Ports adapted for frequent access

Abstract

The port is adapted to be implanted into the body with its upper portion exposed to the environment. The port has a housing defining a chamber with an opening at its upper portion. An aperture with a lumen attached is formed at the lower portion of the chamber. For injection, an insert having an internal passage connecting the fluid inlet at the upper surface with a hole in the side wall is sealingly engaged with the chamber. The hole is sealingly aligned with the aperture. After injection, the insert is removed and a blank insert is fitted into the chamber. A tissue ingrowth medium surrounds the housing to form a sterility barrier where the outer wall of the housing contacts the body tissue surrounding the housing.

Description

Technical Field

[0001]

[0001] The present invention relates to a port adapted to be implanted in a patient, and more particularly, to a port adapted to be partially implanted in a patient and capable of being accessed frequently without using a needle.

Background Art

[0002]

[0002] A portal or port is typically implanted subcutaneously in a patient and used to send fluid stored within the port's container to a location within the patient, such as the patient's vasculature. The most significant drawback of current implantable port assemblies after the port has been implanted in a patient is that a clinician must puncture the patient's skin using a needle or cannula to access the port container. Such punctures of the patient are inconvenient for several procedures that may need to be performed, such as frequent access to the port. For example, in procedures such as dialysis, frequent access to the implanted port, multiple times a week, is required. Such frequent access can interfere with healing at the site where the needle is inserted into the patient and may even cause infection at that site.

[0003]

[0003] Another drawback of conventional implantable ports is that after the port has been implanted in a patient, its location must be identified. One conventional method is to palpate the area of ​​the patient where the port has been implanted in order to locate the port. Other methods include providing an indicia on or within the port to allow observation of the port under X-ray, i.e., radiographic imaging. After inserting a needle into the patient, one or more impressions can be given to the port septum, along with radiopaque marks, to accurately identify the septum of the port from which the needle needs to be inserted. Such precise identification of the septum of an implantable port is described in U.S. Patents 8,092,435, 8,535,281, and 9,950,150 (all of which have been assigned to the assignor of this application). The disclosures of '435, '281, and '150' are incorporated herein by reference.

[0004]

[0004] Therefore, there is a need for a port that can be easily located and accessed frequently without the need to repeatedly puncture the patient's skin at the port site, and that can maintain sterility even when adapted for frequent access. [Overview of the Initiative]

[0005]

[0005] The port of the present invention has a housing adapted to be substantially implanted in a patient. The interior of the housing defines a chamber. An opening at the top of the housing exposes the chamber to the environment. An aperture is formed at the bottom of the chamber and penetrates the wall of the housing. The aperture is sized so that a lumen or catheter can extend from the inside of the chamber to the outside of the housing. A guide structure is provided in the wall where the aperture is formed, allowing the base of the lumen, for example, a flange, to be fixed to the housing. An alternative embodiment has an outer lumen fixedly attached to the aperture, and an inner lumen, for example, a catheter, can extend along this fixed lumen. In either case, it is assumed that if no lumen is attached, it can be replaced with another lumen after use, and if the outer lumen is fixedly attached to the housing, the inner lumen can be replaced with another inner lumen after use.

[0006]

[0006] An insertion part or plug is fitted into the chamber of the housing in a detachable and sealed manner. The height of the insertion part should be such that when fully engaged in the chamber, the upper surface of the insertion part is substantially flush with the upper part of the housing surrounding it. When the port is used for injection, the insertion part has an internal passage extending between the injection fluid inlet on the upper surface and the hole in the side wall of the insertion part. The insertion part has a substantially longitudinal guide structure on its outer surface that complements the guide structure on the inner wall of the housing, so that the insertion part can be fitted into the housing in a sealed manner in a predetermined orientation. This ensures that the hole in the insertion part is reliably aligned with the opening at the proximal or base of the lumen attached to the aperture of the housing. For ease of consideration, an insertion part with an internal passage may be called an injection plug or injection insertion part.

[0007]

[0007] The port housing is adapted to be implanted in the patient's body to a depth that exposes at least the upper surface of the insertion portion. The implantation of the housing allows the lumen of the housing to be selectively positioned within the patient, for example, in a vein, artery, or other location or tissue of the patient's vascular system. When the fluid reservoir is connected to the fluid inlet on the upper surface of the infusion insertion portion, the fluid pathway established by the passage within the infusion insertion portion and the lumen extending from the housing into the patient transports the fluid drug from the fluid reservoir to the selected location within the patient.

[0008]

[0008] After injection, the injection insertion part with an internal passage can be removed from the housing and replaced with a blank insertion part without an internal passage. The blank insertion part seals the chamber in a sealed but removable manner. That is, it is a blank insertion part or insertion plug that seals the chamber of the housing. The injection insertion part can then be discarded. When injection is needed again, the blank insertion part is replaced with a clean injection insertion part. Similarly, the lumen connected to the housing can be replaced with a clean lumen. If the lumen is fixedly attached to the housing and acts as an outer lumen, the used, contaminated inner lumen or catheter fitted along the lumen is removed and a new inner lumen is slidably fitted along the outer lumen.

[0009]

[0009] In order to prevent infection at the site where the port housing comes into contact with the patient's body, at least one group of tissue ingrowth media is attached to the outer wall of the housing and surrounds the outer wall, forming a sterile barrier at the point where the outer wall of the housing comes into contact with the patient's body tissue surrounding the port housing.

[0010]

[0010] Accordingly, the present invention relates to a port, the port comprising: a housing having an interior defined by a bottom, a non-terminal wall, and a top, the top having an opening that opens into the interior of the housing; at least one aperture at a selected position penetrating the non-terminal wall; and an insertion portion having a top surface and cross-sectional dimensions, the cross-sectional dimensions allowing it to engage with the interior of the housing through the opening of the housing, and the top surface being substantially planar with the top of the housing after insertion into the housing, the housing being adapted to be implanted in a body with the top surface of the insertion portion exposed to the environment.

[0011]

[0011] The present invention further relates to a port adapted to be implanted in the body while remaining partially visible. The port comprises a housing having an interior defined by a bottom, an outer non-terminal wall, and a top, the top having an opening that opens into the interior of the housing; at least one lumen extending away from the housing from at least one aperture in the non-terminal wall; and an insertion portion having a top surface and cross-sectional dimensions, the cross-sectional dimensions of which allow it to engage with the interior of the housing through the opening of the housing, wherein the housing of the port is implantable in the body to a depth that remains outside the body or at skin level so that the top surface of the insertion portion is visually visible.

[0012]

[0012] The present invention further relates to a port that is visually visible and accessible from the environment after implantation. The port comprises a housing having an interior defined by a bottom, an outer non-terminal wall, and an upper part, the upper part having an opening that opens into the interior of the housing; and an insertion portion having at least one lumen extending from at least one aperture in the non-terminal wall, a tissue growth medium surrounding the outer surface of the non-terminal wall, a top surface, and cross-sectional dimensions that engage with the interior of the housing through the opening of the housing, wherein the housing of the port is implantable into the body to a depth that maintains the upper surface of the insertion portion accessible from the environment, and after implantation into the body, the tissue growth medium forms a sterile barrier between the non-terminal wall and the body tissue surrounding this wall. [Brief explanation of the drawing]

[0013]

[0013] The present invention will become clearer and will be best understood by referring to the following description of the present invention in conjunction with the attached drawings.

[0014] [Figure 1A]

[0014] This is a perspective view of one embodiment of the port of the present invention. [Figure 1B]

[0015] Figure 1A is a side view of the port embodiment. [Figure 1C]

[0016] Figure 1A is a cross-sectional view of an embodiment of the port. [Figure 2]

[0017] This is an exploded perspective view showing the components of the port of the present invention. [Figure 3A]

[0018] This is a perspective view showing the internal chamber of the port housing of the present invention. [Figure 3B]

[0018] This is a perspective view showing the internal chamber of the port housing of the present invention. [Figure 4A]

[0019] This is an exploded perspective view showing components of another embodiment of the port of the present invention. [Figure 4B]

[0020] Figure 3A is a perspective view of the assembled port of the embodiment shown. [Figure 4C]

[0021] Figure 4B is a cross-sectional view of the port shown. [Figure 5A]

[0022] Another embodiment of the port of the present invention, in which the insertion portion has multiple passages, is shown. [Figure 5B]

[0022] Another embodiment of the port of the present invention having an insertion portion with multiple passages is shown. [Figure 6A]

[0023] This is a perspective view of a modified port of the present invention, showing a blank insertion part having a hole used when removing the insertion part from the housing. [Figure 6B]

[0024] It is a cross-sectional view along line B-B of the port shown in FIG. 6A. [Figure 6C]

[0025] An exemplary tool engaged with the port of FIG. 6 for removing the insertion part from the housing is shown. [Figure 6D]

[0026] It is an enlarged view of a part of the locking mechanism shown in FIGS. 6B to 6C. [Figure 6E]

[0027] The reaction of the locking part of the housing when the insertion part is fitted into the housing is shown. [Figure 6F]

[0028] The operating relationship between the insertion part of FIG. 6E and the locking parts of the locking mechanism of the housing and the insertion part of FIG. 6A is shown. [Figure 7A]

[0029] A side view of the exemplary tool is shown. [Figure 7B]

[0029] A perspective view of the exemplary tool is shown. [Figure 8A]

[0030] Another embodiment of the insertion part of the present invention is shown. [Figure 8B]

[0030] Another embodiment of the insertion part of the present invention is shown.

Mode for Carrying Out the Invention

[0015]

[0031] Referring to FIGS. 1A to 1C, FIG. 2, and FIGS. 3A to 3B, the percutaneous portal or port 2 of the present invention is shown including a housing 4 having a main part or upright part 4a and a base part 4b. The upright part 4b is formed by a non-terminal wall 4w which is a circumferential wall in the illustrated exemplary embodiment. The wall 4w extends upward from the base part 4b of the housing 4 to an upper part 4t having a downward taper. For ease of discussion, the upper part 4t is regarded as the upper surface of the housing 4 and may simply be referred to as the upper part 4t.

[0016]

[0032] As best illustrated in Figures 2 and 3A to 3B, the top 4t of the housing 4 opens into the interior 4i of the housing 4. Viewed in another way, the interior of the housing 4 is a chamber 4i defined by the inner circumferential wall or inner wall 4iw and bottom 4d of the housing 4, with the top open to the environment. An unterminated shoulder or step 4s is formed along the inner wall 4iw defining the chamber 4i at a short distance from the top 4t. The housing 4 can be formed from multiple inert plastic or metal materials, as is well known in port manufacturing.

[0017]

[0033] As best illustrated in Figure 3B, the housing 4 further has an aperture 4p that penetrates the base 4b at the lower part of the wall 4w. A tube, tubing, or lumen 6 slides and fits snugly through the aperture 4p, and its distal end 6d can be selectively positioned in the patient's body. Thus, after the housing 4 is percutaneously implanted in the patient, the output of the lumen can be guided, as is well known, to the veins and arteries of the patient's selected tissue or vascular system. The lumen 6 may be any tube, tubing, or catheter known to be used for fluid injection or extraction. In an exemplary embodiment, the proximal end 6p of the lumen 6 joins a key flange 6f having an opening 6o that forms the base or proximal opening of the lumen 6. As shown in Figures 3A to 3B, an internal structure 4f is formed in the inner wall 4iw containing the aperture 4p, which is sized to snugly accommodate the flange 6f of the lumen 6. In the embodiments shown in Figures 3A and 3B, assuming that the lumen 6 is not fixedly attached to the housing 4, the lumen used can be easily replaced with a new one. This will be explained further below.

[0018]

[0034] Port 2 also includes an insertion portion 8, which can be in the form of a plug adapted to engage tightly and in a sealed manner inside the housing 4 or chamber 4i. The insertion portion 8 may be manufactured from a variety of plastic or metal materials known to be used in the manufacture of ports. Hereafter, the insertion portion 8 may be referred to as the insertion portion, plug, or plug insertion portion.

[0019]

[0035] As best illustrated in Figures 1A to 1C and 2, the insertion portion 8 has a body 8a. In the illustrated exemplary embodiments, the body 8a is in the form of a cylindrical body structure or simply a cylinder, having cross-sectional dimensions and length that allow it to engage or fit tightly and slidably with the inside of the housing 4 or chamber 4i. A guide slot 8g is formed along the outer surface of the insertion portion 8, and assuming that the lumen 6 slides and is fully fitted into the aperture 4p of the housing 4, the insertion portion 8 can be guided along the guide slot 8g by the flange 6f when inserting it into the chamber 4i.

[0020]

[0036] In addition to acting as a guide for the insertion portion 8 into the housing 4, the flange 6f, in cooperation with the slot 8g, prevents relative rotation between the insertion portion 8 and the housing 4. The insertion portion 8 has an upper lip or flange 8f, from which a cylindrical body 8a hangs integrally. When the lip 8f contacts the step 4s of the housing 4, the insertion portion 8 is fully inserted into the housing 4. When fully engaged with the chamber 4i in this way, the upper surface 8t of the insertion portion 8 is exposed to the environment.

[0021]

[0037] When a fluid drug is injected into a patient or body fluid is collected from a patient during an infusion or other procedure, a through passage 8p is formed in the insertion section 8. The passage 8p extends from the upper surface 8t of the insertion section 8 to the opening 8o of the guide slot 8g. As shown in Figure 1C, the opening 8g is formed in the slot 8g such that it is aligned in a sealed manner with the proximal opening 6o of the lumen 6 when the plug 8 is fully engaged with the housing 4. It will be noted that the opening 80 does not need to be formed in the slot 8, as long as it is positioned to align with the entrance of the lumen or catheter from which the fluid is discharged. For example, if the lumen is fixedly attached to the housing, or if the base flange of the lumen is fitted into the aperture and is coplanar with the inner wall of the housing, a supplementary guide mechanism for the housing and insertion section can be provided at a location away from where the entrance of the lumen contacts the exit of the passage.

[0022]

[0038] To facilitate fluid injection, an injection port or fluid inlet 8i is provided or formed on the upper surface 8t of the insertion section 8. As is well known, the inlet 8i is adapted to be coupled to the outlet of the fluid storage section, so that the drug stored in the fluid storage section can be transported through the passage 8p and the internal passage 6i of the lumen 6, and output to a selectively positioned location within the patient at the distal end of the lumen.

[0023]

[0039] At least one group of tissue growth media 10 is attached to and surrounds the outer circumferential surface of the upright wall 4w of the housing 4. The tissue growth media may be any available biomaterial and may include polymers, tantalum, titanium, ceramics, and other materials that integrate well with the skin to prevent bacterial invasion. An exemplary tissue growth medium that may be used to surround the housing 4 of the port 2 may be a porous titanium mesh with a pore size of 40 to 160 μm, preferably 40 to 100 μm. Tissue growth is achieved when the port housing is percutaneously implanted in the patient and fine fibrous vascular tissue grows and extends into and fills the pores of the material, thereby sealing off at least the upright wall 4w of the housing 4. As a result, after sufficient healing, the tissue growth medium interface between the port and the patient's tissue surrounding the port housing forms a sterile barrier between the port and the tissue, preventing the patient from becoming infected. A more detailed explanation of the effects of pore size in porous implants is provided in the paper "Effects Of Pore Size, Implantation Time And Nano-surface Properties on Rat Skin Ingrowth Into Percutaneous Porous Titanium Implants" by Brad J. Farrell et al. (J Biomed Matter Res. A. 2014 May; 102(5); 1305-1315).

[0024]

[0040] Port 2 of the present invention can be used to inject fluid medication into a patient. During operation, Port 2 is implanted percutaneously into the patient's body 14 at a depth such that the upper part 4t of the housing 4 and the upper part 8t of the insertion part 8 are in or above the patient's skin 12, as shown in Figure 1B. Thus, the upper surface 8t of the insertion part, along with its fluid inlet 8i, is exposed to the environment. The fluid inlet 8i can be coupled to the fluid outlet 16o of the fluid storage unit 16 (shown by a dotted line in Figure 1B). The fluid storage unit 16 may be a syringe, a fluid pump, a fluid bag, a fluid collection container, or other well-known types of fluid storage devices. Port 2 can be sutured to the patient as is conventionally known. Alternatively, the port may be attached and fixed to the patient using a tissue adhesive such as 3M VETBOND tissue adhesive, or by using adhesive tape.

[0025]

[0041] An advantage of the present invention is that, because the top of the port is exposed, there is no septum to be punctured in the port of the present invention, eliminating the need to puncture the patient's skin with a needle. This allows for frequent access to the port without causing further discomfort or infection risk to the patient. Another advantage is that, because the top of the port is exposed, clinicians can accurately determine the location of the port visually. Yet another advantage is that the components of the port, other than the implanted housing, can be easily replaced after use. This is important because, conventionally, if the components of an implanted port become faulty or worn out, clinicians have to surgically remove the faulty port and replace it with a new one. However, because the top surface of the port is exposed to the environment, the insertion section and lumen can be easily replaced, and the integrity of the port components is maintained. Furthermore, because it is not necessary to locate the port, puncture the septum, and then connect the inserted needle to the fluid reservoir, as was done conventionally, procedures requiring fluid infusion into and / or fluid collection from the patient can be performed quickly.

[0026]

[0042] For example, once a procedure such as injection is completed, the insertion part 8 can be removed and replaced with a blank insertion part or plug without causing an infection risk to the port due to the disconnection of the fluid storage part from the fluid inlet 8i while leaving the insertion part 8 inside the housing 4. Furthermore, the port of the present invention may have a blank insertion part installed during shipment, and possibly during the implantation procedure. As discussed above, after the port housing has been properly implanted into the patient, the blank insertion part can be replaced with the injection insertion part. Figures 4A to 4C show the blank insertion part and its fitting into the port housing. In Figures 4A to 4C and the remaining figures of this specification, components identical to those shown in Figures 1A to 3B and described with reference to these figures are denoted by the same reference numerals.

[0027]

[0043] Referring to Figures 4A to 4C, the blank insertion portion of the plug 18 is shown. Except for the injection port, the plug 18 has the same external configuration as the insertion portion 8 and includes a cylindrical body 18a. Internally, the plug 18 is solid and has no internal passage. Externally, the plug 18 has a top surface 18t, a flange 18f extending downward from the top surface 18t and resting on a step 4s of the housing 4 when the plug 18 is fully inserted into the internal chamber 4i in a sealed state, and a slot 18g along the side wall that guides the plug 18 into the housing. Figure 4A shows the plug 18 positioned on the housing 4 and ready for insertion into the housing 4. Figure 4B shows the plug 18 fully inserted into the housing 4 in a sealed state. Figure 4C shows a cross-sectional view of the port of the present invention with the plug 18 fitted. The color of at least the top surface of the plug 18 can be matched to skin tone. An additional cover over the exposed portion of the port, which may include the outer periphery of the housing surrounding the plug, provides an additional level of protection against contamination. When port 2, as shown in Figures 1A and 4B, is implanted in a patient, the tissue growth medium 10 acts as a sterile barrier against bacteria and microorganisms at the point of contact between the housing wall and the patient's tissue, and the blank plug further prevents bacteria and microorganisms from entering the housing chamber, thereby reducing the patient's risk of infection.

[0028]

[0044] As discussed above, the components of the port of the present invention can be replaced or swapped with new ones after a single use. Replacing a contaminated lumen with a new one can be done by removing the (presumably contaminated) lumen 6 from the aperture 6p and replacing it with a new lumen, as can be seen from Figures 3A to 3B. In an alternative detachable lumen, the outer lumen or tube is fixed to the housing 4, and the inner lumen, tube, or catheter is slidably fitted along the outer lumen. If the outer lumen extends from the internal structure 4f of the housing 4, the detachable inner lumen may have a component similar to the flange 6f at its proximal end. This allows the outer lumen to guide the distal end of the inner catheter fitted along it to the selected site in the patient where fluid injection or extraction is performed. After the procedure is complete, the used inner catheter can be replaced with a new one.

[0029]

[0045] Figures 5A and 5B illustrate alternative embodiments of the port of the present invention in which multiple passages are provided within the insertion plug to establish multiple fluid pathways. In the illustrated exemplary embodiment, the insertion portion 8' of the port 2' has two fluid passages 8'p1 and 8'p2 connected to fluid inlets 8'i1 and 8'i2, respectively, on the upper surface of the insertion portion 8'. The passages 8'p1 and 8'p2 have outlets 8'o1 and 8'o2 aligned with corresponding proximal openings 6'o1 and 6'o2 of lumens 6'a and 6'b in the base 4'b of the housing 4'. The exemplary multiple lumen ports may be used in procedures such as dialysis in which separate fluid pathways are required for fluid infusion into and fluid collection from the patient. Although illustrated to have two fluid pathways, the insertion portion of the present invention may be configured to have three or more passages as needed, and possibly by increasing the dimensions of the plug and housing. As discussed above, the tissue internal growth medium group 10 surrounds the wall 4'a of the housing 4', establishing a sterile barrier that prevents infection in the patient.

[0030]

[0046] The insertion portion, whether an injection plug or a plug, is provided with an exemplary locking mechanism to ensure that it does not accidentally detach from the port housing. Once the insertion portion is engaged with the housing, it secures and maintains both the insertion portion and the housing until the insertion portion is intentionally removed from the housing. The locking mechanism will be described with reference to Figures 6A to 6F, which illustrate the port of the present invention having a plug fitted into a housing as shown in Figures 4B to 4C. In Figures 6A to 6F, the same components as those shown in Figures 4B to 4C are indicated by the same reference numerals.

[0031]

[0047] As shown in Figure 6A, the upper surface 18t of the plug 18 has an orifice that opens into the hole 20. The hole 20 has a semicircular cross-sectional configuration that matches the curvature of the outer surface of the cylindrical body 18a of the plug 18. The hole 20 extends longitudinally along the side wall of the insertion portion 18 and is offset from the flange 6f of the lumen 6, so it does not affect the joint guidance relationship between the flange 6f and the slot 18g as discussed above.

[0032]

[0048] As shown in Figure 6B, the hole 20 extends from the top surface 18t to a depth beyond the position of the wall 4w of the housing 4 in the area defined by the dotted circle C. Figure 6D shows an enlarged view of circle C, illustrating a cavity 4c that houses a biasing element 4q, which is a spring that biases the rear surface 4ls1 of the main body of the cantilever member 4l. The member 4l has a first leg 4l1 that is slidably supported within the channel 4n, and a second leg 4l2 in the opposite direction that is adapted to move bidirectionally in and out of the opening 4h1 in the inner wall 4iw, as indicated by the directional arrow 24. A ball bearing or roller ball 4r is in contact with the front surface 4ls2 of the cantilever member 4l at a position opposite to the biasing element 4q. The ball 4r is adapted to move bidirectionally in and out of the interior 4i of the housing 4 through the opening 4h2. Member 4l, biasing element 4q, and ball 4r can all be considered as the first locking portion of the port locking mechanism of the present invention. Figure 6D shows that when there is no insertion portion in the chamber 4i, the ball 4r and leg 4l2 each extend from the wall 4iw of the housing 4 into the internal chamber 4i. The dimensions of the components shown in Figure 6D and Figures 6E to 6F discussed below may be exaggerated to better illustrate the present invention and may not be to a constant scale.

[0033]

[0049] Figure 6E shows the plug 18 engaging into the chamber 4i of the housing 4 in the direction of the directional arrow 26. The insertion portion 18 includes a hole 20, as discussed above with reference to Figures 6A to 6B. Furthermore, there is a notch 18n near the bottom 20b of the hole 20. The position of the notch 18n along the insertion portion 18 is predetermined so that the notch 18n receives the leg 4l2 when the ball 4r is sufficiently biased into the hole 20 by the biasing element 4q, as shown by the solid line in Figure 6F. The notch 18n can be considered a second locking element of the port locking mechanism of the present invention. As shown in Figure 6E, when the insertion portion 18 is moved along the direction indicated by the directional arrow 26, the outer surface of the side wall 18w contacts the ball 4r and biases the ball 4r in the direction indicated by the directional arrow 28, so that both the ball 4r and the leg 4l2 remain retracted into the cavity 4c. As long as the inner wall 4iw and the side wall 18w are in sliding contact with each other, the ball 4r and the leg 4l2 remain within the cavity 4c. The gap shown between the surface of the inner wall 4iw and the outer surface of the wall 18w of the housing 4 in Figure 6E (and Figure 6F) is for illustrative purposes only, and in reality, depending on the allowable tolerances for sealing, the walls of the housing and the insertion part may be in sliding contact with each other.

[0034]

[0050] Figure 6F shows the insertion part 18 fully engaged within the internal chamber 4i of the housing 4. As shown, the ball 4r moves from a retracted position, as indicated by the dotted line, to a position partially inside the hole 20 along the direction indicated by the directional arrow 30. Accordingly, the front end of the leg 4l2 is positioned inside the notch 18n, so that the positions of the ball 4r and leg 4l2 are as shown in Figure 6D. As a result, the insertion part 18 and the housing 4 are fixed and held or maintained relative to each other, making it impossible for the insertion part to be accidentally removed from the housing. The same exemplary locking mechanism can be provided to the injection insertion part to prevent accidental removal from the port housing.

[0035]

[0051] To remove the exemplary plug 18 (or locked injection insertion 8) from the housing 4, an exemplary removal tool, as shown in Figures 7A to 7B, can be used. Specifically, the tool 22 is illustrated to have a handle 22a and a body 22b, each slightly curved to match the curvature of the hole 20. The length of the tool 22 is such that its distal end 22d contacts the bottom 20b of the hole 20, preventing the tool 22 from moving further downward. The fingers 22f, in their natural state, point away from the body 22b and extend to the opposite side of the space 22s of the body 22b, at a position directly below the bottom surface 18fb of the flange 18f (Figure 6C) when the tool 22 is fully inserted into the hole 20. Therefore, as the tool 22 is inserted into the hole 20, the finger 22f is pushed into the space 22s by the inner wall 4iw, but once the tip of the finger 22f has passed the bottom surface 18fb of the flange 18f, the finger 22f returns to its natural position below the bottom surface 18fb, as shown in Figure 6C. When the finger 22f contacts the bottom surface 18fb, or immediately before, the distal part of the body 22b contacts the ball 4r, biasing the ball 4r and the leg 4l2 into the cavity 4c of the housing 4. The plug 18 can then be removed by pulling the tool 22 upward with the handle 22a. The removed insertion part can be discarded together with the tool 22. An exemplary locking mechanism or an injection insertion part having a similar locking mechanism can be removed in the same manner. The tool 22 must be made available only to clinicians or nurses to prevent tampering with the port.

[0036]

[0052] Figures 8A and 8B show another embodiment of the insert of the present invention that can be used without the need to remove and replace the blank insert when injecting into a patient. As shown, the insert 32 has an upper part 32a with an upper passage 32pu and a lower part 32b with a lower passage 32pl, which are rotatable relative to each other about a central shaft 32s. For consideration, we assume that the passages 32pu and 32pl are longitudinally offset from the central axis 32x of the insert 32, and that the shaft 32s extends along the longitudinal central axis 32x. In this embodiment, only the lower part 32b has a guide slot, and the flange 6f of the housing 4 has a height that matches the height of the guide slot of the lower part 32b. Thus, after being fully engaged in a sealed state with respect to the internal chamber of the housing 4, the upper part 32a becomes rotatable relative to the lower part 32b. The lower part 32b includes a fluid outlet that remains aligned in a sealed state with respect to the lumen inlet. To rotate the upper part 32a, a torque greater than a predetermined force is applied to the upper part 32a to overcome the friction and sealing contact that prevents the upper and lower parts from rotating freely relative to each other. Thus, during injection, the upper and lower passages 32pu and 32pl are aligned as shown in Figure 8A, and the insertion part 32 operates similarly to the insertion part 8. At the end of the injection procedure, or during a temporary interruption of injection, the upper part 32a is held by the integral part of the injection inlet and can be rotated, for example, 90 degrees counterclockwise relative to the lower part 32b to position the fluid inlet toward the plane of the paper, as shown in Figure 8B. As a result, the upper passage 32pu and the lower passage 32pl are no longer aligned relative to each other. This is shown in Figure 8B, where the upper passage 32pu is hidden from view. The upper part 32a can be rotated back to the position shown in Figure 8A when injection is to be resumed.

[0037]

[0053] Since the present invention is subject to numerous modifications, alterations, and changes in detail, all matters described herein and illustrated in the accompanying drawings are intended to be interpreted as illustrative only and not as limiting. For example, instead of the mechanical locking mechanism described above, other locking mechanisms may include, for example, magnets, which can be attached to the blank insertion portion to allow for magnetic removal, or electronic devices, which may include smart devices available only to clinicians to deactivate the port locking mechanism. The insertion portion may also be fitted into the housing by screw fastening. In this case, threads corresponding to the outer wall of the insertion portion and the inner wall of the housing chamber are formed. Accordingly, the present invention is intended to be limited only to the spirit and scope of the appended claims.

Claims

1. a housing having an interior defined by a bottom, a non-terminating wall, and a top, the top having an opening that opens to the interior of the housing; at least one aperture at a selected location through said non-terminated wall; an insert having a top surface and a cross-sectional dimension that allows the insert to engageably fit within the interior of the housing through the opening in the housing, the top surface being in a substantially planar relationship with the top of the housing after insertion into the housing; wherein the housing is adapted to be implanted into a body with the top surface of the insertion portion exposed to the environment.

2. 2. The port of claim 1, wherein the insert has a passageway extending from the top surface to an outlet in a side wall of the insert that is sealingly aligned with the aperture to establish a fluid path between the top surface of the insert and the aperture when the insert is fitted into the housing.

3. 3. The port of claim 2, further comprising a lumen having a proximal end removably attached to the aperture and a distal end extending away from the housing and adapted to be selectively positioned at a location within the body to output fluid to the location.

4. 3. The port of claim 2, further comprising a tube extending from the aperture away from the housing, the tube adapted to removably receive a catheter slidably extending therethrough, the catheter having a distal end selectively positionable at a location within the body, the catheter being removable from the tube once used and replaced with another catheter.

5. 3. The port of claim 2, wherein the passage in the top surface of the insert has an inlet fluidly connected to the passage for receiving an outlet of a fluid reservoir, thereby allowing fluid from the fluid reservoir to be passed through the passage in the insert and injected into a selected location within the body via a lumen having a proximal end attached to the aperture aligned with the outlet of the insert and a distal end positioned at the selected location.

6. 10. The port of claim 1, wherein the non-terminated wall has an outer surface, and the port further comprises a tissue ingrowth medium surrounding at least the outer surface of the non-terminated wall and permitting tissue growth around the non-terminated wall, thereby forming a sterility barrier at the location of contact between the non-terminated wall and the body tissue surrounding the non-terminated wall.

7. 2. The port of claim 1, wherein the insert is a blank plug that seals the interior of the housing when the port is not being used for injection, and an injection plug when the port is being used for injection, the injection plug having at least one inlet on a top surface, at least one passageway extending from the one inlet to at least one outlet aligned with the one aperture to establish at least one fluid pathway from the one inlet to the one aperture, and a lumen extending from the one aperture and positionable at a selected location within the body to direct fluid input to the one inlet to the selected location.

8. 2. The port of claim 1, wherein the insert fitted to the housing has a fixed lower portion and an upper portion rotatable relative to the lower portion, and a through passage extending from a fluid inlet in the top surface through the upper and lower portions to the one aperture, the passage forming a fluid path from the fluid inlet to the one aperture when the upper and lower portions are aligned with each other, and the fluid path being interrupted when the upper portion is rotated to a position where it is not aligned with the lower portion so that the upper and lower portions are not aligned with each other.

9. 10. The port of claim 1, further comprising locks on the insert and the housing that prevent tampering with the insert and the housing or inadvertent separation of the insert and the housing after the insert is fully engaged with the housing.

10. 1. A port adapted to be implanted within a body while leaving a portion visually visible, comprising: a housing having an interior defined by a bottom, a non-terminating wall having an exterior surface, and a top, the top having an opening that opens to the interior of the housing; at least one lumen extending away from the housing from at least one aperture in the non-terminated wall; an insert having a top surface and a cross-sectional dimension that allows the insert to engageably fit within the interior of the housing through the opening in the housing; wherein the housing of the port is implantable into the body to a depth that remains external to the body or at skin level so that the top surface of the insertion portion is visually visible.

11. 11. The port of claim 10, further comprising a tissue ingrowth medium surrounding at least the outer surface of the non-terminated wall to form a sterility barrier at the location of contact between the non-terminated wall of the implanted housing and tissue of the body.

12. 11. The port of claim 10, wherein the insert has a passageway extending from an inlet in the top surface to an outlet in a side wall of the insert aligned with the one aperture, establishing at least one fluid path between the inlet and the one lumen extending from the one aperture when the insert is fitted into the housing.

13. 11. The port of claim 10, wherein the insert has at least two passages extending from two fluid inlets in the top surface to two outlets in the insert, the two outlets being aligned with two corresponding apertures in the housing to establish at least two fluid paths between the two fluid inlets and two corresponding lumens when the insert is fitted to the housing, each of the two corresponding lumens extending from a corresponding one of the apertures.

14. 11. The port of claim 10, wherein the lumen comprises a lumen having a proximal end removably secured to the one aperture and a distal end extending away from the housing for selective positioning at a location within the body.

15. 11. The port of claim 10, wherein the lumen includes a catheter slidably fitted along a tube secured to one of the apertures, the catheter having a distal end selectively positionable at a location within the body, the catheter being removable from the tube once used and replaced with another catheter.

16. 13. The port of claim 12, wherein the proximal end of the one lumen is removably secured to the one aperture and includes a flange removably engaged in a slot in the inner surface of the non-terminated wall, the flange acting as a guide for fitting the insert into the interior of the housing and preventing relative movement of the insert with respect to the housing, thereby maintaining alignment of the outlet of the insert and the proximal end of the lumen after the insert is fitted into the housing.

17. 11. The port of claim 10, wherein the insert is a blank plug that seals the interior of the housing when the port is not used for infusion, and an infusion plug when the port is used for infusion, the infusion plug having an inlet and a passageway in a top surface, the passageway extending from the inlet to an outlet in sealing alignment with the one aperture to establish a fluid pathway from the inlet to the one lumen extending from the aperture.

18. A port that is visually visible and accessible to the environment after implantation, a housing having an interior defined by a bottom, a non-terminating wall having an exterior surface, and a top, the top having an opening that opens to the interior of the housing; at least one lumen extending from at least one aperture in said non-terminated wall; a tissue ingrowth medium surrounding the outer surface of the non-terminated wall; an insert having a top surface and a cross-sectional dimension that fits into the interior of the housing through the opening in the housing in an engaging manner; wherein the housing of the port is implantable into the body to a depth that maintains the top surface of the insertion portion accessible to the environment; After implantation into the body, the tissue ingrowth medium forms a sterile barrier between the non-terminal wall and the body tissue surrounding the wall.

19. 20. The port of claim 18, wherein the insert is a blank plug that seals the interior of the housing when the port is not used for infusion, and an infusion plug when the port is used for infusion, the infusion plug having at least one inlet and at least one passageway in a top surface, the at least one passageway extending from the one inlet to at least one outlet in sealing alignment with the one aperture to establish at least one fluid pathway from the one inlet to the one lumen extending from the one aperture.

20. 19. The port of claim 18, wherein the insert has a first passageway extending from a first inlet in the top surface through a first outlet in the insert aligned with the one aperture to the one lumen, and a second passageway extending from a second inlet in the top surface through a second outlet in the insert aligned with another aperture in the non-terminated wall to another lumen extending from the other aperture, thereby providing two passageways when the insert is mated with the housing.

Images