CN115670934A - A gastrostomy device - Google Patents

Abstract

The invention discloses a gastrostomy device, which comprises: a tube extending axially from a proximal end to a distal end; the joint is arranged at the near end of the tube body; the outer fixing pad is arranged on the tube body, and the far end of the outer fixing pad is suitable for being attached to and contacted with the outer wall of the abdomen; the inner fixing object is arranged at the far end of the pipe body, at least part of the inner fixing object is woven by shape memory alloy wires, the inner fixing object is suitable for being constrained into a tightening state by a constrained object, after the constraint of the constrained object is relieved, the inner fixing object is expanded from the tightening state along the radial direction to be switched into an opening state, and the push-pull part is suitable for being pushed towards the far end of the pipe body or being pulled towards the near end of the pipe body to stretch the inner fixing object along the axial direction, so that the inner fixing object is contracted from the opening state to the tightening state along the radial direction. The device can meet the requirement of long-term use, is convenient to use, can achieve a very good sealing effect, is quick and convenient to replace, cannot cause secondary damage to the fistula, and the internal fixture does not need to be filled with water, so that the abdominal distention of a patient is avoided, and the experience feeling is good.

Description

A gastrostomy device

technical field

The invention relates to the technical field of ostomy, in particular to a gastrostomy device.

Background technique

Gastrostomy is a method in which a channel is established in the stomach wall and abdominal wall to deliver nutrients directly from the outside to the stomach. The passage between the stomach wall and the abdominal wall requires the insertion of a tube, so a gastrostomy device is often called a gastrostomy tube.

Clinically common gastrostomy tubes are usually divided into mushroom head and balloon type. The mushroom head gastrostomy tube is used for primary gastrostomy and is pulled from the stomach to the outside. The mushroom head structure can be fixed on the inner wall of the stomach, but cannot Insert from the outer wall of the abdomen inward; therefore, when the gastrostomy tube needs to be replaced, a balloon gastrostomy tube is usually used. When the balloon of the balloon gastrostomy tube is not filled with liquid, it is in a wall-attached state, and the entire gastrostomy tube can be directly inserted into the gastrostomy tube. Insert the fistula tract, and then fill the balloon with water. The inflated balloon can fix the inner wall of the stomach, and the outer wall of the abdomen is fixed with an external fixation pad. Although the balloon gastrostomy tube can be easily inserted into the fistula from the outer abdominal wall, there are still some problems:

1. The material of the balloon is usually silicone rubber, which is difficult to withstand the acidity of gastric juice and is easily corroded, resulting in trachoma and water leakage on the balloon skin, which cannot be used for a long time;

2. After the balloon is filled with water, the water content is large, causing a feeling of bloating in the stomach, and the patient's experience is poor.

Contents of the invention

The present invention aims to solve at least one of the technical problems existing in the prior art. For this reason, the present invention proposes a gastrostomy device, which can be used for a long time and is easy to replace, has no bulging feeling and has a good experience.

A gastrostomy device according to an embodiment of the present invention, comprising: a tubular body extending axially from the proximal end to the distal end; a joint disposed at the proximal end of the tubular body; an external fixing pad disposed on the tubular body Above, the distal end of the external fixation pad is suitable for fitting in contact with the outer wall of the abdomen; the internal fixation is arranged at the distal end of the tube body, and the internal fixation is at least partly braided by shape memory alloy wire. The internal fixation is adapted to be constrained by the constricting object into a tightened state. When the constricting object is released, the internal fixation is radially expanded from the tightened state to switch to a stretched state. The shape memory alloy The wire is folded from the distal edge of the tube body and extends to the inside of the tube body and forms a push-pull part inside the tube body, and the push-pull part is suitable for being pushed toward the distal end of the tube body or toward The proximal end of the tubular body is pulled to stretch the internal fixation in the axial direction, so that the internal fixation shrinks radially from a stretched state to a tightened state.

It has at least the following beneficial effects: the internal fixation of the device is at least partly braided by shape memory alloy wire, the shape memory alloy wire can be preformed into a desired shape, and is set to have a stable shape fixing effect at the temperature of the human body, It also has good acid resistance and corrosion resistance, which can meet the requirements of long-term use. This device is easy to use. The internal fixation is restrained into a tightened state through the constricting object, which is convenient for inserting into the inner wall of the stomach from the outer wall of the abdomen, and then released Constrained by the bundle, the internal fixation changes from a tightened state to a radial expansion to a stretched state, so that the internal fixation can cooperate with the external fixation pad to be respectively fixed on the inner wall of the stomach and the outer wall of the abdomen, achieving a very good sealing effect , nutrients can be directly transported from the outside to the stomach through the joint and the tube body. When the device needs to be replaced, since the shape memory alloy wire is folded from the distal edge of the tube body and extends to the inside of the tube body to form a push-pull part, it can Pushing toward the distal end of the tube body or pulling the push-pull part toward the proximal end of the tube body, by stretching the internal fixation in the axial direction, the internal fixation is shrunk radially from the stretched state to the tightened state, so that it can be smoothly The device can be easily taken out, the replacement is quick and convenient, no secondary damage to the fistula will be caused, and the internal fixation does not need to be filled with water, and the patient has no feeling of bloating in the abdomen, and the experience is good.

According to some embodiments of the present invention, the internal fixation includes a plurality of silicone skins arranged outside the tube, and the plurality of silicone skins are connected to the shape memory alloy wire. When the internal fixation is stretched In the normal state, a plurality of the silicone skins are respectively deployed along the radial direction, and the silicone skins are suitable for fitting and contacting the inner wall of the stomach.

According to some embodiments of the present invention, the outer body of the tube is wrapped with a silicone leather tube, and the distal area of the silicone tube close to the tube body is divided into a plurality of silicone skins along the circumference. When the fixation is in the tightened state, the plurality of silicone skins jointly wrap the shape memory alloy wire; when the internal fixation is in the stretched state, the plurality of silicone skins respectively follow the shape memory alloy wire along the Expand radially.

According to some embodiments of the present invention, the radial diameter of the internal fixation in the expanded state is larger than the axial diameter, and the internal fixation is oblate spherical in the expanded state.

According to some embodiments of the present invention, the constricting object is a sheath sleeved on the internal fixation object and the outer body of the tube, the proximal end of the sheath is suitable for extending out of the outer abdominal wall, and the sheath The tubular body is detachably connected only at the region extending beyond the outer abdominal wall.

According to some embodiments of the present invention, the area where the sheath extends out of the outer abdominal wall is a tearable sheath and is provided with a tear starting point and a tear end point, and the tear start point is connected to the tubular body. After the tearable sheath is torn, the sheath can be slid out relative to the internal fixation and the tubular body to release the constraint on the internal fixation.

According to some embodiments of the present invention, the constricting object is a string, the string is wrapped around the internal fixation to constrain the internal fixation in a tightened state, and the string is suitable for extending out of the internal fixation. The external wall of the abdomen is fastened, and the string is suitable for releasing the restraint of the internal fixation after being untied.

According to some embodiments of the present invention, the string extends from the inside of the tubular body outward to the outer abdominal wall, and the string can be pulled out from the tubular body after being untied.

According to some embodiments of the present invention, the tube body is suitable for inserting an inner support tube or an inner support rod, and the inner support tube or the inner support rod can push the push-pull part toward the distal end of the tube body to move along the Stretching the internal fixation in the axial direction makes the internal fixation shrink radially from a stretched state to a tightened state.

According to some embodiments of the present invention, the push-pull part is connected with a puller wire, and the puller wire extends from the inside of the tubular body outward to the outer wall of the abdomen, and the puller wire can be directed toward the proximal end of the tubular body The push-pull part is pulled to stretch the internal fixation in the axial direction, so that the internal fixation shrinks in the radial direction from the stretched state to the tightened state.

According to some embodiments of the present invention, the external fixation pad includes an abdominal wall contact surface connected in sequence from the distal end to the proximal end, an elastic part and a fixing part, the fixing part is fixedly connected with the tubular body, and the abdominal wall contact surface It is suitable for fitting and contacting the outer wall of the abdomen, and the elastic portion can elastically expand and contract in the axial direction.

According to some embodiments of the present invention, the shape memory alloy wire is a nickel-titanium alloy wire.

Additional aspects and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.

Description of drawings

The present invention will be further described below in conjunction with accompanying drawing and embodiment, wherein:

Fig. 1 is a schematic diagram of cooperation between an embodiment of the present invention and the inner wall of the stomach and the outer wall of the abdomen;

Fig. 2 is a schematic structural view of the internal fixation in a stretched state in some embodiments of the present invention;

Fig. 3 is a schematic structural view of internal fixation in a tightened state in some embodiments of the present invention;

Fig. 4 is a schematic structural view of the internal fixation in a stretched state in another part of the embodiment of the present invention;

Fig. 5 is a side view of Fig. 4;

Fig. 6 is a schematic diagram of the structure of the constrictor during the unconstraint process in some embodiments of the present invention;

Fig. 7 is a schematic diagram of the structure of Fig. 6 after hiding the constrictor;

Fig. 8 is a schematic diagram of the structure of the constrictor when constraining the internal fixation in another part of the embodiment of the present invention;

Fig. 9 is a schematic diagram of the structure of the constriction object after the constraint is released in another part of the embodiment of the present invention;

Fig. 10 is a schematic diagram of cooperation between the push-pull part and the inner support cylinder in the embodiment of the present invention;

Figure 11 is a schematic diagram of cooperation between the push-pull part and the inner strut in the embodiment of the present invention;

Fig. 12 is a schematic diagram of cooperation between the push-pull part and the pull wire in the embodiment of the present invention;

Fig. 13 is a schematic diagram of cooperation of some embodiments of the present invention with the inner wall of the stomach and the outer wall of the abdomen.

Reference numerals: tube body 1, joint 2, external fixing pad 3, abdominal wall contact surface 31, elastic part 32, fixing part 33, internal fixation object 4, shape memory alloy wire 41, silicone skin 42, silicone leather tube 43, Bundle 5, sheath tube 5a, tearable sheath tube 51a, tear starting point 511a, tear end point 512a, rope 5b, push-pull part 6, abdominal outer wall 7, stomach inner wall 8, inner support tube 9a, inner support rod 9b , pull line 9c.

Detailed ways

Embodiments of the present invention are described in detail below, examples of which are shown in the drawings, wherein the same or similar reference numerals designate the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by referring to the figures are exemplary only for explaining the present invention and should not be construed as limiting the present invention.

In the description of the present invention, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, near end, far end, etc. indicate the orientation or positional relationship based on the orientation shown in the drawings Or positional relationship is only for the convenience of describing the present invention and simplifying the description, but does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

In the description of the present invention, unless otherwise clearly defined, words such as setting, installation, and connection should be understood in a broad sense, and those skilled in the art can reasonably determine the specific meanings of the above words in the present invention in combination with the specific content of the technical solution.

Referring to FIGS. 1 to 13 , the present invention discloses a gastrostomy device, which includes a tube body 1 , a joint 2 , an external fixation pad 3 and an internal fixation 4 .

Wherein, the tube body 1 extends axially from the proximal end to the distal end, the joint 2 is arranged at the proximal end of the tube body 1, the joint 2 is used for accessing nutrients, the tube body 1 is used for transporting the nutrients into the stomach, and the external fixation The pad 3 is arranged on the tubular body 1 , and the distal end of the external fixation pad 3 is adapted to fit and contact the outer abdominal wall 7 .

Referring to Figures 1 to 9, the internal fixation 4 is arranged at the distal end of the tubular body 1, the internal fixation 4 is at least partially braided by a shape memory alloy wire 41, and the internal fixation 4 is suitable for being constrained by the constricting object 5 to form a constricted shape. In the tight state, when the restraint 5 is released, the internal fixator 4 expands radially from the tightened state to switch to the stretched state.

10 to 12, the shape memory alloy wire 41 is folded from the distal edge of the tube body 1 and extends to the inside of the tube body 1 and forms a push-pull part 6 inside the tube body 1. The push-pull part 6 is suitable for facing the tube body 1 The distal end of the tubular body 1 is pushed or pulled toward the proximal end of the tubular body 1 to stretch the internal fixation 4 in the axial direction, so that the internal fixation 4 shrinks radially from the stretched state to the tightened state.

It can be understood that the shape memory alloy wire 41 can be preformed into a desired shape, and is set to have a stable shape fixing effect at the temperature of the human body, and also has good acid resistance and corrosion resistance, which can meet the requirements of long-term use. Require.

This device is easy to use, and the internal fixation 4 is constrained into a tightened state by the binding object 5, so that it is convenient to insert the inner wall 8 of the stomach from the outer abdominal wall 7 inwardly, and then the restraint of the binding object 5 is released, and the internal fixation 4 is released from the tightened state. Expand in the radial direction to switch to a stretched state, so that the internal fixation 4 can cooperate with the external fixation pad 3 to be respectively fixed on the inner wall 8 of the stomach and the outer wall 7 of the abdomen to achieve a very good sealing effect, and nutrients can pass through the joint 2 and the tube. Body 1 is delivered directly into the stomach from the outside.

When the device needs to be replaced, since the shape memory alloy wire 41 is folded from the distal edge of the tube body 1 and extends to the inside of the tube body to form a push-pull part 6, it can be pushed toward the distal end of the tube body 1 or toward the bottom of the tube body 1. The proximal end pulls the push-pull part 6, and by stretching the internal fixation 4 in the axial direction, the internal fixation 4 shrinks radially from the stretched state to the tightened state, so that the device can be taken out smoothly.

The replacement of the device is fast and convenient, and will not cause secondary damage to the fistula, and the internal fixation 4 does not need to be filled with water, and the patient has no feeling of swelling in the abdomen, and the experience is good.

Considering that the balloon in the prior art usually bulges into a spherical shape, the contact surface with the stomach inner wall 8 is limited, and the sealing and fixation effect is not good, the present invention provides the following two types of embodiments for the shape of the internal fixation 4:

In some embodiments of the present invention, referring to FIG. 2 , the internal fixture 4 is roughly claw-shaped when it is in a stretched state. The internal fixture 4 includes a plurality of silicone skins 42 arranged outside the tube body. The multiple silicone skins 42 are in the same shape as The memory alloy wire 41 is connected. When the internal fixation 4 is stretched, a plurality of silicone skins 42 are spread out in the radial direction. The silicone skins 42 are suitable for fitting and contacting the inner wall 8 of the stomach, and the contact area with the inner wall 8 of the stomach is relatively large. , good sealing effect.

Further referring to FIG. 3 , the tube body 1 is wrapped with a silicone rubber tube 43, and the distal area of the silicone tube 43 close to the tube body 1 is divided into a plurality of silicone skins 42 along the circumference, and the silicone tube 43 plays a role of connecting and converging The function of multiple silicone skins 42, when the internal fixation 4 is in the tightened state, the multiple silicone skins 42 jointly wrap the shape memory alloy wire 41, and when the internal fixation 4 is in the stretched state, the multiple silicone skins 42 respectively follow The shape memory alloy wire 41 expands radially.

It can be understood that the silicone skin 42 has good elasticity and tissue affinity, and is very suitable for direct contact with the stomach inner wall 8. Even after the silicone skin 42 is corroded and ruptured, the shape memory alloy wire 41 can still continue to fix the stomach inner wall 8 The role will not fall off easily.

In some other embodiments of the present invention, referring to Fig. 4 and Fig. 5 , the radial diameter of the internal fixation 4 is larger than the axial diameter in the stretched state, and the internal fixation 4 is oblate spherical in the stretched state, and the internal fixation The object 4 can increase the contact area with the stomach inner wall 8, and improve the sealing and fixing effect.

Certainly, the form of the internal fixation object 4 of the present invention is not limited to the above two types of embodiments.

The present invention provides the following two types of embodiments for the bundle 5:

Referring to Fig. 6 and Fig. 7, in some embodiments of the present invention, the constricting object 5 is a sheath tube 5a set outside the internal fixture 4 and the tubular body 1, and the proximal end of the sheath tube 5a is suitable for extending out of the external abdominal wall 7 , the sheath tube 5a is detachably connected to the tubular body 1 only in the area extending out of the outer abdominal wall 7 .

Specifically, the area where the sheath tube 5a extends out of the abdominal wall 7 is a tearable sheath tube 51a and is provided with a tear starting point 511a and a tear end point 512a. The tear start point 511a is connected to the tubular body 1. When the tearable sheath tube 51a After being torn, the sheath 5a can be slid out relative to the internal fixation 4 and the tubular body 1 to release the constraint on the internal fixation 4 . That is to say, when the tearable sheath tube 51a is not torn, it plays the role of fixing the relative position of the sheath tube 5a and the tube body 1, and there is no need to tear the sheath tube 5a completely, especially the opening between the sheath tube 5a and the fistula opening. The contact area does not need to be torn, so as to avoid secondary damage to the fistula after all torn.

Referring to Fig. 8 and Fig. 9, in some other embodiments of the present invention, the constricting object 5 is a rope 5b, and the rope 5b is tightly wrapped around the internal fixture 4 to constrain the internal fixture 4 into a tightened state, and the rope 5b It is suitable for extending out of the outer abdominal wall 7 and fastening it. After untied, the string 5b is suitable for releasing the constraint on the internal fixation object 4 , and the operation is very convenient.

In order to avoid secondary injury caused by the string 5b to the fistula, the string 5b extends from the inside of the tubular body 1 to the outer abdominal wall 7, and the string 5b can be pulled out from the tubular body 1 after being untied.

Referring to FIG. 10 and FIG. 11 , in some embodiments, the inner support tube 9 a or the inner support rod 9 b is suitable for inserting into the tube body 1 , and the inner support tube 9 a or the inner support rod 9 b can push the push-pull part toward the distal end of the tube body 1 6. Stretch the internal fixation 4 in the axial direction, so that the internal fixation 4 shrinks radially from the stretched state to the tightened state, so that the device can be taken out from the fistula and reduce the damage to the fistula.

Referring to FIG. 12 , in some other embodiments, the push-pull part 6 is connected with a puller wire 9c, and the puller wire 9c extends from the inside of the tube body 1 to the outer abdominal wall 7, and the puller wire 9c can be pulled toward the proximal end of the tube body 1. Part 6 is used to stretch the internal fixation 4 in the axial direction, so that the internal fixation 4 shrinks radially from the stretched state to the tightened state, so that the device can be taken out from the fistula, reducing the damage to the fistula, and at the same time Prevent the push-pull part 6 from being exposed to the outside of the tube body 1 .

Referring to Fig. 13, the tightness of the traditional external fixation pad cannot be adjusted, and the tightness cannot be automatically adjusted with the natural expansion and contraction of the outer abdominal wall 7, and the sealing and fixation effect is poor. In some embodiments of the present invention, the external fixation pad 3 includes The abdominal wall contact surface 31, the elastic part 32 and the fixed part 33 connected in sequence to the proximal end, the fixed part 33 is fixedly connected with the tube body 1, the abdominal wall contact surface 31 is suitable for fitting and contacting the outer abdominal wall 7, and the elastic part 32 can be elastic along the axial direction Stretchable, so that the external fixation pad 3 has the function of automatically adjusting the tightness, and the contact surface 31 of the abdominal wall can expand and contract with the natural expansion and contraction of the outer abdominal wall 7, and the patient experience is good.

In some embodiments of the present invention, the shape-memory alloy wire 41 can specifically be a nickel-titanium alloy wire. The nickel-titanium alloy wire has very good acid resistance, can withstand gastric acid environment for a long time, prolongs the service life of the device, and prevents shape memory The alloy wire 41 is corroded by gastric acid and falls off.

The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.

Of course, the present invention is not limited to the above-mentioned embodiments. Those skilled in the art can also make equivalent modifications or replacements without departing from the spirit of the present invention. These equivalent modifications or replacements are all included in the claims of the present application. In the range.

Claims (12)

1. A gastrostomy device, comprising:

a tube extending axially from a proximal end to a distal end;

the joint is arranged at the near end of the tube body;

the outer fixing pad is arranged on the tube body, and the far end of the outer fixing pad is suitable for being attached to and contacted with the outer wall of the abdomen;

the inner fixing object is arranged at the far end of the pipe body and is at least partially woven by shape memory alloy wires, the inner fixing object is suitable for being restrained into a tightened state by a restrained object, when the restrained object is relieved, the inner fixing object is expanded from the tightened state in the radial direction to be switched into a spread state, the shape memory alloy wires are folded and extended to the inside of the pipe body from the far end edge of the pipe body, a push-pull part is formed in the inside of the pipe body, the push-pull part is suitable for being pushed towards the far end of the pipe body or being pulled towards the near end of the pipe body to stretch the inner fixing object in the axial direction, and the inner fixing object is contracted from the spread state to the tightened state in the radial direction.

2. The gastrostomy device according to claim 1, wherein the internal fixation comprises a plurality of silicone skins arranged outside the tube body, the plurality of silicone skins are connected with the shape memory alloy wire, when the internal fixation is in a stretched state, the plurality of silicone skins are respectively unfolded in a radial direction, and the silicone skins are suitable for being attached to and contacted with the inner wall of the stomach.

3. The gastrostomy device according to claim 2, wherein the tube body is wrapped with a silicone rubber tube, a distal end region of the silicone rubber tube close to the tube body is circumferentially divided into a plurality of silicone rubbers, the plurality of silicone rubbers wrap the shape memory alloy wire together when the inner fixture is in a tightened state, and the plurality of silicone rubbers respectively follow the shape memory alloy wire to expand in a radial direction when the inner fixture is in a spread state.

4. The gastrostomy device according to claim 1, wherein the radial diameter of the internal anchor in the expanded state is greater than the axial diameter, the internal anchor being oblate spheroid in the expanded state.

5. The gastrostomy device according to claim 1, wherein the constriction is a sheath which is sleeved outside the inner fixation object and the tube body, the proximal end of the sheath is adapted to extend out of the abdominal outer wall, and the sheath is detachably connected with the tube body only in the region where the sheath extends out of the abdominal outer wall.

6. The gastrostomy device according to claim 5, wherein the region of the sheath extending out of the abdominal outer wall is a tearable sheath and is provided with a tear start point and a tear end point, the tear start point is connected with the tube body, and when the tearable sheath is torn, the sheath can be slidingly removed relative to the inner fixture and the tube body to release the constraint on the inner fixture.

7. The gastrostomy device of claim 1, wherein the constriction is a string which is wrapped around the inner fixation to constrain the inner fixation in a constricted state, the string being adapted to extend out of the outer abdominal wall and be tied, the string being adapted to be unwrapped from constraint on the inner fixation after being unwrapped.

8. The gastrostomy device according to claim 7, wherein the string extends from the interior of the tube outwardly beyond the abdominal outer wall, the string being extractable from the tube after unwinding.

9. The gastrostomy device according to claim 1, wherein said tube body is adapted to have an internal support tube or rod inserted therein, said internal support tube or rod pushing said push-pull portion towards the distal end of said tube body to axially stretch said internal anchor, causing said internal anchor to radially contract from the expanded state to the contracted state.

10. The gastrostomy device according to claim 1, wherein a pull wire is connected to the push-pull portion, the pull wire extending outwardly from the interior of the tube body beyond the outer abdominal wall, the pull wire being capable of pulling the push-pull portion towards the proximal end of the tube body to axially stretch the inner fixation, causing the inner fixation to radially contract from the expanded state to the contracted state.

11. The gastrostomy device according to claim 1, wherein the external fixing pad comprises an abdominal wall contact surface, a tightening part and a fixing part which are sequentially connected from the far end to the near end, the fixing part is fixedly connected with the tube body, the abdominal wall contact surface is suitable for being in fit contact with the abdominal outer wall, and the tightening part can elastically stretch and retract along the axial direction.

12. A gastrostomy device according to any one of claims 1 to 11, wherein the shape memory alloy wire is nitinol.

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