner catheter 300 may be used to inject an inflation substance, such as saline, into the lumen of the prosthesis 700 to transition the prosthesis 700 from the collapsed state to the expanded state. The outer catheter 200 is in limit abutment with the opening 610 of the prosthesis 700, the limit abutment can be in direct abutment or indirect abutment, namely the distal end of the outer catheter 200 is in direct contact with and forms abutment with the opening 610 of the prosthesis 700, and the indirect abutment is the distal end of the outer catheter 200 is not in direct contact with the opening 610 of the prosthesis 700, for example, the prosthesis 700 system further comprises a connecting part 720, and the connecting part 720 is provided with a through hole penetrating through the distal end and the proximal end of the connecting part 720; a connector 720 is provided on the prosthesis 700, and a distal end of the connector 720 is in communication with the injection port 710, and a distal end of the outer catheter 200 is configured for positive abutment with a proximal end of the connector 720, so as to be in positive abutment with the prosthesis 700 via the connector 720. The connecting portion 720 may be a tubular member to facilitate the engagement with the distal end of the outer catheter 200, and the connecting portion 720 may be in other regular or irregular geometric shapes, which is not limited herein.

At this time, the binding body 600 may be fixed at a predetermined position of the shoulder joint, the binding body 600 is fixed, and the prosthesis 700 is fixed by the binding body 600 to a degree that the prosthesis 700 cannot be released from the binding of the binding body 600, and only the prosthesis 700 is allowed to move within the binding cavity of the binding body 600. This both ensures fixation of the prosthesis 700 and allows the prosthesis 700 to automatically adapt to the movements of the shoulder joint within the range of permitted movements, extending the life of the prosthesis 700.

As far as the fixation of the tethers 600 at the shoulder joint locations is concerned, it may be performed before or after the filling, as long as it is ensured that the prosthesis 700 and the tethers 600 remain stable after implantation. The fixation of the tether 600 may take various forms, for example, the tether 600 may be expanded by the volume of the prosthesis 700 after filling, while also having a certain degree of expansion, and thus be compressively fixed between the shoulder 002 and the humeral head 003. However, since the tether 600 needs to be fixed in advance and provide a space for the prosthesis 700 to move by using its tether cavity, the prosthesis 700 system further includes a fixing member 620, and the fixing member 620 is disposed on the tether 600 to fix the tether 600 between the shoulder peak 002 and the humeral head 003 after the tether 600 is implanted into the shoulder joint. The specific form of the fixing element 620 may be any suitable structural form such as a sheet, a line, a strip, etc., and the fixing manner of the fixing element 620 on the shoulder 002 or the humeral head 003 may be implemented by a suitable surgical manner such as a rivet, etc., which is not limited herein. In one embodiment, the fixing member 620 is at least one fixing wire, and the fixing wire can be connected to the shoulder 002 or the humeral head 003 when the constraint body 600 is fixed, which can be selected according to various factors such as convenience of actual operation, injury benefit and disadvantage, and the like.

After the filling material is injected into the cavity of the prosthesis 700 and the prosthesis 700 is transformed into the expanded state, the inner catheter 300 may bring the sealing member 800 to seal the injection port 710 of the prosthesis 700, and then the inner catheter 300 may be withdrawn, while the outer catheter 200 is also withdrawn. As for the specific sealing manner in which the inner conduit 300 drives the sealing member 800 to seal the injection port 710 of the prosthesis 700, and the manner in which the inner conduit 300 and the sealing member 800 are not used to seal the injection port 710 of the prosthesis 700, reference may be made to the foregoing description, which is not repeated herein.

Referring to fig. 15, prosthesis 700 expands upon filling and remains stably in the restraining lumen of the restraint body 600, and with the restraint body 600 in place, the prosthesis 700 and restraint body 600 are successfully implanted into the shoulder joint. At this time, the inner catheter 300 (if any), the outer catheter 200, the outer sheath 100 and the puncture sheath 400 may be withdrawn from the shoulder joint, leaving only the prosthesis 700 and the tether 600 in the shoulder joint, and thereby completing the revision surgery.

The technical features of the above embodiments can be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the above embodiments are not described, but should be considered as the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above examples only show some embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A delivery device for delivering a prosthesis implanted in joint tissue and a tether housing the prosthesis, comprising:

2. The delivery device of claim 1, further comprising:

3. The delivery device of claim 1, further comprising:

4. The delivery device of claim 3, wherein said puncture sheath is movably disposed over said outer sheath, and wherein said proximal end of said outer sheath extends from said proximal end of said puncture sheath.

5. The delivery device of claim 3, wherein the proximal end of the outer sheath is provided with a first flared tube, the distal end of the first flared tube is communicated with the proximal end of the outer sheath, and the diameter of the first flared tube gradually increases from the distal end to the proximal end; and/or the presence of a gas in the gas,

6. The delivery device of claim 3, wherein the difference between the inner diameter of the puncture sheath and the outer diameter of the outer sheath is greater than two times the wall thickness of the tether.

7. The delivery device of any of claims 1-6, further comprising:

8. The delivery device of claim 7, wherein the handle is provided with a control mechanism in controlling connection with the inner catheter for controlling withdrawal of the inner catheter in a proximal direction relative to the outer catheter.

9. The delivery device of claim 8, wherein the control mechanism comprises:

10. The delivery device of claim 9, wherein the control button comprises a button key in positive abutment with the inner catheter to cause the inner catheter to be locked and an unlocking key in controlled connection with the button key for controlling the button key to release the inner catheter;

and/or the presence of a gas in the gas,

11. A prosthesis system, comprising:

the delivery device of any one of claims 1-10;

12. The prosthesis system of claim 11, further comprising a sealing member for blocking the injection port, the sealing member and injection port each being connected to the distal end of the inner catheter.

13. The prosthesis system of claim 11, further comprising:

14. The prosthesis system of claim 11, further comprising:

15. The prosthesis system of claim 14, wherein the fixation member comprises at least one fixation wire having one end connected to the tether and another end configured for connection to a shoulder peak.