JP7518486B2 - Subcutaneously implantable port and method for manufacturing the same - Google Patents

Description

The present invention relates to a subcutaneously implantable port for injecting medicinal fluids, which is used in the medical field by being implanted under the skin of a patient and is used to inject medicinal fluids into the body.

When performing treatments that require repeated injections of medicinal fluids into the body over a long period of time, it has been considered to implant a port for injecting medicinal fluids subcutaneously in the patient's skin to reduce the burden on the body caused by repeated punctures.

As shown in, for example, JP 6-277298 A (Patent Document 1), such a subcutaneously implantable port for injecting drug solutions has a structure in which the opening of the housing is blocked with an elastic body to form an internal cavity for storing drug solutions. The drug solution is then injected into the internal cavity by a needle that penetrates the skin and punctures the elastic body, and is then guided through a drug solution outflow flow path provided on the outer periphery of the housing and further through a catheter or the like into an internal lumen such as a blood vessel for injection.

In the subcutaneously implantable port of the conventional structure described in the above-mentioned Patent Document 1, a groove (9) is formed on the underside of the elastic body (sealing body 1), and a ridge (10) is formed on the housing (main body 3), and the ridge is inserted into the groove. This can prevent the elastic body from slipping down into the lumen when the needle is pierced into the elastic body.

However, because the ridges are funnel-shaped and gradually widen upward, gaps (see the boxed area in Figure 15 of the present application, which shows Figure 1 of Patent Document 1) tend to form between the elastic body and the housing, causing the drug solution to stagnate. This can lead to the proliferation of bacteria, which can cause infections or block the port.

Japanese Patent Application Publication No. 6-277298

The present invention was made against the background of the above circumstances, and the problem to be solved by the present invention is to provide a subcutaneously implantable port with a novel structure that can prevent or reduce the gap between the elastic body and the housing, and a method for manufacturing the novel subcutaneously implantable port.

A first aspect of the present invention is a subcutaneously implantable port comprising an elastic body and a housing which is assembled so as to compress the elastic body in its thickness direction, the opening of the housing being blocked by the elastic body to form an inner cavity for storing a medicinal solution, the inner surface of the elastic body prior to assembly into the housing being formed with an annular surface protruding toward the inner surface and a recess located on the inner side of the annular surface, while the housing has a compression retaining portion facing the annular surface of the elastic body for compressing an outer circumferential portion of the annular surface in the thickness direction during assembly, and compression in the compression retaining portion causes the inner circumferential portion of the annular surface of the elastic body to change direction toward the outer circumferential side, with at least a portion of it overlapping the inner surface of the compression retaining portion.

According to the subcutaneously implantable port constructed according to this embodiment, the outer peripheral portion of the annular surface on the inner surface of the elastic body is compressed in the thickness direction by the compression retaining portion of the housing, so that the outer peripheral portion of the inner surface of the elastic body is deformed upward. The deformation caused by the compression retaining portion is likely to occur in the inner peripheral portion of the annular surface, but is unlikely to occur in the recessed portion. The inner peripheral portion of the annular surface is likely to deform significantly because of the recessed portion on the inside, and is likely to deform toward the compression retaining portion following the outer peripheral portion of the annular surface. Therefore, the inner peripheral portion of the annular surface deforms to fill the gap caused by compression by the compression retaining portion, so that the gap between the compression retaining portion and the elastic body due to compression can be made smaller than in the past. Specifically, the inner peripheral portion of the annular surface changes direction and overlaps with the inner peripheral surface of the compression retaining portion, so that the generation of a gap between the elastic body and the housing in a direction perpendicular to the thickness direction of the elastic body is avoided, or even if a gap occurs, the size of the gap is kept small. This can avoid or suppress retention of the drug solution in the lumen.
In a second aspect of the present invention, in the subcutaneously implantable port according to the first aspect, an upper end surface of the compression retaining portion is formed as a flat surface.
In a third aspect of the present invention, in the subcutaneously implantable port according to the first or second aspect, the housing is provided with a locking claw that locks onto the outer circumferential portion of the outer surface of the elastic body, and the protruding tip of the locking claw is located on the inner circumferential side of the compression retaining portion.
In a fourth aspect of the present invention, in the subcutaneously implantable port according to the third aspect, the housing is provided with an inner wall portion on the inner side of the compression retaining portion, the inner wall portion being lower in height than the compression retaining portion, and the inner wall portion faces the engaging claw.
In a fifth aspect of the present invention, in the subcutaneous implantable port according to the fourth aspect, the opposing distance between the locking claw and the inner wall portion of the housing in the thickness direction of the elastic body is greater than the opposing distance between the portion outer circumferentially further away than the locking claw and the compression retaining portion.
In a sixth aspect of the present invention, in the subcutaneously implantable port according to any one of the first to fifth aspects, the housing includes a tapered tubular portion having an inner diameter dimension that gradually decreases toward the top, the outer peripheral surface of the elastic body is superimposed on the inner peripheral surface of the tapered tubular portion, and the taper angle of the inner peripheral surface of the tapered tubular portion is made larger than the outer peripheral surface of the elastic body superimposed on the tapered tubular portion before assembly into the housing.

A seventh aspect of the present invention is a method for manufacturing a subcutaneously implantable port comprising an elastic body and a housing assembled so as to compress the elastic body in its thickness direction, the opening of the housing being blocked by the elastic body to form an inner cavity for storing a medicinal solution, wherein prior to assembly, the inner surface of the elastic body is formed with an annular surface protruding toward the inner surface and a recess located on the inner side of the annular surface, while the housing has a compression retaining portion facing the annular surface of the elastic body for compressing an outer peripheral portion of the annular surface in the thickness direction during assembly, and the compression retaining portion deforms the inner peripheral portion of the annular surface towards the compression retaining portion when the outer peripheral portion of the annular surface of the elastic body is compressed.

According to the manufacturing method of the subcutaneously implantable port of this embodiment, when the elastic body is assembled to the housing, the outer peripheral portion of the inner surface of the elastic body is compressed by the compression retaining portion of the housing, causing the outer peripheral portion of the inner surface of the elastic body to deform upward. Deformation caused by the compression retaining portion is likely to occur in the inner peripheral portion of the annular surface, but is unlikely to occur in the recessed portion. The inner peripheral portion of the annular surface is likely to deform significantly due to the presence of a recess on the inside, and is likely to deform toward the compression retaining portion in accordance with the outer peripheral portion of the annular surface. Therefore, the inner peripheral portion of the annular surface deforms to fill the gap caused by compression by the compression retaining portion, so that the gap between the compression retaining portion and the elastic body caused by compression can be made smaller than in the past. Therefore, the generation of a gap between the elastic body and the housing when the elastic body is assembled to the housing is avoided, or even if a gap occurs, its size can be reduced.

A subcutaneously implantable port constructed in accordance with the present invention can prevent or minimize the occurrence of gaps between the elastic body and the housing.

In addition, the method for manufacturing a subcutaneously implantable port according to the present invention makes it possible to assemble the elastic body to the housing while preventing or minimizing the occurrence of gaps between the elastic body and the housing.

1 is a perspective view of a subcutaneously implantable port according to one embodiment of the present invention; FIG. 2 is a bottom view of the subcutaneously implantable port shown in FIG. 1 . FIG. 3 is a cross-sectional view taken along line III-III in FIG. 2 is a perspective view showing a housing body constituting the subcutaneously implantable port shown in FIG. 1 in a separate state prior to assembly. FIG. FIG. 5 is a bottom view of the housing body shown in FIG. 4 . 6 is a cross-sectional view taken along line VI-VI in FIG. 5 . 2 is a perspective view showing a base member constituting the subcutaneously implantable port shown in FIG. 1 in a separate state prior to assembly. FIG. FIG. 8 is a longitudinal sectional view of the base member shown in FIG. 7 . 2 is a perspective view showing an elastic body constituting the subcutaneously implantable port shown in FIG. 1 in a separate state prior to assembly; FIG. 10 is a bottom view of the elastic body shown in FIG. 9 . 10A is a longitudinal sectional view of the elastic body shown in FIG. 9, and FIG. 10B is an enlarged view of a main portion of FIG. FIG. 2 is a diagram showing the internal structure of the subcutaneously implantable port shown in FIG. 1 actually manufactured, photographed by computed tomography. FIG. 2 is a longitudinal cross-sectional view showing the subcutaneously implantable port shown in FIG. 1 in use; 4 is a longitudinal cross-sectional view of a subcutaneously implantable port according to another embodiment of the present invention, the view corresponding to FIG. 3. FIG. 13 is a diagram illustrating a gap between an elastic body and a housing in a subcutaneously implantable port of a conventional structure.

In order to clarify the present invention more specifically, the following embodiment of the present invention will be described in detail with reference to the drawings.

1 to 3 show a subcutaneously implantable port 10 according to an embodiment of the present invention. An elastic body 16 is attached to the subcutaneously implantable port 10 so as to close an opening 14 provided in a housing 12. By closing the opening 14 of the housing 12 with the elastic body 16, a lumen 18 for storing a liquid medicine is formed inside the subcutaneously implantable port 10. A liquid medicine outlet flow channel 22 is formed in the peripheral wall 20 of the housing 12, penetrating the wall in the thickness direction and communicating with the lumen 18, so that the liquid medicine stored in the lumen 18 is injected into a lumen in the body, such as a blood vessel, through the liquid medicine outlet flow channel 22. In the following description, the vertical direction generally refers to the vertical direction in FIG. 3. The horizontal direction generally refers to a direction perpendicular to the vertical direction, for example, the left-right direction in FIG. 3.

More specifically, the housing 12 of this embodiment is made of hard synthetic resin and has a divided structure including a housing main body 24 shown in Figures 4 to 6 and a base member 26 shown in Figures 7 and 8.

The housing body 24 is generally cylindrical and gradually expands downwards, and has a peripheral wall 28 that extends continuously around the entire circumference, and a through hole 30 that penetrates the inner periphery of the peripheral wall 28 in the vertical direction.

The outer peripheral surface 32 of the peripheral wall 28 has an inclined surface 32a in the upper half with a constant inclination angle and a gradually decreasing outer diameter in the upward direction. In the lower half of the outer peripheral surface 32 of the peripheral wall 28, a portion of the circumference (the left portion in Figs. 5 and 6) is a vertical outer peripheral surface 32b that extends parallel to the up-down direction, and the remaining portion is a curved outer peripheral surface 32c whose inclination angle gradually changes and whose outer diameter gradually decreases in the upward direction.

On the other hand, the inner peripheral surface 34 of the peripheral wall 28 has an upper half formed as an inclined surface 34a with an inner diameter that gradually decreases upward at a substantially constant inclination angle, and an upper half formed as a vertical inner peripheral surface 34b with a substantially constant inner diameter that extends substantially straight in the vertical direction. In this embodiment, the outer peripheral surface 32 (inclined surface 32a) and the inner peripheral surface 34 (inclined surface 34a) in the upper half of the peripheral wall 28 are formed substantially parallel to each other.

That is, in this embodiment, the substantially upper half of the peripheral wall 28 is a tapered tube portion 36 that has a substantially constant thickness and a gradually decreasing diameter toward the top. In the substantially lower half of the peripheral wall 28, the portion that forms the curved outer peripheral surface 32c is a flared portion 38 that gradually increases in thickness toward the bottom, and the portion that forms the vertical outer peripheral surface 32b is a vertical wall portion 40 that has a substantially constant thickness and extends in the vertical direction.

Here, a notched side opening 42 is formed in the center of the width direction (vertical direction in FIG. 5) of the vertical wall portion 40, opening at the lower end surface and penetrating in the thickness direction. This side opening 42 is approximately rectangular, and the through hole 30 opens to the vertical outer peripheral surface 32b through the side opening 42. In this embodiment, a pair of fixed wall portions 44, 44 are provided at the lower end portion of the side opening 42, protruding horizontally outward (to the left in FIGS. 5 and 6) from the vertical outer peripheral surface 32b. A catheter 96, which will be described later, is locked to the port portion 88 via the fixed wall portions 44, 44.

These fixed walls 44, 44 are each substantially block-shaped. The fixed walls 44, 44 face each other in the width direction of the vertical wall 40, and are provided on both sides of the side opening 42, with the distance between the facing surfaces of the fixed walls 44, 44 being smaller than the opening width dimension of the side opening 42. In other words, the fixed walls 44, 44 protrude from both sides of the side opening 42 in a direction toward the inside of the side opening 42, and in this embodiment, the opening width dimension of the side opening 42 from the through hole 30 to the outside is reduced at the position where the fixed walls 44, 44 are formed.

In particular, in this embodiment, a rib-like protrusion 46 that protrudes outward in the opposing direction of the fixed walls 44, 44 (the width direction of the vertical wall 40) is formed at the protruding tip of each fixed wall 44 (the left end in Figs. 5 and 6). That is, the width dimension (vertical dimension in Fig. 5) of the fixed wall 44 is made larger at the position where the rib-like protrusion 46 is formed at the protruding tip of the fixed wall 44 than at other parts.

The upper opening of the peripheral wall 28 is provided with a generally annular inner flange portion 48 that protrudes inward. That is, the inner diameter of the peripheral wall 28 is generally constant in the vertical direction at the position where the vertical inner surface 34b is formed, but gradually becomes smaller toward the top at the position where the inclined surface 34a is formed, and becomes even smaller at the position where the inner flange portion 48 is formed. In this embodiment, the upper opening of the peripheral wall 28 constitutes the opening 14 of the housing 12.

Furthermore, in this embodiment, a generally annular locking claw 50 is formed at the inner peripheral edge (protruding tip) of the inner peripheral flange portion 48 and protrudes downward. In particular, in this embodiment, the protruding tip (lower end) of the locking claw 50 is formed in a tapered shape.

On the other hand, the lower end surface 52 of the peripheral wall 28, i.e., the lower end surface 52 of the flared portion 38, is a generally annular flat surface that spreads horizontally and has a through hole 30 in the center. A generally annular groove 54 that opens downward at the approximate center is formed generally coaxially with the through hole 30 on the lower end surface 52 and communicates with the through hole 30. The inner diameter of this annular groove 54 is larger than the inner diameter of the rest of the through hole 30; that is, the inner diameter of the through hole 30 is larger at the position where the annular groove 54, which is the lower opening, is formed than the rest of the through hole 30.

In addition, in the lower part of the peripheral wall 28, i.e., in the flare-shaped portion 38, substantially circular through holes 56 that penetrate in the vertical direction are formed on both sides of the vertical wall portion 40 in the circumferential direction. That is, the upper end of the through hole 56 opens on the outer peripheral surface 32 (curved outer peripheral surface 32c) of the flare-shaped portion 38, and the lower end opens on the lower end surface 52 of the flare-shaped portion 38. Then, in the lower end surface 52 of the flare-shaped portion 38, the annular groove 54 and the through hole 56 are connected to each other by a fitting groove 58 that opens downward. That is, in this embodiment, the fitting groove 58 is substantially rectangular, and is formed on both sides of the circumferential direction of the side opening 42 in the lower end surface 52 of the flare-shaped portion 38. In addition, in this embodiment, the groove depth dimension (vertical dimension) of the fitting groove 58 is smaller than the groove depth dimension of the annular groove 54.

On the other hand, the base member 26 of this embodiment has an overall cylindrical shape with a bottom, and includes a peripheral wall portion 60 that extends continuously around the entire circumference, and a bottom wall portion 62 that is approximately disk-shaped and covers the lower opening of the peripheral wall portion 60. That is, the bottom wall portion 62 has an upper end surface 63a and a lower end surface 63b that are both approximately circular, and the peripheral wall portion 60 is provided to protrude upward from the upper end surface 63a of the bottom wall portion 62. The peripheral wall portion 60 and the bottom wall portion 62 form a central recess 64 that has the upper end surface 63a of the bottom wall portion 62 as its bottom surface and opens upward.

Here, an inner peripheral wall portion 66 is formed on the inner peripheral side of the peripheral wall portion 60, which extends continuously over almost the entire circumference in the circumferential direction. This inner peripheral wall portion 66 is provided by thickening the inner peripheral side of the peripheral wall portion 60. In other words, the inner peripheral wall portion 66 is provided by protruding from the inner peripheral surface 68 of the peripheral wall portion 60 to the inner peripheral side. The vertical dimension (height dimension) of the inner peripheral wall portion 66 is smaller than the vertical dimension of the peripheral wall portion 60, and the upper end surface 70 of the inner peripheral wall portion 66 is located below the upper end surface 72 of the peripheral wall portion 60. In other words, the upper end surface 70 of the inner peripheral wall portion 66 is located below the upper end surface 72 of the peripheral wall portion 60, sandwiching a step-shaped portion, and the step-shaped portion is formed by the inner peripheral surface 68 of the peripheral wall portion 60.

That is, the inner surface of the central recess 64 includes the inner circumferential surface of the inner wall portion 66 and the upper end surface 63a of the bottom wall portion 62, and in this embodiment, the inner circumferential surface of the inner wall portion 66 and the upper end surface 63a of the bottom wall portion 62 are connected by a curved surface 74 that gradually curves inwardly downward. Therefore, the inner diameter dimension of the central recess 64 gradually increases from the bottom surface of the central recess 64 (the upper end surface 63a of the bottom wall portion 62) upward, and is approximately constant at the inner circumferential surface of the inner wall portion 66, and is further increased at the position where the step-shaped portion 68 is formed, and is approximately constant with the inner diameter dimension of the peripheral wall portion 60.

In this embodiment, the inner diameter dimension φα (see FIG. 8) of the inner wall portion 66, i.e., the inner diameter dimension φα at the upper end surface 70 of the inner wall portion 66, is approximately equal to or larger than the inner diameter dimension φβ (see FIG. 6) at the opening 14 of the housing 12, i.e., the inner diameter dimension φβ at the inner flange portion 48 of the housing body 24, and in this embodiment, the inner diameter dimension φα at the upper end surface 70 of the inner wall portion 66 and the inner diameter dimension φβ at the opening 14 of the housing 12 are approximately equal (φα ≒ φβ).

On the other hand, an outer peripheral flange portion 76 is formed from the lower end portion of the outer peripheral surface of the peripheral wall portion 60, protruding outward. That is, the outer diameter dimension of the peripheral wall portion 60 is larger at the position where the outer peripheral flange portion 76 is formed than other portions. The outer diameter dimension of the peripheral wall portion 60 is approximately equal to or slightly smaller than the inner diameter dimension of the flare-shaped portion 38 and the vertical wall portion 40 in the housing main body 24 (i.e., the inner diameter dimension at the vertical inner peripheral surface 34b, which has an approximately constant inner diameter dimension at the inner peripheral surface 34 of the peripheral wall 28), and the outer diameter dimension of the outer peripheral flange portion 76 is approximately equal to or slightly smaller than the inner diameter dimension of the annular groove 54 at the lower end surface 52 of the housing main body 24.

In addition, an outer peripheral protrusion 78 is formed on the outer peripheral surface of the peripheral wall portion 60 from a part of the circumference (left side in FIG. 8) that protrudes outward. This outer peripheral protrusion 78 is generally formed in a substantially rectangular parallelepiped shape, and has a shape that substantially corresponds to the side opening 42 in the vertical wall portion 40 of the housing body 24. Furthermore, a storage recess 80 that opens outward is formed on the outer peripheral surface of the outer peripheral protrusion 78. This storage recess 80 has a substantially circular cross section and extends in the horizontal direction, penetrating the outer peripheral protrusion 78 and the peripheral wall portion 60, and the bottom surface of the storage recess 80 reaches the radial middle portion of the inner peripheral wall portion 66. And, a communication hole 82 that penetrates the inner peripheral wall portion 66 in the thickness direction (radial direction) is formed on the bottom surface of the storage recess 80. That is, one end of the communication hole 82 in the length direction opens into the bottom surface of the accommodation recess 80, and the other end of the communication hole 82 in the length direction opens into the curved surface 74 of the central recess 64, and the accommodation recess 80 and the central recess 64 are connected by the communication hole 82. The outer peripheral opening of the accommodation recess 80 has a larger inner diameter than the other parts, that is, the outer peripheral opening of the accommodation recess 80 has an annular step surface 84 that expands in the vertical direction.

Furthermore, the outer peripheral flange portion 76 is provided with fitting plate portions 86 that protrude outward on both sides of the outer peripheral projection 78. The fitting plate portions 86 are generally rectangular in shape and generally correspond to the fitting grooves 58 provided in the lower end surface 52 of the housing body 24. In this embodiment, the lower end surface 87 of the base member 26 is configured to include the lower end surface 63b of the bottom wall portion 62, the lower end surface of the outer peripheral flange portion 76, the lower end surface of the outer peripheral projection 78, and the lower end surfaces of the fitting plate portions 86, 86, and each of the lower end surfaces is a continuous flat surface without any steps.

A port member 90 having a port portion 88 is attached to the housing recess 80 of the base member 26. The port member 90 is generally cylindrical and extends horizontally, with a central hole 92 that penetrates in the length direction and has a generally constant inner diameter. One side of the port member 90 in the length direction is a large diameter portion 94 with a large outer diameter, and the other side of the length direction is a small diameter portion with a small outer diameter.

The large diameter portion 94 is inserted into the accommodation recess 80 and, if necessary, is pressed in or glued or welded, etc., so that the port member 90 is fixed to the base member 26, and a part of the large diameter portion 94 and the small diameter portion protrude horizontally outward from the base member 26. However, the port member 90 may be attached to the base member 26 in a non-fixed manner, or, as described below, the port member 90 may be sandwiched between the base member 26 and the housing main body 24, and the base member 26 and the housing main body 24 may be fixed to each other, so that the port member 90 is fixed to the base member 26.

Furthermore, an external conduit, for example, a catheter 96 (shown by a two-dot chain line in FIG. 3) is fitted onto the small diameter portion that protrudes horizontally outward from the base member 26, i.e., the port portion 88 to which the external conduit is connected is formed by the small diameter portion on the other longitudinal side of the port member 90. The outer peripheral surface of the port portion 88 is provided with irregularities so that the catheter 96 fitted onto the port portion 88 will not easily come off. By embedding the subcutaneously implantable port 10 of this embodiment subcutaneously, the catheter 96 is connected to an internal lumen such as a blood vessel.

In addition, a generally annular engagement protrusion 98 is formed on the outer peripheral surface of the large diameter portion 94 at the longitudinal middle portion, and when the port member 90 is inserted into the accommodating recess 80, the engagement protrusion 98 comes into contact with a step surface 84 provided on the inner peripheral surface of the accommodating recess 80, thereby determining the amount of insertion of the port member 90 into the accommodating recess 80.

By inserting and fixing the port member 90 into the accommodation recess 80 of the base member 26 in this manner, the central hole 92 of the port member 90 and the communication hole 82 provided on the bottom surface of the accommodation recess 80 are mutually communicated. In other words, the central recess 64 of the base member 26 is communicated with the external space by the communication hole 82, the central hole 92, and the catheter 96. Therefore, as described below, the drug solution outflow flow path 22, which outflows the drug solution stored in the lumen 18 in the housing 12, is composed of these communication holes 82 and the central hole 92.

In this embodiment, for example, a pair of arms (not shown) protrude outward in the width direction (on both the top and bottom sides in FIG. 2) from the large diameter portion 94 of the port member 90, and a positioning protrusion 102 protruding upward is provided at the protruding tip 100 of the arms. The positioning protrusion 102 is a substantially circular protrusion that has a shape that substantially corresponds to the through hole 56 formed in the housing main body 24, and when the housing main body 24 and the base member 26 are assembled as described below, the positioning protrusion 102 fits into the through hole 56, and the housing main body 24 and the base member 26 are positioned relative to each other.

The housing 12 of this embodiment is constructed by assembling and fixing the housing main body 24 and base member 26 constructed as described above. The method of fixing the base member 26 and the housing main body 24 is not limited in any way, but in this embodiment, they are fixed by ultrasonic welding. In addition, the parts that are welded by ultrasonic welding are not limited in any way, but for example, the overlapping part between the annular groove 54 and the outer peripheral flange part 76, and the overlapping part between the side opening 42 and the outer peripheral protrusion 78, etc. can be fixed to each other by welding.

That is, the housing body 24 is overlapped from above on the base member 26 to which the port member 90 is assembled. As a result, the positioning protrusion 102 protruding upward from the protruding tip 100 of the arm of the port member 90 is fitted into the through hole 56 provided in the housing body 24. Also, the outer peripheral flange portion 76 of the base member 26 is fitted into the annular groove 54 provided in the lower end surface 52 of the housing body 24, and the fitting plate portion 86 of the base member 26 is fitted into the fitting groove 58. As a result, the positioning of the housing body 24 and the base member 26 is achieved to a high degree, and since the arm of the port member 90 is covered from below by the fitting plate portion 86, the positioning protrusion 102 can be effectively prevented from slipping out of the through hole 56. Furthermore, the bottom end surface 52 of the housing body 24 and the bottom end surface 87 of the base member 26 are smoothly connected without any steps, so that the subcutaneously implantable port 10 will not get caught on internal tissue when embedded in the body.

Furthermore, by inserting the outer peripheral protrusion 78 of the base member 26 into the side opening 42 provided in the vertical wall portion 40 of the housing main body 24, the outer peripheral surface of the large diameter portion 94 of the port member 90 is inserted while being substantially in contact with the opposing surfaces of the fixed wall portions 44, 44, and the engagement protrusion 98 protruding from the large diameter portion 94 to the outer peripheral side is sandwiched and fixed between the step surface 84 provided in the outer peripheral opening portion of the accommodation recess 80 and the fixed wall portions 44, 44 in the horizontal direction. This effectively prevents the port member 90 from tilting with respect to the housing main body 24 or the base member 26, or from falling off the housing main body 24 or the base member 26. In addition, since the port member 90 can be assembled to the base member 26 in a non-fixed manner, the assembly efficiency can also be improved.

By assembling the housing body 24 and the base member 26 together in this manner, the lower opening in the peripheral wall 28 of the housing body 24 is covered by the base member 26. That is, the peripheral wall portion 60 and the inner peripheral wall portion 66 of the base member 26 are inserted into the inner peripheral side of the peripheral wall 28 of the housing body 24. Therefore, the peripheral wall 20 of the housing 12 is partially formed by overlapping the peripheral wall 28 of the housing body 24 (particularly the flare-shaped portion 38 and the vertical wall portion 40) with the peripheral wall portion 60 and the inner peripheral wall portion 66 of the base member 26. In addition, the peripheral wall portion 60 of the base member 26 faces the inner peripheral flange portion 48 and the tapered tube portion 36 of the housing body 24 in the vertical direction, and the inner peripheral wall portion 66 of the base member 26 faces the protruding tip (inner peripheral edge portion) of the inner peripheral flange portion 48, that is, in this embodiment, the portion of the inner peripheral flange portion 48 where the locking claw 50 is formed, in the vertical direction.

The elastic body 16 shown in Figures 9, 10, 11(a), and (b) is assembled to the housing 12. That is, Figures 9, 10, 11(a), and (b) show the elastic body 16 in a separate state before being assembled to the housing 12. This elastic body 16 is made of an elastic material such as rubber or elastomer. In this embodiment, the elastic body 16 is generally thick and has a generally circular disk shape, and the thickness dimension of the elastic body 16 is in the vertical direction.

That is, the elastic body 16 has an upper surface 104 that becomes the outer surface when assembled to the housing 12, and a lower surface 106 that becomes the inner surface located on the inner cavity 18 side. In this embodiment, in the state of the elastic body 16 alone before being assembled to the housing 12, these upper surface 104 and lower surface 106 are made to be approximately circular with approximately the same diameter. In particular, in this embodiment, in the state of the elastic body 16 alone, the diameter dimensions of the upper surface 104 and the lower surface 106, i.e., the outer diameter dimension of the elastic body 16, are approximately equal to or slightly smaller than the outer diameter dimension of the peripheral wall portion 60 of the base member 26. In addition, in the state of the elastic body 16 alone, the vertical dimension of the elastic body 16, i.e., the vertical separation distance D1 (see FIG. 11(a)) between the upper surface 104 and the lower surface 106, is larger than the vertical separation distance D2 (see FIG. 3) between the peripheral wall portion 60 and the inner flange portion 48 when the housing main body 24 and the base member 26 are assembled, which will be described later. Furthermore, the vertical dimension D3 (see FIG. 11(a)) of the position where the circular recess 110 described below is formed when the elastic body 16 is in a standalone state is smaller than the maximum vertical dimension D4 (see FIG. 3) at the position where the circular recess 110 was formed when the elastic body 16 is assembled to the housing 12.

Here, the central portion of the upper surface 104 of the elastic body 16 is provided with a fitting protrusion 108 that protrudes toward the outer surface side, i.e., upward. In other words, a ring-shaped flat surface 109 is formed on the outer peripheral portion of the upper surface 104 of the elastic body 16, located below the fitting protrusion 108, and the upper surface 104 of the elastic body 16 is configured to include the upper end surface of the fitting protrusion 108 and the flat surface 109. The fitting protrusion 108 has a substantially flat cylindrical shape with an outer diameter dimension larger than its height dimension, and in this embodiment, the outer diameter dimension of the fitting protrusion 108 is substantially equal to or slightly smaller than the inner diameter dimension of the opening 14, i.e., the inner diameter dimension of the inner flange portion 48. In addition, by assembling the elastic body 16 to the housing 12, the upper end surface of the fitting protrusion 108 is positioned above the upper end surface of the housing 12, i.e., the upper end surface of the inner flange portion 48.

On the other hand, a circular recess 110 is formed in the center of the lower surface 106 of the elastic body 16 as a recess having a substantially circular shape that opens toward the inner surface, i.e., downward. In short, the circular recess 110 has a substantially circular upper bottom surface 112 located above the lower surface 106 of the elastic body 16, and an outer peripheral surface 114 that extends downward from the outer peripheral edge of the upper bottom surface 112 and is connected to the lower surface 106 of the elastic body 16. In this embodiment, the upper bottom surface 112 is a flat surface that is substantially parallel to the radial direction of the elastic body 16 (the left-right direction in FIG. 11), and the outer peripheral surface 114 is a smoothly curved surface in which the inner diameter dimension of the outer peripheral surface 114 gradually increases toward the bottom. Note that the upper bottom surface 112 does not necessarily have to be a flat surface, and may be uneven, for example.

In particular, in this embodiment, an inflection point 116 (i.e., a straight portion having a length dimension of approximately 0) where the curvature of the outer peripheral surface 114 changes is provided in the vertical middle portion of the outer peripheral surface 114, and above the inflection point 116 on the outer peripheral surface 114, the center of curvature is located below the outer peripheral surface 114, and below the inflection point 116 on the outer peripheral surface 114, the center of curvature is located above the outer peripheral surface 114. In this embodiment, the inner diameter dimension of the outer peripheral surface 114 at the position where the inflection point 116 is formed is approximately equal to the outer diameter dimension of the fitting protrusion 108. Furthermore, as described below, when the elastic body 16 is assembled to the housing 12, the inner surface of the inner flange portion 48 of the housing body 24 is in contact with the outer surface of the fitting protrusion 108, so the inner diameter of the outer surface 114 at the position where the inflection point 116 is formed is approximately equal to the inner diameter of the inner flange portion 48, i.e., the inner diameter of the opening 14 and the inner diameter of the upper end surface 70 of the inner wall portion 66.

In addition, by forming the circular recess 110 in the center of the lower surface 106 of the elastic body 16, an annular flat surface 118 is formed as an annular surface located below the upper bottom surface 112 on the outer periphery side of the circular recess 110 on the lower surface (inner surface) 106 of the elastic body 16. In other words, the circular recess 110 is formed on the inner periphery side of the annular flat surface 118. The upper bottom surface 112 of the circular recess 110 can also be regarded as the lower surface (inner surface) of the elastic body 16, that is, it is also possible to grasp that the annular flat surface 118 protrudes from the outer periphery of the inner surface (upper bottom surface 112) of the elastic body 16 toward the inner side (downward). In either case, in this embodiment, the lower surface 106 of the elastic body 16 is configured to include the annular flat surface 118, the upper bottom surface 112, and the outer periphery surface 114 connecting them.

11(a) and (b), the state where the base member 26 is placed below the elastic body 16 (in other words, the state before the elastic body 16 is compressed) is shown by a two-dot chain line, and the radial width dimension of the annular flat surface 118 is made larger than the radial width dimension of the peripheral wall portion 60 of the base member 26. That is, as shown in FIG. 11(b), when the elastic body 16 is placed above the base member 26, the upper end surface 72 of the peripheral wall portion 60 of the base member 26 faces (abuts) the outer peripheral portion 120 of the annular flat surface 118 over the entire surface or a part of it, and the upper end surface 70 of the inner peripheral wall portion 66 of the base member 26 faces (is opposed to) the inner peripheral portion 122 of the annular flat surface 118 at a distance from each other in the vertical direction.

In this embodiment, the outer peripheral portion 120 of the annular flat surface 118 facing the upper end surface 72 of the peripheral wall portion 60 is a region extending from the radial middle portion of the annular flat surface 118 to the outer peripheral end, and the inner peripheral portion 122 of the annular flat surface 118 is a region extending from the radial middle portion of the annular flat surface 118 to the inner peripheral end. Here, in this embodiment, the connection portion between the outer peripheral surface 114 of the circular recess 110 and the annular flat surface 118 is curved in a chamfered shape, but such a chamfered curved surface does not have to be formed. In addition, the annular flat surface 118 is not necessarily formed only of a flat surface extending in the horizontal direction, and may include a chamfered curved surface, a C-chamfered inclined surface, unevenness, etc. in the inner peripheral portion 122 of the annular flat surface 118 connected to the outer peripheral surface 114 of the circular recess 110. However, the annular surface in the present invention does not necessarily have to include a flat surface that extends horizontally, but may be composed of an inclined surface that is inclined relative to the horizontal direction over the entire surface, a curved surface that is curved over the entire surface, a surface with continuous projections and recesses, etc.

In other words, in this embodiment, the inner diameter dimension of the annular flat surface 118 is approximately equal to the inner diameter dimension φα at the upper end surface 70 of the inner circumferential wall portion 66 and the inner diameter dimension φβ at the opening 14 of the housing 12.

In addition, in this embodiment, the inner peripheral edge portion of the upper end face 72 of the peripheral wall portion 60 is located approximately in the radial center of the annular flat surface 118 or slightly toward the inner peripheral side. In other words, the radial width dimension W1 (see FIG. 11(b)) of the outer peripheral portion 120 of the annular flat surface 118 facing the upper end face 72 of the peripheral wall portion 60 is approximately equal (W1 ≒ W2) to or slightly larger (W2 < W1) than the radial width dimension W2 (see FIG. 11(b)) of the inner peripheral portion 122 of the annular flat surface 118 facing the upper end face 70 of the inner peripheral wall portion 66. Furthermore, in this embodiment, the vertical dimension L (see FIG. 11B) of the inner peripheral surface (step portion) 68 of the peripheral wall portion 60 that overlaps with the inner peripheral portion 122 of the annular flat surface 118 when the elastic body 16 is compressed (described later) is larger than the radial width dimension W2 of the inner peripheral portion 122 of the annular flat surface 118 (W2 < L). It is preferable that the vertical dimension L of the inner peripheral surface 68 is equal to or larger than the radial width dimension W2 of the inner peripheral portion 122 (W2 ≦ L).

Furthermore, it is preferable that the radial width dimension W3 (see FIG. 11(b)) of the upper end surface 70 of the inner peripheral wall portion 66 is approximately the same as the depth dimension D5 (see FIG. 11(b)) of the circular recess 110, and it is preferable that the arc-shaped curved length dimension of the outer peripheral surface 114 of the circular recess 110 is set to be equal to or greater than the radial width dimension W3 of the upper end surface 70 of the inner peripheral wall portion 66. It is also preferable that the vertical dimension L of the inner peripheral surface 68 is set to be equal to or greater than the depth dimension D5 of the circular recess 110 (D5 ≦ L).

The subcutaneously implantable port 10 of this embodiment is constructed by assembling the elastic body 16 having the above-described structure to the housing 12. The method of assembling the elastic body 16 to the housing 12 to manufacture the subcutaneously implantable port 10 is described below.

First, the elastic body 16 is placed on the base member 26 to which the port member 90 is attached, and the housing main body 24 is overlapped from above. That is, the lower surface 106 (annular flat surface 118) of the elastic body 16 is overlapped with the upper end surface 72 of the peripheral wall portion 60 of the base member 26, and the upper surface 104 (flat surface 109) of the elastic body 16 is overlapped with the inner peripheral flange portion 48. In addition, this overlapping causes the outer peripheral surface of the elastic body 16 to overlap with the inner peripheral surface 34 (inclined surface 34a) of the tapered tube portion 36 of the housing 12 (housing main body 24). The outer peripheral surface of the elastic body 16 is subjected to pressure from the inclined surface 34a of the tapered tube portion 36, and the circular recess 110 of the elastic body 16 bulges downward. However, before the elastic body 16 is compressed, the outer peripheral surface of the elastic body 16 and the inclined surface 34a may be separated, and the outer peripheral surface of the elastic body 16 and the inclined surface 34a may overlap and come into close contact with each other due to the expansion deformation caused by the compression of the elastic body 16.

Then, from this state, the housing body 24 and the base member 26 are fixed to each other by ultrasonic welding, and the housing body 24 and the base member 26 are assembled to manufacture the subcutaneously implantable port 10 of this embodiment. As a result, the elastic body 16 is fixed in a compressed state between the housing body 24 and the base member 26 in the vertical direction, and the upper opening of the peripheral wall 28 (the opening 14 of the housing 12) is closed with the elastic body 16. Therefore, by closing the upper opening of the peripheral wall 28 with the elastic body 16 and covering the lower opening with the base member 26, i.e., by covering the upper opening in the central recess 64 of the base member 26 with the elastic body 16, the lumen 18 of the subcutaneously implantable port 10 is formed between the elastic body 16 and the base member 26.

In this way, by pressing the inner flange portion 48 of the housing 12 (housing main body 24) against the flat surface 109 on the upper surface 104 of the elastic body 16, the locking claws 50 provided at the protruding tip of the inner flange portion 48 bite into and lock into the inner portion of the flat surface 109, and the fitting protrusion 108 of the elastic body 16 fits into the inner side of the inner flange portion 48. In particular, by compressing the outer peripheral portion of the elastic body 16 in the vertical direction, the upper end surface of the fitting protrusion 108 provided in the central portion of the elastic body 16 protrudes above the upper end surface of the inner flange portion 48.

Since the vertical separation distance D2 between the peripheral wall portion 60 and the inner flange portion 48 in the housing 12 is smaller than the vertical dimension D1 of the elastic body 16 in a single state, the outer peripheral portion of the elastic body 16 is compressed until the vertical dimension becomes D2 by sandwiching the elastic body 16 between the housing main body 24 and the base member 26 in the vertical direction and assembling them. Specifically, the outer peripheral portion 120 of the annular flat surface 118 of the elastic body 16 is compressed in the vertical direction by the peripheral wall portion 60 of the base member 26 and the inner flange portion 48 of the housing main body 24. In this embodiment, the outer diameter of the elastic body 16 before compression is slightly smaller than the outer diameter of the peripheral wall portion 60, and the upper end surface 72 of the peripheral wall portion 60 is partially in contact with the outer circumferential portion 120 of the annular flat surface 118. However, when the elastic body 16 is compressed in the vertical direction, it is expanded and deformed in the horizontal direction, and the upper end surface 72 of the peripheral wall portion 60 is in contact with the entire outer circumferential portion 120 of the annular flat surface 118.

That is, in this embodiment, in the product state in which the elastic body 16 is assembled to the housing 12, the outer peripheral portion 120 of the annular flat surface 118 is held in a compressed state in the thickness direction of the elastic body 16, and the compression holding portion facing the outer peripheral portion 120 of the annular flat surface 118 is constituted by the peripheral wall portion 60. Also, the annular flat compression surface constituting the compression holding portion (peripheral wall portion 60) in the base member 26 is constituted by the upper end surface 72 of the peripheral wall portion 60. The inner peripheral surface of the tapered tube portion 36 that is superimposed on the elastic body 16 from the outer peripheral side is made into an inclined surface 34a that gradually inclines toward the inner peripheral side toward the upper side. The inclined surface 34a compresses the outer peripheral surface of the elastic body 16 so as to release the elastic body 16 compressed by the compression holding portion (peripheral wall portion 60) to the inside.

When the outer peripheral portion of the elastic body 16 is compressed in the vertical direction, in other words, the peripheral wall portion 60 (compression holding portion) is pressed from below against the outer peripheral portion 120 of the annular flat surface 118, the inner peripheral portion 122 of the annular flat surface 118 is turned toward the outer periphery around the inner peripheral edge portion of the upper end surface 72 of the peripheral wall portion 60, i.e., is bent and deformed in the direction of arrow A1 in Figure 11 (b), so that at least a part of the inner peripheral portion 122 is horizontally superimposed on the inner peripheral surface (step portion) 68 of the peripheral wall portion 60. In addition, as the inner peripheral portion 122 of the annular flat surface 118 deforms toward the outer peripheral side, the outer peripheral surface 114 of the circular recess 110 continuing from the inner peripheral portion 122 turns toward the inner side (downward), i.e., is deformed in the direction of arrow A2 in FIG. 11(b), so that at least a portion of the outer peripheral surface 114 abuts against the upper end surface 70 of the inner peripheral wall portion 66 in the vertical direction without a large abutment force (compression force). In other words, in this embodiment, when the elastic body 16 is assembled to the housing 12, the abutment surface against which the outer peripheral surface 114 of the circular recess 110 that has turned toward the inner side (downward) abuts is formed by the upper end surface 70 of the inner peripheral wall portion 66.

In other words, the outer peripheral portion of the elastic body 16 is compressed in the vertical direction, and the compression holding portion (circumferential wall portion 60) is pressed from below against the outer peripheral portion 120 of the annular flat surface 118 of the elastic body 16, so that the circular recess 110 of the elastic body 16 bulges downward. That is, the outer peripheral surface 114, which is the outer peripheral portion of the circular recess 110, is pulled in the direction of the arrow A2. The circular recess 110 bulges downward, and the depth dimension of the circular recess 110 gradually decreases, and eventually the circular recess 110 is bulged downward below the lower surface 106 of the elastic body 16 (the outer peripheral portion 120 of the annular flat surface 118). In addition, the circular recess 110 is formed on the inner peripheral side of the annular flat surface 118, which compresses and holds the outer peripheral portion of the elastic body 16, and the protruding deformation height of the inner surface side of the elastic body 16 (on the inner peripheral side of the compression holding portion (circumferential wall portion 60)) caused by the outer peripheral portion of the elastic body 16 being compressed and held is suppressed. This reduces the pressure on the upper end surface 70 of the inner wall portion 66, which is the contact surface, and also ensures the volume of the storage area (inner cavity 18) formed below the position of the upper end surface 70.

Therefore, in this embodiment, after the elastic body 16 is assembled to the housing 12, the bulging surface 124 (see FIG. 3) that bulges downward on the inner circumferential side of the compression retaining portion (circumferential wall portion 60) is configured to include the upper bottom surface 112 and the outer circumferential surface 114 of the circular recess 110 before the elastic body 16 is assembled to the housing 12. In particular, in this embodiment, the outer circumferential portion of the bulging surface 124, i.e., the portion that corresponds to the outer circumferential surface 114 of the circular recess 110 before compression, is overlapped with the upper end surface 70 of the inner circumferential wall portion 66 without any gaps and lightly abuts against it, i.e., abuts against it without a large abutment force (compression force). That is, since the bulging surface 124 does not abut against the upper end surface 70 of the inner wall portion 66 with a large abutment force (the upper end surface 70 of the inner wall portion 66 is not strongly pressed against the bulging surface 124), the bulging surface 124 is prevented from bulging further downward on the inner circumferential side of the inner wall portion 66. Therefore, in this embodiment, the bulging surface 124 is made into a substantially circular flat surface, and its outer circumferential portion abuts against the abutment surface (the upper end surface 70 of the inner wall portion 66). In this embodiment, the upper surface of the inner cavity 18 is formed by the flat bulging surface 124. The outer circumferential portion of the bulging surface 124 may be formed by the outer circumferential surface 114 or the upper bottom surface 112 of the circular recess 110 as described above, or may be formed by including the inner circumferential portion 122 of the annular flat surface 118 in addition to the outer circumferential surface 114 and the upper bottom surface 112.

In addition, in this embodiment, the outer peripheral portion of the bulging surface 124 and the abutment surface (upper end surface 70 of the inner peripheral wall portion 66) are in contact with each other with approximately zero touch, while on the outer peripheral side of the abutment surface 70, the outer peripheral portion of the elastic body 16 is compressed in the vertical direction by the compression retaining portion (circumferential wall portion 60 and inner peripheral flange portion 48). That is, in this embodiment, the outer peripheral portion of the elastic body 16 is compressed in the vertical direction with a certain degree of compressive force by the compression retaining portion, and on the inner peripheral side of the compression retaining portion, the outer peripheral portion of the bulging surface 124 and the abutment surface 70 are in contact (abutment) with a compressive force (abutment force) smaller than that of the compression retaining portion.

As shown in Fig. 12, when a prototype of the subcutaneously implantable port 10 according to the present invention was actually produced and its internal cross section was photographed by computer tomography, it was confirmed that the circular recess (110) formed in the elastic body 16 before assembly to the housing 12 had disappeared, forming a bulging surface 124, and that the bulging surface 124 had become a flat surface with almost no irregularities, and its outer periphery abutted against the abutment surface (upper end surface 70 of the inner peripheral wall portion 66). The inventors also confirmed through actual experiments that assembling the elastic body 16 to the housing 12 causes the annular flat surface 118 to deform and abut against the inner peripheral surface (step portion) 68 of the peripheral wall portion 60.

The subcutaneously embedded port 10 constructed as described above is embedded subcutaneously in the chest, abdomen, thigh, etc. of a patient, and an external conduit such as a catheter 96 extending from the subcutaneously embedded port 10 is inserted into a target internal lumen such as a blood vessel. When injecting a drug solution in such an attached state, as shown by the two-dot chain line in FIG. 13, a coreless needle 126 as a needle is inserted into the elastic body 16 of the subcutaneously embedded port 10 through the patient's skin and reaches the lumen 18. Then, by operating a syringe (not shown) attached to the coreless needle 126, the drug solution contained in the syringe is injected through the lumen 18 from the drug solution outflow channel 22 through the catheter 96 into the target blood vessel, etc.

After the drug solution is injected, the coreless needle 126 is removed, and the puncture hole in the elastic body 16 is automatically closed by the elastic restoration action of the elastic body 16.

In the subcutaneously implantable port 10 of this embodiment, which has the above-described structure, the outer peripheral portion of the elastic body 16 is sandwiched between the housing main body 24 and the base member 26 in the thickness direction and compressed, so that the inner peripheral portion 122 of the annular flat surface 118 of the elastic body 16 turns toward the outer peripheral side (the direction of the arrow A1 in FIG. 11(b)) and is horizontally overlapped with the inner peripheral surface of the compression holding portion (peripheral wall portion 60), and the outer peripheral surface 114 of the circular recess 110 of the elastic body 16 turns toward the inner peripheral side (the direction of the arrow A2 in FIG. 11(b)) and is axially overlapped with the abutment surface (the upper end surface 70 of the inner peripheral wall portion 66). This prevents the occurrence of a gap between the elastic body 16 and the housing 12, or makes it smaller if a gap occurs.

In addition, by sandwiching and compressing the outer peripheral portion of the elastic body 16 between the housing main body 24 and the base member 26, the circular recess 110 of the elastic body 16 bulges downward to form a bulging surface 124, and the outer peripheral portion of the bulging surface 124 abuts against the abutment surface 70 with approximately zero touch. That is, when the abutment surface 70 is strongly pressed against the outer peripheral portion of the bulging surface 124, the bulging surface 124 of the elastic body 16 bulges downward and deforms, which may cause a gap as shown in FIG. 14 between the housing 12 (base member 26), but in the subcutaneous implantable port 10 of this embodiment, such a risk is avoided or, even if a gap is formed, it can be made small. As a result, when a medicinal liquid is stored in the lumen 18, the medicinal liquid is prevented from stagnating in the gap, or the stagnation is suppressed to a small extent.

Furthermore, the outer peripheral portion of the elastic body 16 is sandwiched between the housing main body 24 and the base member 26 in the vertical direction with a certain degree of compressive force, so that the elastic body 16 can be firmly fixed to the housing 12. This makes it possible to more reliably prevent the elastic body 16 from falling out of the housing 12, even when, for example, a highly viscous and high-flow rate drug solution is used and the pressure in the lumen 18 increases. Incidentally, when the elastic body is firmly attached to the housing in this way, the elastic body is generally strongly compressed in the vertical direction, but this tends to cause, for example, the lower surface of the elastic body to bulge downward, resulting in a gap between the elastic body and the housing. In addition, the strongly compressed portion of the elastic body is greatly recessed, making it easy for a gap to form between the elastic body and the housing. In contrast, in the subcutaneously implantable port 10 of this embodiment, the outer peripheral portion of the elastic body 16 is compressed and firmly attached to the housing 12, while the lower surface (bulge surface 124) of the elastic body 16 on the inner side abuts against the abutment surface 70 of the base member 26 with approximately zero touch, so that it is possible to achieve both a strong attachment of the elastic body 16 to the housing 12 and prevention of the occurrence of gaps between the elastic body 16 and the housing 12.

In addition, in this embodiment, the housing 12 has a divided structure including a housing main body 24 and a base member 26, and the elastic body 16 is supported by being sandwiched between the housing main body 24 and the base member 26 in the thickness direction, which makes it easy to assemble the elastic body 16 to the housing 12.

Furthermore, in this embodiment, the locking claw 50 provided on the protruding tip (inner peripheral edge) of the inner peripheral flange portion 48 in the housing 12 is locked to the outer surface (upper surface 104) of the elastic body 16. Therefore, even if, for example, a highly viscous drug solution is stored and the pressure in the inner cavity 18 increases, the elastic body 16 can be prevented from falling out of the housing 12 to the outer surface side (upward).

Furthermore, in this embodiment, the inner diameter dimension φα of the abutment surface of the base member 26 (the inner diameter dimension at the upper end surface 72 of the inner wall portion 66) is approximately equal to the inner diameter dimension φβ of the opening 14 of the housing 12 (the inner diameter dimension of the inner flange portion 48). In other words, since the inner diameter dimension φβ of the opening 14 is approximately equal to the inner diameter dimension of the upper part of the inner cavity 18, when the coreless needle 126 is inserted into the elastic body 16 through the opening 14, the tip of the coreless needle 126 is stably guided into the inner cavity 18, and it is possible to prevent, for example, the coreless needle 126 from piercing the base member 26 out of the inner cavity 18.

In addition, in this embodiment, the inner peripheral surface of the tapered tube portion 36, which is overlapped from the outer peripheral side with the elastic body 16 in the housing 12, is an inclined surface 34a that gradually inclines inward as it goes upward. The inclined surface 34a acts to favorably release the elastic body 16 compressed by the compression retaining portion (peripheral wall portion 60) to the inside, making it easier to expand the circular recess 110 downward.

Although the embodiments of the present invention have been described above, the present invention should not be interpreted as being limited to the specific descriptions in the embodiments, and can be implemented in various forms with various changes, modifications, improvements, etc. based on the knowledge of those skilled in the art.

For example, in the above embodiment, the port member 90 and the base member 26 are formed as separate bodies, but they may be formed as one body, i.e., the port portion may be formed integrally with the base member and protrude outward in the horizontal direction. Also, in the above embodiment, the housing 12 is configured to include the housing main body 24 and the base member 26 that can be separated in the vertical direction, but the housing may have a structure that can be separated in the horizontal direction, may be formed of multiple members, or may be formed as one body. Furthermore, each of the members such as the housing main body and the base member does not have to be a single member, and each may be composed of multiple members. Furthermore, the housing main body and the base member do not have to be fixed by direct joining or engagement, and may be fixed by assembling separate members, etc.

In addition, in the above embodiment, the recess formed on the lower surface 106 of the elastic body 16 is a circular recess 110, but the shape of the recess is not limited to a circle, and may be a polygon, an ellipse, a semicircle, or a combination of these. In addition, the recess may be annular, and may be in the shape of a circular ring or a polygonal ring.

Furthermore, in the above embodiment, the outer peripheral surface 114 of the circular recess 110 in the elastic body 16 is curved over substantially the entire length in the cross section shown in FIG. 11, but it may be linear, for example, partially or over substantially the entire length. Even if the outer peripheral surface of the recess is linear, it may be parallel to the vertical direction or inclined relative to the vertical direction.

In addition, in the above embodiment, the upper surface 104 and lower surface 106 of the elastic body 16, the upper end surface 72 of the peripheral wall portion 60, and the upper end surface 70 of the inner peripheral wall portion 66 are all flat surfaces that extend in the horizontal direction, but they may be flat surfaces that extend at an angle relative to the horizontal direction. Furthermore, in the above embodiment, the inner peripheral surface 68 of the peripheral wall portion 60 extends parallel to the vertical direction, but it may be inclined relative to the vertical direction.

Furthermore, in the above embodiment, the locking claw 50 that is locked to the upper surface 104 of the elastic body 16 is formed to protrude downward from the protruding tip (inner peripheral edge) of the inner flange portion 48 of the housing main body 24, but the locking claw may be provided, for example, on the inner peripheral surface of the tapered tube portion 36 instead of the protruding tip of the inner flange portion, or may be provided on both the protruding tip of the inner flange portion and the inner peripheral surface of the tapered tube portion. However, such a locking claw is not essential to the present invention. Also, a locking recess corresponding to the locking claw may be provided in the elastic body 16. Furthermore, in the contact surface 70 of the base member 26, where the lower surface 106 of the annular flat surface 118 of the elastic body 16 is overlapped, the compression surface (upper end surface 72 of the peripheral wall portion 60), the stepped portion (inner peripheral surface 68 of the peripheral wall portion 60), etc., unevenness such as locking claws may be provided, or each surface may be inclined in the horizontal or vertical direction, taking into consideration the restraining force on the elastic body 16, etc.

In addition, in the above embodiment, before the elastic body 16 is compressed, the outer peripheral portion 120 of the annular flat surface 118 facing the upper end surface 72 of the peripheral wall portion 60 reaches from the radial middle portion of the annular flat surface 118 to the outer peripheral end, and the inner peripheral portion 122 of the annular flat surface 118 facing the upper end surface 70 of the inner peripheral wall portion 66 reaches from the radial middle portion of the annular flat surface 118 to the inner peripheral end, but this is not limited to such an embodiment. In other words, the outer peripheral portion or inner peripheral portion of the annular flat surface may be the radial middle portion of the annular flat surface without reaching the outer peripheral end or inner peripheral end.

Furthermore, in the above embodiment, the outer peripheral portion of the elastic body 16 is compressed in the vertical direction to form a substantially circular flat bulging surface 124, and the outer peripheral portion of the bulging surface 124 abuts against the abutment surface (the upper end surface 70 of the inner peripheral wall portion 66) with substantially zero touch, but this is not limited to such an embodiment. That is, the inner peripheral wall portion may apply a compressive force to the elastic body. When the peripheral wall portion applies the necessary compressive force to the elastic body to firmly fix the elastic body, the inner peripheral wall portion located below the peripheral wall portion applies a weaker compressive force to the elastic body than the peripheral wall portion, and the deformation of the elastic body due to compression is small. Therefore, the gap generated between the elastic body and the housing is smaller than that of the conventional one. In addition, the bulging surface does not need to be a completely flat surface, and may have some unevenness. In addition, the outer peripheral portion of the bulging surface may abut against the abutment surface with a certain degree of compressive force, that is, the outer peripheral portion of the bulging surface may be compressed to a certain degree by the abutment surface. As described above, there is a risk of gaps being formed in the inner cavity due to unevenness or compression of the expanding surface, but as long as the retention of the drug solution is almost completely eliminated or only slightly eliminated, gaps may be formed in the inner cavity, for example, between the housing and the elastic body. In other words, by adopting the structure according to the present invention, even if the gap between the housing and the elastic body is not completely eliminated, the size of the gap is almost certainly reduced, so that the effect of suppressing retention of the drug solution can be fully achieved.

The specific structure and shape of the housing are not limited to those of the above embodiment. For example, while the housing is composed of two members in the above embodiment, it may be composed of one or three or more members. Specifically, as shown in FIG. 14, it is also possible to configure a subcutaneously implantable port 132 by assembling a ring member 130, which is a separate member, to the base member 26 that constitutes the housing 12. For ease of understanding, the same reference numerals as those in the above embodiment are used in FIG. 14 for members and parts that have the same structure as the above embodiment.

In particular, the ring member 130 shown in FIG. 14 is assembled inside the housing 12 and is not exposed on the surface of the housing 12. Such a ring member 130 can be made of, for example, an X-ray impermeable material to enable confirmation of the position, etc., of the subcutaneously implantable port 132 when it is embedded using an X-ray, or can be made to have an identification mark visible from the outside through the housing body 24 made of a visible light transmitting material by, for example, applying a marking such as laser marking or engraving to the outer circumferential surface, or can be made of, for example, a material such as a metal having a higher strength than the base member 26 to be used as a reinforcing member for the base member 26.

The ring member 130 of this embodiment replaces a part of the base member 26 of the previous embodiment, and in this embodiment, the housing 12 is made up of the housing main body 24, the base member 26, and the ring member 130. The ring member 130 is located at the outer circumferential corner of the upper end of the peripheral wall portion 60 of the base member 26, and is assembled in an externally fitted state to the peripheral wall portion 60. As a result, the outer circumferential portion of the upper end surface (compression surface) 72 of the base member 26 is made up of the upper end surface of the ring member 130.

That is, in this embodiment, the surface that overlaps with the outer peripheral portion 120 of the annular flat surface 118 of the elastic body 16 is formed by the base member 26 and the ring member 130 in the housing 12 in cooperation with each other. With the structure shown in Fig. 14, the same effects as those of the above embodiment can be effectively achieved. Note that, for example, in the peripheral wall portion 60 of the base member 26, the entire portion located on the outer peripheral side of the inner peripheral wall portion 66 can be formed of a ring member, and the upper end surface (compression surface) 72 and the entire stepped portion 68 can be formed of a ring member that is a separate part from the base member 26.
Furthermore, the present invention originally includes each of the inventions described in (i) to (vi) below, and the configurations and effects thereof will be described below.
The present invention relates to
(i) A subcutaneously implantable port comprising an elastic body and a housing assembled to compress the elastic body in a thickness direction, the opening of the housing being blocked by the elastic body to form an inner cavity for storing a medicinal solution, the inner surface of the elastic body before assembly into the housing having an annular surface protruding toward the inner surface and a recessed portion located on the inner periphery of the annular surface, while the housing has, at a portion facing the annular surface of the elastic body, a compression retaining portion for compressing an outer periphery of the annular surface in the thickness direction when assembled, and a contact surface formed on the inner periphery of the compression retaining portion, having a height lower than the compression retaining portion, and contacting the inner surface of the elastic body when assembled into the housing, and compression at the compression retaining portion causes the outer periphery of the recessed portion of the elastic body to change direction toward the inner surface, with at least a portion of the recessed portion overlapping with the contact surface;
(ii) A subcutaneously implantable port in which an opening of a housing is blocked with an elastic body to form an internal cavity for storing a medicinal solution, the inner surface of the elastic body having an annular surface at an outer circumferential portion and a recess on the inner circumferential side of the annular surface, while the housing has a compression retaining portion that retains the outer circumferential portion of the annular surface of the elastic body in a compressed state in the thickness direction, the recess of the elastic body bulging downward by compression at the compression retaining portion to form a bulging surface on the inner circumferential side of the compression retaining portion, and the bulging surface is superimposed without a gap against an abutment surface provided in the housing on the inner circumferential side of the compression retaining portion and below the compression retaining portion.
(iii) The subcutaneous implantable port according to (i) or (ii), wherein the housing is provided with a locking claw that is locked to an outer circumferential portion of the outer surface of the elastic body.
(iv) the subcutaneously implantable port according to any one of (i) to (iii), wherein the housing includes a base member and a housing main body that are assembled together in a thickness direction of the elastic body, and the base member is provided with an annular flat compression surface that constitutes the compression retaining portion, and a contact surface that is located below the inner circumferential side of the compression surface with a step portion therebetween and that comes into contact with the inner surface of the elastic body when the elastic body is assembled to the housing;
(v) the subcutaneous implantable port according to any one of (i) to (iv), wherein the housing has an inner diameter dimension of a contact surface that comes into contact with an inner surface of the elastic body when the elastic body is assembled to the housing, the inner diameter dimension of the contact surface being equal to or larger than the inner diameter dimension of the opening.
(vi) A method for manufacturing a subcutaneously implantable port in which an opening of a housing is blocked with an elastic body to form a cavity for storing a medical solution, the method using an elastic body having an annular surface on an outer circumferential portion on an inner surface located on the cavity side and having a recess on the inner circumferential side of the annular surface, and when assembling the elastic body to the housing, the outer circumferential portion of the annular surface of the elastic body is compressed in the thickness direction to hold the elastic body in a compression retaining portion of the housing, and the recess of the elastic body is expanded downward to bring the elastic body into contact with an annular abutment surface provided on the inner circumferential side of the compression retaining portion of the housing and below the compression retaining portion with a smaller abutment force than the compression retaining portion.
This includes inventions relating to.
In the invention described in (i) above, the outer peripheral portion of the inner surface of the elastic body is compressed in the thickness direction by the compression retaining portion of the housing, so that the outer peripheral portion of the inner surface of the elastic body is deformed upward. The deformation caused by the compression retaining portion is likely to occur in the inner peripheral portion of the annular surface, but is unlikely to occur in the recessed portion. The inner peripheral portion of the annular surface is likely to deform significantly because of the recessed portion on the inside, and is likely to deform toward the compression retaining portion following the outer peripheral portion of the annular surface. Therefore, the inner peripheral portion of the annular surface deforms to fill the gap caused by compression by the compression retaining portion, so that the gap between the compression retaining portion and the elastic body due to compression can be made smaller than in the past. Specifically, the inner peripheral portion of the annular surface deforms, and the recessed portion in the elastic body changes direction to overlap with the abutment surface of the housing, so that the occurrence of a gap in the thickness direction of the elastic body between the elastic body and the housing is avoided, or even if a gap occurs, its size is kept small. This can avoid or suppress the retention of the drug solution in the lumen.
In the invention described in (ii) above, the outer peripheral portion of the inner surface of the elastic body is compressed in the thickness direction by the compression retaining portion of the housing, so that the outer peripheral portion of the inner surface of the elastic body is deformed upward. The deformation caused by the compression retaining portion is likely to occur in the inner peripheral portion of the annular surface, but is unlikely to occur in the recessed portion. The inner peripheral portion of the annular surface is likely to deform significantly because of the recessed portion on the inside, and is likely to deform toward the compression retaining portion following the outer peripheral portion of the annular surface. Therefore, the inner peripheral portion of the annular surface deforms to fill the gap caused by compression by the compression retaining portion, so that the gap between the compression retaining portion and the elastic body due to compression can be made smaller than in the past. Specifically, the recessed portion of the elastic body expands and overlaps with the abutting surface of the housing, so that the bulging deformation caused by the compression of the elastic body can be skillfully used to reduce the height difference between the bottom surface of the recessed portion and the abutting surface, and the occurrence of a gap between the elastic body and the housing is avoided, or even if a gap occurs, its size is kept small. This can avoid or suppress the retention of the drug solution in the lumen.
In the invention described in (iii) above, the locking claws on the housing are engaged with the outer surface of the elastic body, so that the elastic body can be prevented from falling off to the outside from the housing even when, for example, a medicinal solution is filled and the pressure in the inner cavity increases.
In the invention described in (iv) above, the housing has a divided structure consisting of a base member and a housing main body, and the elastic body is sandwiched between the base member and the housing main body in the thickness direction and assembled, making it easy to assemble the elastic body to the housing.
In the invention described in (v) above, when the needle is inserted into the elastic body, the risk that the tip of the needle will not enter the inner cavity and will strike the housing can be reduced.
In the invention described in (vi) above, by assembling the elastic body to the housing while the outer peripheral portion of the elastic body is compressed by the compression retaining portion, the recess is expanded downward and the elastic body contacts the abutment surface of the housing with a relatively small abutment force on the inner side of the compression retaining portion, so that the elastic body can be assembled to the housing while avoiding or reducing gaps between the elastic body and the housing.

10, 132: Subcutaneously implantable port, 12: Housing, 14: Opening, 16: Elastic body, 18: Inner cavity, 24: Housing body, 26: Base member, 50: Engagement claw, 60: Circumferential wall portion (compression holding portion), 68: Inner surface of the circumferential wall portion (step-shaped portion), 70: Upper end surface of the inner wall portion (contact surface), 72: Upper end surface of the circumferential wall portion (compression surface), 104: Upper surface (outer surface of the elastic body), 106: Lower surface (inner surface of the elastic body), 110: Circular recess (recess), 114: Outer surface of the recess, 118: Annular flat surface (annular surface), 120: Outer portion of the annular flat surface, 122: Inner portion of the annular flat surface, 124: Bulging surface, 130: Ring member

Claims (7)

A subcutaneously implantable port comprising: an elastic body; and a housing assembled to compress the elastic body in a thickness direction, the housing having an opening that is closed by the elastic body to form a lumen for storing a medicinal solution,
The elastic body before being assembled to the housing has an inner surface formed with an annular surface protruding toward the inner surface and a recessed portion located on the inner circumferential side of the annular surface,
the housing has a compression retaining portion facing the annular surface of the elastic body for compressing an outer circumferential portion of the annular surface in a thickness direction during assembly,
A subcutaneously implantable port in which an inner peripheral portion of the annular surface of the elastic body is redirected toward the outer peripheral side by compression at the compression retaining portion, at least a portion of which overlaps with the inner peripheral surface of the compression retaining portion. 2. The subcutaneously implantable port according to claim 1, wherein an upper end surface of the compression holding portion is a flat surface. 3. The subcutaneous implantable port according to claim 1 or 2, wherein the housing is provided with a locking claw that is engaged with an outer peripheral portion of the outer surface of the elastic body, and the protruding tip of the locking claw is located more inward than the compression retaining portion. The housing is provided with an inner peripheral wall portion on an inner peripheral side of the compression retaining portion, the inner peripheral wall portion being lower in height than the compression retaining portion,
4. The subcutaneously implantable port according to claim 3, wherein the inner circumferential wall portion faces the engaging claw. 5. The subcutaneous implantable port according to claim 4, wherein the distance between the engaging claw and the inner wall portion of the housing in the thickness direction of the elastic body is greater than the distance between the portion outer circumferentially further away than the engaging claw and the compression retaining portion. The housing has a tapered cylindrical portion whose inner diameter gradually decreases toward the top, and the outer circumferential surface of the elastic body is superimposed on the inner circumferential surface of the tapered cylindrical portion,
6. The subcutaneous implantable port according to claim 1, wherein the taper angle of the inner peripheral surface of the tapered tubular portion is larger than the taper angle of the outer peripheral surface of the elastic body that is overlaid on the tapered tubular portion before assembly into the housing. 1. A method for manufacturing a subcutaneously implantable port comprising: an elastic body; and a housing that is assembled to compress the elastic body in a thickness direction, the housing having an opening that is closed with the elastic body to form a lumen for storing a medicinal solution, the method comprising the steps of:
Before being assembled, the inner surface of the elastic body is formed with an annular surface protruding toward the inner surface and a recess located on the inner circumferential side of the annular surface,
the housing has a compression retaining portion facing the annular surface of the elastic body for compressing an outer circumferential portion of the annular surface in a thickness direction during assembly,
The compression retention portion is formed by deforming an inner peripheral portion of the annular surface of the elastic body toward the compression retention portion when an outer peripheral portion of the annular surface of the elastic body is compressed.

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