US20040064110A1 - Injection port - Google Patents

Abstract

An injection port and implantable pump for adding fluid to, or withdrawing fluid from, a surgical implant inside a patient's body is disclosed. Also disclosed is a surgical method for treating diseases using the injection port and pump. The injection port and implantable pump includes a rigid base member and an injection membrane penetrable by an injection needle and attached to the base member. The membrane and base member define a chamber for holding fluid. The membrane is displaceable relative to the base member between a first position in which the volume of the fluid chamber is maximal and a second position, in which the volume of the chamber is minimal. According to the method, the membrane is manually displaced from time to time to distribute fluid between the fluid chamber of the injection port and the implant to operate the implant, which is typically a hydraulic restriction device. The implant can be designed for treating reflux disease, urinary incontinence, impotence, anal incontinence or obesity.

Description

FIELD OF THE INVENTION
• The present invention relates to an injection port and an implantable pump for adding fluid to, or withdrawing fluid from, a surgical implant inside a human body. The present invention also relates to surgical methods for treating diseases using the injection port and pump.[0001]
BACKGROUND
• Traditional so called injection ports are used for post-operation adjustments of hydraulic implants. The injection port comprises a thick wall member of silicone mounted under tension to create a membrane through which it is possible to inject a specific type of needle for injecting hydraulic fluid into the interior of the port, without afterwards creating leakage through the membrane. The needle has a lateral opening and does not cut out any remaining hole in the silicone membrane. It just moves the silicone aside. The silicone membrane of traditional injection ports comprises a relatively hard (typically a hardness of about 60 Shore) and thick solid silicone. Since the thickness of the membrane normally is about 6 mm for a normal-sized injection port, it is difficult to find a proper location in the patient for subcutaneous implantation of the injection port. Besides, traditional injection ports are not suited for hydraulically adjustable implants that need to be adjusted frequently, i.e., several times a day.[0002]
SUMMARY OF THE INVENTION
• An object of the present invention is to provide an injection port and an implantable pump, which are thinner and smaller than those of the prior art, and, therefore, more easily implanted subcutaneously. Another object of the present invention is to provide an injection port and an implantable pump, which are more versatile than those of the prior art. A further object of the present invention is to provide an injection port and an implantable pump that are easy and cheap to manufacture. Yet another object of the present invention is to provide surgical methods by using an injection port.[0003]
• Accordingly, in accordance with a first aspect of the present invention, there is provided an injection port for adding fluid to, or withdrawing fluid from, a surgical implant inside a human body, the injection port comprising a rigid base member, and an injection membrane attached to the base member, the membrane and the base member defining a chamber for fluid, wherein the membrane includes a first layer and a second layer attached to each other, the first layer having better strength properties than the second layer and the second layer having better sealing properties than the first layer.[0004]
• As a result, the thickness of the membrane may even be halved in comparison to the membrane used in prior injection ports. For example, the thickness of the membrane of the injection port of the present invention may be as small as about 3 mm. Furthermore, if the membrane is designed with a shorter diameter, it can be even thinner. Thus, since the thickness of the membrane can be substantially decreased in comparison to prior art, the injection port of the present invention can also be designed to be small and thin.[0005]
• Another advantage obtained by the injection port of the present invention is that it also works as a small pump, which can be manually operated.[0006]
• The membrane layers of the present invention may be made of silicone, wherein the first silicone layer is harder than the second silicone layer. The second layer silicone suitably has a hardness less than 20 Shore. Generally, the second layer is situated between the first layer and the chamber of the injection port. Alternatively, the membrane may comprise a third layer harder than the second layer, wherein the third layer is situated between the second layer and the chamber.[0007]
• The membrane is suitably displaceable, preferably manually, relative to the base member between a first position, in which the volume of the chamber is maximal, and a second position, in which the volume of the chamber is minimal. The membrane is preferably elastic and may take the shape of a semi-sphere, when it is in the first position. Accordingly, when the membrane is displaced to the second position it is substantially flattened and in a state of tension.[0008]
• The injection port may further comprise a locking device adapted to releaseably lock the membrane in the second position. Thus, the membrane may be displaced from the first position to the second position by manually depressing the membrane. Moreover, the locking device can be adapted to release the membrane from the second position upon pushing the membrane, whereby the membrane resumes its semi-spherical shape in the first position.[0009]
• In accordance with a second aspect of the present invention, there is provided an implantable pump for pumping fluid to and from a surgical implant inside a human body, comprising a rigid base member, and an injection membrane penetrable by an injection needle and attached to the base member, the membrane and the base member defining a chamber for fluid, wherein the membrane is displaceable relative the base member between a first position, in which the volume of the chamber is maximal, and a second position, in which the volume of the chamber is minimal, whereby the amount of fluid that is to be pumped between the chamber and the surgical implant can be calibrated by inserting an injection needle through the injection membrane and adding fluid to or withdrawing fluid from the chamber.[0010]
• The injection membrane of the implantable pump may be designed as the membrane discussed above in connection with the injection port of the invention[0011]
• In accordance with a third aspect of the present invention, there is provided a method for hydraulically operating a surgical implant implanted in a patient, the method comprising: subcutaneously implanting in the patient an injection port having a displaceable injection membrane for changing the volume of a fluid chamber in the injection port; hydraulically connecting the injection port to the surgical implant; calibrating the amount of fluid in the fluid chamber of the injection port by penetrating the patient's skin and the membrane of the injection port with an injection needle and adding fluid to or withdrawing fluid from the fluid chamber; and from time to time, manually displacing the membrane of the subcutaneously implanted injection port, in order to distribute fluid between the fluid chamber of the injection port and the implant to operate the implant.[0012]
• In accordance with a fourth aspect of the present invention, there is provided a surgical method for treating a patient having a disease, comprising the steps of: insufflating the patient's abdomen with gas; placing at least two laparoscopical trocars in the human's body; inserting at least one dissecting tool through the trocars and dissecting a region of the patient; implanting an implant designed for treating reflux disease, urinary incontinence, impotence, anal incontinence or obesity, in the dissected area by using surgical instruments through the trocars; subcutaneously implanting in the patient an injection port having a displaceable injection membrane for changing the volume of a fluid chamber in the injection port; hydraulically connecting the injection port to the surgical implant; calibrating the amount of fluid in the fluid chamber of the injection port by penetrating the patient's skin and the membrane of the injection port with an injection needle and adding fluid to or withdrawing fluid from the fluid chamber; and from time to time, manually displacing the membrane of the subcutaneously implanted injection port, in order to distribute fluid between the fluid chamber of the injection port and the implant to operate the implant.[0013]
• The above described apparatuses and methods may also be designed for treating reflux disease, urine incontinence, impotence, anal incontinence or obesity or the like.[0014]
BRIEF DESCRIPTION OF THE DRAWINGS
• A preferred embodiment of the present invention will now be described by way of example, with reference to the attached drawings, by no way restricting the present invention thereto, wherein[0015]
• FIG. 1 shows an injection port according to the prior art.[0016]
• FIG. 2 illustrates an injection port according to the present invention, where a needle has been injected through the membrane.[0017]
• FIG. 3 shows the injection port of FIG. 2 working as a hand driven pump.[0018]
• FIG. 4 shows the injection port of FIG. 2 working as a hand driven pump, where the membrane is in its lowest position.[0019]
• FIG. 5 is a schematic view of an implantable hydraulic restriction device for use together with the injection port of the invention, designed for treating reflux disease, urine incontinence, anal incontinence or obesity.[0020]
DETAILED DESCRIPTION OF THE INVENTION
• FIG. 1 shows a traditional injection port[0021]1 according to the prior art, which has a housing2 mounted on abase3 and a membrane4 made of solid silicone covering an opening in housing2. Typically, the silicone used to make membrane4 has a hardness of 60 Shore or more. The thickness of membrane4 is normally about 6 mm for a normal-sized injection port.
• FIG. 2 shows an[0022]injection port10 according to the present invention, where aneedle12 of asyringe14 has been injected through amembrane16 attached to arigid base member18 of theinjection port10. According to the embodiment shown in FIG. 2,membrane16 has a semi-spherical shape in its initial, “non-depressed” position, as shown in FIG. 2. In the embodiment shown in FIGS.2-4,membrane16 is comprised of three layers attached to each other: a firsthard layer20 having preferably a hardness of more than 20 Shore; a second softcentral layer22 having a hardness of less than 20 Shore; and a thirdhard layer24, having a hardness suitably more than 20 Shore, but preferably about 60 Shore or more.Membrane16 andbase member18 define achamber25 for fluid. However, in the most general embodiment of the injection port of the present invention, it is sufficient ifmembrane16 comprises two layers, i.e., one first hard layer and one second soft layer betweenchamber25 andfirst layer20.First layer20 has better strength properties thansecond layer22, andsecond layer22 has better sealing properties thanfirst layer20.Membrane16's layers are suitably made of plastic or silicone, and preferably of silicone. Suitable silicon materials are manufactured by “Applied Silicone, Inc.”
• FIGS. 3 and 4[0023]show injection port10 of FIG. 2 working as a hand driven pump. By using a core formembrane16 that is very soft, i.e., elastic silicone material of less than 20 shore, it is possible to create a thinner and more elastic membrane that could be pumped by hand and still not cause leakage when aneedle12 of asyringe14 penetrates the membrane. FIG. 3 illustrates a finger26 pushing (actuated by one push)membrane16 in adirection28 from above.Membrane16 will then be substantially flattened, such that the surface that is faced against the finger26 will assume a somewhat concave bowl-shape30.Membrane16 is then moved to a lowest position, as shown in FIG. 4, where it is held by alocking device32 until it is manually pressed again. Whenmembrane16 is actuated again, by a second push by the finger26, the locking device32 (which functions similar to the locking mechanism for a ballpoint pen) releasesmembrane16, wherebymembrane16 is able to return to its regular convex-shaped condition as shown in FIG. 2.
• FIG. 5 shows an example of an implantable[0024]hydraulic restriction device41 comprising aband40 formed into a loop around a patient's rectum (not shown), so thatrestriction device41 may function as an artificial sphincter.Band40 includes acavity42, which can be hydraulically connected to aninjection port10 of the invention. By usinginjection port10, hydraulic fluid may be supplied toband40 toinflate cavity42, in order to close the rectum, and be withdrawn from theband40 to deflate thecavity42, to open the rectum. This type of restriction device, when combined withinjection port10 of the present invention, may also be used as an artificial sphincter for treating patients suffering from heartburn and reflux disease or urinary incontinence.Restriction device41 may also be combined withinjection port10 for the purpose of forming an adjustable constricted stoma opening in the stomach or esophagus of an obese patient to treat obesity or for restricting the penile exit blood flow of an impotent patient.
• According to the method of using[0025]injection port10 to treat various diseases, afterinjection port10 is subcutaneously implanted in the patient,displaceable injection membrane16 is used to pump fluid influid chamber25 to surgical implantedrestriction device41, which is hydraulically connected toinjection port10. The amount of fluid influid chamber25 capable of being pumped torestriction device41 usinginjection port10 is calibrated by penetrating the patient's skin andmembrane16 ofinjection port10 withinjection needle12 ofsyringe14 to add or withdraw fluid fromchamber25.Membrane16 is manually displaced from time to time to pump the fluid fromchamber25 ofinjection port10 to implant41 to operate the implant.
• To insert in a patient an implant-like[0026]hydraulic restriction device41, the patient's abdomen is insufflated with gas, after which at least two laparoscopical trocars are placed in the patient's body. At least one dissecting tool is then inserted through the trocars to dissect a region of the patient to implant in the dissected area using surgical instruments through the trocars the particular implant that is designed for treating the particular disease to be treated.
• Although the present invention has been described in terms of a particular embodiment and process, it is not intended that the invention be limited to that embodiment. Modifications of the embodiment and process within the spirit of the invention will be apparent to those skilled in the art. The scope of the invention is defined by the claims that follow.[0027]

Claims (26)

What is claimed is:

1. An injection port for adding fluid to or withdrawing fluid from a surgical implant inside a human body, the injection port comprising a rigid base member, and an injection membrane attached to said base member, said membrane and said base member defining a chamber for fluid, wherein said membrane includes a first layer and a second layer attached to each other, said first layer having better strength properties than said second layer and said second layer having better sealing properties than said first layer.

2. An injection port according toclaim 1, wherein said first layer is harder than said second layer.

3. An injection port according toclaim 2, wherein said second layer is situated between said first layer and said chamber.

4. An injection port according toclaim 3, wherein said membrane comprises a third layer harder than said second layer, said third layer being situated between said second layer and said chamber.

5. An injection port according toclaim 2, wherein said second layer is made of silicone having a hardness of less than 20 Shore.

6. An injection port according toclaim 1, wherein said membrane is displaceable relative to said base member between a first position, in which a volume of said chamber is maximal, and a second position, in which the volume of said chamber is minimal.

7. An injection port according toclaim 6, wherein said membrane is manually displaceable between said first and second positions.

8. An injection port according toclaim 6, further comprising a locking device adapted to releaseably lock said membrane in said second position.

9. An injection port according toclaim 6, wherein said membrane is elastic and takes the shape of a semi-sphere, when it is in said first position.

10. An injection port according toclaim 9, wherein said membrane is substantially flattened, when it is in said second position.

11. An injection port according toclaim 10, further comprising a locking device adapted to releaseably lock said membrane in said second position, when said membrane is pushed from said first position to said second position.

12. An injection port according toclaim 11, wherein said a locking device is adapted to release said membrane from said second position upon pushing said membrane, whereby said membrane resumes its semi-spherical shape in said first position.

13. An implantable pump for pumping fluid to and from a surgical implant inside a human body, comprising a rigid base member, and an injection membrane penetrable by an injection needle and attached to said base member, said membrane and said base member defining a chamber for fluid, wherein said membrane is displaceable relative said base member between a first position, in which the volume of said chamber is maximal, and a second position, in which the volume of said chamber is minimal, whereby the amount of fluid that is to be pumped between said chamber and the surgical implant can be calibrated by inserting an injection needle through said injection membrane and adding fluid to or withdrawing fluid from said chamber.

14. An implantable pump according toclaim 13, wherein said membrane is manually displaceable between said first and second positions.

15. An implantable pump according toclaim 13, further comprising a locking device adapted to releaseably lock said membrane in said second position.

16. An implantable pump according toclaim 13, wherein said membrane is elastic and takes the shape of a semi-sphere, when it is in said first position.

17. An implantable pump according toclaim 16, wherein said membrane is substantially flattened, when it is in said second position.

18. An implantable pump according toclaim 17, further comprising a locking device adapted to releaseably lock said membrane in said second position, when said membrane is pushed from said first position to said second position.

19. An implantable pump according toclaim 18, wherein said locking device is adapted to release said membrane from said second position upon pushing said membrane, whereby said membrane resumes its semi-spherical shape in said first position.

20. An implantable pump according toclaim 13, wherein said membrane includes a first layer and a second layer attached to each other, said first layer having better strength properties than said second layer and said second layer having better sealing properties than said first layer.

21. An implantable pump according toclaim 20, wherein said first layer is harder than said second layer.

22. An implantable pump according toclaim 21, wherein said second layer is situated between said first layer and said chamber.

23. An implantable pump according toclaim 22, wherein said membrane comprises a third layer that is harder than said second layer, said third layer being situated between said second layer and said chamber.

24. An implantable pump according toclaim 21, wherein said second layer is made of silicone having a hardness of less than 20 Shore.

25. A method for hydraulically operating a surgical implant implanted in a patient, the method comprising:

subcutaneously implanting in the patient an injection port having a displaceable injection membrane for changing the volume of a fluid chamber in the injection port;

hydraulically connecting the injection port to the surgical implant;

calibrating the amount of fluid in the fluid chamber of the injection port by penetrating the patient's skin and the membrane of the injection port with an injection needle and adding fluid to or withdrawing fluid from the fluid chamber; and

from time to time, manually displacing the membrane of the subcutaneously implanted injection port, in order to distribute fluid between the fluid chamber of the injection port and the implant to operate the implant.

26. A surgical method for treating a patient having a disease, comprising the steps of:

insufflating the patient's abdomen with gas;

placing at least two laparoscopical trocars in the human's body;

inserting at least one dissecting tool through the trocars and dissecting a region of the patient; implanting an implant designed for treating reflux disease, urinary incontinence, impotence, anal incontinence or obesity, in the dissected area by using surgical instruments through the trocars;

subcutaneously implanting in the patient an injection port having a displaceable injection membrane for changing the volume of a fluid chamber in the injection port;

hydraulically connecting the injection port to the surgical implant;

calibrating the amount of fluid in the fluid chamber of the injection port by penetrating the patient's skin and the membrane of the injection port with an injection needle and adding fluid to or withdrawing fluid from the fluid chamber; and

from time to time, manually displacing the membrane of the subcutaneously implanted injection port, in order to distribute fluid between the fluid chamber of the injection port and the implant to operate the implant.

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