CN112971947A

CN112971947A - Transplanting device

Info

Publication number: CN112971947A
Application number: CN201911300264.8A
Authority: CN
Inventors: 谢文滔; 宗果; 吴艳雪; 邢贝贝
Original assignee: Shanghai Mingyue Medical Technology Co ltd
Current assignee: Shanghai Mingyue Medical Technology Co ltd
Priority date: 2019-12-16
Filing date: 2019-12-16
Publication date: 2021-06-18

Abstract

The invention provides an implantation device, which comprises an inner tube and a first connecting piece used for connecting a conveying device, wherein the near end of the inner tube is connected with the first connecting piece, the first connecting piece is communicated with the inner cavity of the inner tube, and the implantation device also comprises a balloon and a second connecting piece used for connecting a pressure device; the balloon is sleeved on the inner tube, and an filling cavity is formed between the inner tube and the balloon; the balloon comprises an expandable balloon body and a balloon extension part, the balloon extension part is tubular, the far end of the balloon body is fixed on the outer side of the far end of the inner tube, the near end of the balloon body is connected with the balloon extension part, the balloon body is communicated with the balloon extension part, and the balloon extension part is connected with and communicated with the second connecting piece.

Description

Transplanting device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a transplanting device.

Background

Embryo transfer tubes are used during the transfer of gametes, zygotes, zygote embryos or blastocysts produced by in vitro fertilization and gamete intrafallopian transfer into the uterine cavity or into the oviduct (abbreviated as GIFT). At present, embryo transplantation tubes are generally divided into four types according to whether stainless steel sleeves and lining cores are contained or not, wherein the type I is simpler and comprises an inner tube, an outer tube, a conical joint and a protective sleeve, the type IV is more complex, a stainless steel tube and lining core components are added compared with the type I, and the stainless steel tube is mainly used for supporting the inner tube and improving the integral rigidity; the lining core is used for assisting the outer tube to establish a channel so that the inner tube can pass through the cervical orifice conveniently when the cervix is narrow and the inner tube is difficult to pass through.

The embryo transplantation tube in the market at present consists of two parts, an outer tube (or a tube with a lining core) is used by a clinician, the embryo transplantation tube is placed into a cervix through a vagina before transplantation operation (if necessary, the embryo transplantation tube needs to be guided in advance by the lining core), and a channel can be established to facilitate the inner tube to enter a uterus; meanwhile, medical staff connect the injector and the inner tube (can be provided with a stainless steel tube) in a laboratory, and the embryo is sent into the uterus through the placed outer tube after being sucked, so that the transplantation is completed, and the operation steps of the whole process are relatively complicated. The inner tube cannot damage embryos, so the material of the inner tube is required to be soft, a stainless steel tube is generally added on the basis of the I-type and II-type inner tubes and is mainly used for supporting the inner tubes, but the stainless steel tube can cause adverse reactions such as intimal injury, bleeding and the like in the transplantation process, the cost of the metal stainless steel tube is relatively high, and the compatibility with other high polymer materials is poor.

In the process of embryo transplantation, in order to reduce adverse stress reactions such as uterine contraction or bleeding, medical staff usually select a catheter with a proper size and material for transplantation, the diameter of a conventional embryo transplantation tube is 3-5 mm, and the conventional embryo transplantation tube has great selectivity for a normal uterine tube/uterine cavity, but due to inflammation, trauma, uterine curettage, abortion, uterine aspiration or excessive uterine curettage and the like, the basal layer of an endometrium is damaged, secondary inflammation exists in a mucosa of the cervical tube, the uterine tube or the endometrium is adhered, and the cervical tube is narrowed or even blocked. For a normal embryo transfer catheter, as the diameter of the outer tube is larger than the size of the adhered or locked cervical tube, the forced introduction easily causes adverse reactions such as uterine contraction, pain, endomembrane bleeding and the like; however, although the diameter of the inner tube with the stainless steel tube is small, the material is soft and lacks rigidity, and the stainless steel tube only has partial length and cannot effectively enter the adhesion or locking part. Therefore, medical staff can use cervical dilating rods/devices with different sizes to dilate before transplantation, but repeated dilatation easily causes the situation of uterine bleeding again, infection or intimal injury, and is not suitable for embryo transplantation at this time, but timely transplantation is not performed after the dilatation, so that the dilated cervical canal tissues can return to the contraction state before the dilatation, and the dilatation needs to be performed again when next transplantation is performed. The whole transplantation process is complicated, and the expensive cost is required to be borne, so that the psychology and the physiology of the patient are greatly painful.

Aiming at the problems in the technology, a transplanting device is to be developed, the problems can be effectively solved, and the market and clinical requirements can be better met.

Disclosure of Invention

In order to overcome the defects of the prior art, the invention aims to provide a transplantation device, which abandons the use of a stainless steel pipe in the prior art, avoids the damage of a hard stainless steel pipe to human tissues and plays a role of rigid support; avoids repeated use of cervical dilating rods/devices with different sizes, and reduces adverse reactions such as uterine bleeding, cross infection or intimal injury.

In order to achieve the above object, the present invention provides an implantation device, comprising an inner tube and a first connector for connecting a delivery device, wherein the proximal end of the inner tube is connected with the first connector, and the first connector is communicated with the inner cavity of the inner tube, wherein the implantation device further comprises a balloon and a second connector for connecting a pressure device;

the balloon is sleeved on the inner tube, and an filling cavity is formed between the inner tube and the balloon;

the balloon comprises an expandable balloon body and a balloon extension part, the balloon extension part is tubular, the far end of the balloon body is fixed on the outer side of the far end of the inner tube, the near end of the balloon body is connected with the balloon extension part, the balloon body is communicated with the balloon extension part, and the balloon extension part is connected with and communicated with the second connecting piece.

Preferably, the length of the balloon body in the axial direction is slightly shorter than that of the inner tube, the length of the inner tube is 150-300 mm, and the length of the balloon body is 100-250 mm.

Preferably, the length of the distal end of the inner tube exposed out of the balloon body is greater than or equal to 2 mm.

Preferably, the balloon body has an outer diameter of 10mm or less after being inflated.

Preferably, the transverse cross section of the balloon body after being inflated is circular or elliptical.

Preferably, the balloon body distal end is concave inwardly or convex forwardly upon inflation.

Preferably, the balloon body is pressurized with a liquid or gas.

Preferably, the balloon body surface is coated with a hydrophilic/oleophilic coating or a hydrophobic/oleophobic coating.

Preferably, a through hole is formed in the balloon extension part, and the second connecting piece is communicated with the balloon extension part through the through hole.

Preferably, the outer diameter of the inner pipe is 0.5-2 mm.

Preferably, the inner tube is made of medical plastic with the hardness of 70D-30A.

Preferably, the inner pipe is made of one or a mixture of more than two of TPU, Pebax, PA, PVC and silica gel, or a composite material formed by more than two materials.

Preferably, the distal end of the balloon body is fixed outside the distal end of the inner tube in an end sealing manner by ultrasonic welding or hot melting.

Preferably, the balloon body is made of medical plastic with 70D-30A of hardness and semi-compliance or low compliance.

Preferably, the balloon body is made of one or a mixture of more than two of TPU, Pebax, PA, PVC and silica gel or a composite material formed by more than two materials.

Preferably, the pressure device is a syringe or an insufflator and the delivery device is a syringe.

Preferably, the liquid is physiological saline or sterile water; the gas is air.

Preferably, the first connector is a standard luer fitting adapted to a syringe and the second connector is a standard luer fitting adapted to the pressure device.

Preferably, the first connecting piece is fixedly arranged on the inner pipe through a first external thread; the second connecting piece is fixedly arranged on the balloon body through a second external thread.

Preferably, the grafting device is a coaxial double-lumen catheter structure.

Preferably, the balloon body is expandable laterally/longitudinally.

Compared with the prior art, the transplantation device provided by the embodiment of the invention has the following beneficial effects:

1. the transplantation device is additionally provided with the saccule which can be expanded transversely/longitudinally on the basis of the traditional embryo transplantation inner tube, and a certain pressure can be filled to keep the rigidity of the inner tube before transplantation, so that the saccule replaces the original stainless steel tube, and a certain pressure can be applied to the saccule according to the rigidity required to support the inner tube, thereby being convenient for absorbing and transplanting embryos; meanwhile, the saccule adopts a high polymer material with better biocompatibility, so that stress reaction is reduced.

2. After entering the vagina, the transplanting device can apply pressure with different sizes to expand according to the narrow condition of the cervical canal (particularly the cervical adhesion or the closed part), thereby avoiding the repeated use of cervical expanding rods/devices with different sizes, not only reducing the complexity of procedures, but also reducing the adverse reactions of uterine bleeding, cross infection, intimal injury and the like caused by the repeated use of the cervical expanding rods/devices with different sizes.

3. The balloon body on the transplantation device is provided with a hydrophilic or oleophilic special coating on the surface, so that the adverse phenomena of uterine contraction, pain, endomembrane bleeding and the like caused when the transplantation device enters the cervix can be effectively reduced, and the treatment effect is improved.

Drawings

FIG. 1 is a schematic view of the overall structure of an implantation device according to an embodiment of the present invention;

FIG. 2 is a schematic axial cross-sectional view of an implantation device in accordance with an embodiment of the invention;

FIG. 3 is a schematic transverse cross-sectional view of an implantation device in accordance with an embodiment of the invention;

FIG. 4 is a schematic axial cross-sectional view of the first and second coupling members of the grafting device according to one embodiment of the invention;

FIG. 5 is a schematic cross-sectional view of a balloon body of the implantation device of the present invention after being inflated;

fig. 6 is a schematic axial cross-sectional view of the distal end of the balloon body of the implantation device of the present invention being inwardly concave or forwardly convex after being inflated.

Wherein: 110-an inner tube; 120-a first connector; 130-a second connector; 140-a balloon body; 141-balloon body distal end; 142-a balloon body proximal end; 150-a balloon extension; 160-a first external thread; 170-second external thread; 101-filling the cavity; 102-target embryo.

Detailed Description

In order to make the technical disclosure of the present invention more complete and complete, the transplantation device of the present invention will be further described in detail with reference to the accompanying drawings and the following embodiments of the present invention. The same reference numbers in the drawings identify the same or similar elements. However, it will be understood by those of ordinary skill in the art that the examples provided below are not intended to limit the scope of the present invention. In addition, the drawings are only for illustrative purposes and are not drawn to scale. As used herein, "proximal" refers to the end that is closer to the operator of the implantation device, and "distal" refers to the end that is further from the operator of the implantation device. The plane parallel to the axis is an axial section, and the plane vertical to the axis is a transverse section.

Fig. 1 is a schematic view showing the overall construction of an implanting device according to an embodiment of the present invention, fig. 2 is a schematic view showing an axial cross section of an implanting device according to an embodiment of the present invention, fig. 3 is a schematic view showing a transverse cross section of an implanting device according to an embodiment of the present invention, and fig. 4 is a schematic view showing axial cross sections of a first connecting member and a second connecting member of an implanting device according to an embodiment of the present invention.

Referring to fig. 1 to 4, the transplantation device of the present invention includes an inner tube 110 and a first connector 120 for connecting a delivery means, and a proximal end of the inner tube 110 is connected to the first connector 120. The implantation device further comprises a balloon and a second connector 130 for connecting the pressurizing means. The balloon is sleeved on the inner tube 110, an inflation cavity 101 is formed between the inner tube 110 and the balloon, the balloon comprises a balloon body 140 capable of being inflated and a balloon extension portion 150, the balloon body 140 can be expanded transversely/longitudinally, the balloon extension portion 150 is tubular, the proximal end 142 of the balloon body 140 is connected to the balloon extension portion 150, the balloon body 140 is communicated with the balloon extension portion 150, the distal end 141 of the balloon body 140 is fixed to the outer side of the distal end of the inner tube 110, and the balloon extension portion 150 is connected with the second connecting member 130.

In this embodiment, the structure of the implantation device will be described by taking as an example a state in which the balloon body 140 is pressurized, and fig. 1 to 4 show schematic views in which the balloon body 140 is pressurized. Specifically, the length of the inner tube 110 is generally set between 150 mm to 300mm, the outer diameter is generally set between 0.5 mm to 2mm, and the length of the balloon body 140 is generally set between 100 mm to 250 mm. The balloon body 140 is slightly shorter than the inner tube 110, so that most of the inner tube 110 can be covered by the balloon body 140, and after the balloon body 140 is pressurized, the whole inner tube 110 can be supported, so that the inner tube 110 is not bent when entering the uterus, and the target embryo 102 can be conveniently sucked and transplanted. Preferably, the distal end 141 of the balloon body 140 may be fixed to the outer side of the distal end of the inner tube 110 in an end-sealing manner by ultrasonic welding or hot melting, but the present embodiment is not limited thereto, and the connection manner between the balloon body 140 and the inner tube 110 is not limited. The length of the distal end of the inner tube 110 exposed out of the balloon body 140 is greater than or equal to 2mm, and the smaller the exposed distance is, the smaller the wound on the human body is, because the balloon in the embodiment mainly plays a role in supporting the inner tube 110, the closer the distal end of the balloon is to the distal end of the inner tube 110, the better the supporting effect is theoretically ensured. Preferably, the inner tube 110 may be made of medical plastic with a hardness of 70D-30A, specifically, one or a mixture of two or more of Thermoplastic Polyurethane (TPU), block polyether amide (Pebax), nylon (PA), polyvinyl chloride (PVC), and silicone, or a composite material formed by two or more of these materials, which is not limited in practical application.

The balloon body 140 may be made of a semi-compliant or low-compliant medical plastic with a hardness of 70D-30A, specifically, may be made of one or a mixture of two or more of Thermoplastic Polyurethane (TPU), block polyether amide (Pebax), nylon (PA), polyvinyl chloride (PVC), and silica gel, or may be made of a composite material formed by two or more of these materials, where a polymer material with better biocompatibility is used to reduce the stress reaction during the embryo transplantation process, and the application is not limited thereto. The material of the inner tube 110 and the balloon body 140 is not limited in this embodiment.

Preferably, the surface of the balloon body 140 in this embodiment is coated with a hydrophilic/lipophilic coating or a hydrophobic/oleophobic coating, which can effectively reduce the adverse phenomena of uterine contraction, pain, endomucosal bleeding and the like caused when the transplantation device enters the cervix, and improve the treatment effect.

Fig. 5 is a schematic transverse cross-sectional view of the balloon body 140 of the implantation device of the present invention after being inflated. In the initial state of the implantation device provided by the embodiment of the invention, the balloon is folded, and can be transversely/longitudinally expanded according to the shape of the balloon cavity after being pressurized. The allowable outer diameter of the balloon body 140 under the pressurizing condition is less than or equal to 10mm, and the transverse cross-sectional structure of the balloon body 140 after being pressurized can be circular or elliptical, and is circular in this embodiment. Fig. 6 is an axial cross-sectional view illustrating that the distal end of the balloon body of the implantation device of the present invention is concave or convex after being pressurized, and referring to fig. 6, the distal end 141 of the balloon body 140 may be concave or convex after being pressurized, in this embodiment, the distal end 141 of the balloon body 140 is convex.

In this embodiment, the implantation device is a coaxial double lumen catheter structure, i.e., the balloon and inner tube 110 of the implantation device are coaxial and double lumen. With reference to fig. 4, the first connector 120 is disposed on the inner tube 110, and the first connector 120 and the inner tube 110 can be connected by gluing, a first external thread 160 is disposed at an inlet of the first connector 120, and a conveying device, such as a syringe, is connected to the first connector 120 through the first external thread 160 and further communicated with the inner tube 110.

The inlet end of the second connector 130 is provided with a second external thread 170, and the pressurizing device, such as a syringe or an inflator, is connected to the second connector 130 through the second external thread 170, and the other end of the second connector 130 is connected to the balloon extension 150, such as by gluing. A through hole is formed in the balloon extension portion 150, and the other end of the second connecting member 130 is connected and communicated with the balloon extension portion 150 through the through hole, so that the pressurizing device is communicated with the filling cavity 101.

The first connector 120 is, for example, a standard luer fitting that fits a delivery device such as a conventional syringe; the second connector 130 is, for example, a standard luer connector, and is adapted with a pressurizing device, such as a conventional syringe, an inflator, or other pressurizing device, for pressurizing the balloon body 140 with a liquid, such as saline or sterile water, or a gas, such as air.

The embodiment of the invention provides a transplanting device which comprises the following specific use steps:

the liquid pressurization is taken as an example for explanation. The filling device is filled with normal saline, and the balloon body 140 is filled with normal saline after the second connecting member 130 is connected, so that the balloon body 140 supports the soft inner tube 110 after being filled with pressure, and the inner tube 110 has certain rigidity under the pressure support.

The injector is connected with the first connecting piece 120, a small amount of culture solution in the culture dish is sucked, the culture solution, the air section, the target embryo 102, the air section and the culture solution are sequentially sucked, the embryo falling condition is avoided, meanwhile, the target embryo 102 is prevented from being adhered to the outer wall of the transplanting device in the transplanting process, the target embryo 102 can be pushed out of the transplanting device, and the target embryo 102 is pushed in the pipeline of the inner pipe 110 along the direction shown by the arrow in fig. 1.

After the object is ready for body position, the transplanting device enters the cervical orifice through the vagina, when the transplanting device enters the narrow cervical canal part, when the distal end of the inner tube 110 enters the narrow or closed cervical canal part, the balloon body 140 is pressurized for the second time through the filling device, or the balloon body 140 is pressurized for multiple times according to the narrow degree of the cervix, so that the balloon body 140 presents different expansion degrees, the pressure is kept for 5min, the separation of the cervical adhesion part can be observed through ultrasound, at the moment, the transplanting device is continuously pushed forwards, and the processes are repeatedly carried out until the transplanting device smoothly reaches the uterine cavity (the process can be observed by means of the ultrasonic equipment).

The transfer device transfers the target embryo 102 into the uterine cavity to complete the transfer.

Finally, the pressure inside the balloon body 140 is relieved by the inflator and the implantation device is removed.

It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the invention and are not to be construed as limiting the embodiments of the present invention, and that various other changes and modifications may be made by those skilled in the art based on the above description. All documents mentioned in this application are incorporated by reference into this application as if each were individually incorporated by reference.

Claims

1. An implantation device, comprising an inner tube and a first connector for connecting to a delivery device, the proximal end of the inner tube being connected to the first connector, and the first connector being in communication with the lumen of the inner tube, characterized in that: the implantation device further comprises a balloon and a second connector for connecting a pressure device;

2. The grafting device of claim 1, wherein: the length of the balloon body in the axial direction is slightly shorter than that of the inner tube, the length of the inner tube is 150-300 mm, and the length of the balloon body is 100-250 mm.

3. The grafting device of claim 1, wherein: the length of the far end of the inner tube exposed out of the balloon body is more than or equal to 2 mm.

4. The grafting device of claim 1, wherein: the outer diameter of the balloon body after being pressurized is less than or equal to 10 mm.

5. The grafting device of claim 1, wherein: the transverse section of the balloon body after being inflated is circular or elliptical.

6. The grafting device of claim 1, wherein: the distal end of the balloon body is concave inwards or convex forwards after being inflated.

7. The grafting device of claim 1, wherein: and pressurizing the balloon body by selecting liquid or gas.

8. The grafting device of claim 1, wherein: the surface of the balloon body is coated with a hydrophilic/oleophilic coating or a hydrophobic/oleophobic coating.

9. The grafting device of claim 1, wherein: the balloon extension part is provided with a through hole, and the second connecting piece is communicated with the balloon extension part through the through hole.

10. The grafting device of claim 1, wherein: the outer diameter of the inner pipe is 0.5-2 mm.