MXPA06001266A - Surgically implantable injection port having an absorbable fastener - Google Patents

Abstract

An implantable surgical injection port having an undeployed position, and a deployed position wherein it is attached to tissue. The port includes a housing having a closed distal end, a open proximal end and a fluid reservoir therebetween. The port further includes a needle penetrable septum attached to the housing about the opening. The port even further includes at least one attachment mechanism mounted to the housing for initially attaching the port to tissue wherein the attachment mechanism is made from a bioabsorbable material.

Description

A SURGICALLY IMPLANTABLE INJECTION PORT WITH AN ABSORBABLE BRAKE FIELD OF THE INVENTION The present invention has application in conventional endoscopic and open surgical instrumentation, as well as application in robotic-assisted surgery. The present invention also relates to surgically implantable fit bands, such as gastric bands for the treatment of obesity.

BACKGROUND OF THE INVENTION The percentage of the world's population that suffers from morbid obesity is constantly increasing. Excessively obese people are susceptible to an increased risk of heart disease, stroke, diabetes, lung disease and accidents. Due to the effect of morbid obesity on the patient's life, methods are being sought to treat morbid obesity. Numerous non-operative therapies for morbid obesity have been tried with virtually no permanent success. Treatment has been tried in the diet, modification of behavior, hold the jaws of a patient through cables and pharmacological methods and have failed to correct the condition. Mechanical devices have also been used for insertion into the body by non-surgical means, such as the use of gastric balloons to fill the stomach in the treatment of the condition. However, such devices can not be used for a long term, as they frequently cause severe irritation, which requires periodic removal and therefore interruption of treatment. Thus, the medical community has evolved towards surgical approaches for the treatment of morbid obesity. Most surgical procedures for the treatment of morbid obesity can be classified in general as directed towards the prevention of food absorption (malabsorption) or the restriction of the stomach to make the patient feel full (gastric restriction). Gastric bypass is the most common technique for malabsorption and gastric restriction. In variations of this technique, the stomach is divided horizontally into two isolated bags, with the upper bag having a small capacity for food. The upper pouch is connected to the small intestine, or jejunum, through a small stoma, which restricts food processing due to the greatly reduced usable stomach. Since food does not pass through much of the intestines, the amount of food absorption is greatly reduced. There are many disadvantages of the previous procedure. Typically the above mentioned procedure is performed in an open surgical environment. The minimally invasive techniques of today are difficult to master by surgeons, and have many additional disadvantages. In addition, there is a high level of patient concern with the idea that such a drastic procedure is not easily reversible. Additionally, all malabsorption techniques involve ongoing risks and side effects in the patient, including malnutrition and post-gastrectomy syndrome. Consequently, many patients and physicians prefer to undergo a gastric restriction procedure for the treatment of morbid obesity. One of the most common procedures involves the implantation of an adjustable gastric band. Examples of an adjustable gastric band can be found in U.S. Pat. 4,592,339 granted to Kuzmak; RE 36176 granted to Kuzmak; 5,226,429 awarded to Kuzmak; 6,102,922 awarded to Jacobson and 5,601,604 granted to Vincent, all of which are incorporated herein by reference. In accordance with current practice, a gastric band is operatively placed to surround the stomach. This divides the stomach into two parts with a stoma between them. An upper portion or bag, which is relatively small, and a lower portion that is relatively large. The small divided portion of the stomach becomes in fact the patient's new stomach, which requires very little food to make the patient feel full. Once placed around the stomach, the ends of the gastric band are held together and the band is securely held in place by bending a portion of the gastric wall over the band and closing the folded tissue with sutures placed through the stomach. of it, thus preventing the band from sliding and expanding the surrounded stoma. Gastric bands typically include a flexible substantially non-extensible portion having an expandable inflatable portion fixed thereto. The inflatable portion is in fluid communication with a remote injection site, or port. Injection or removal of an inflation fluid in or from the interior of the inflatable portion is used to adjust the size of the stoma either during or after the implant. By lengthening the stoma, the patient can eat more food without feeling full, but will not lose weight so quickly. When reducing the stoma size, the opposite happens. Doctors regularly adjust the size of the stoma to adjust the speed of weight loss. Most of the fluid injection ports for the bands described above are fixed below the skin to the patient's fascia. Such ports are often provided with suture holes and the port is sutured to the tissue. However, alternative means to fix the port to the patient, such as using integral hooks, can also be used. Said other means for fixing the port to a patient are described in the patent application of E.U.A. Commonly assigned and co-pending, Serial No. 10/741, 785 filed on December 19, 2003; 60 / 478,763 filed on December 19, 2003; 10/741, 868 filed on December 30, 2003; all of which are incorporated by reference herein. However, many of the fasteners of the prior art can cause discomfort to the patient, including pain. It is well known that once the port is placed a fibrotic capsule grows over the port until it is fully encapsulated. The speed at which the fibrotic capsule grows varies from patient to patient, but generally surgeons agree that the port is fully encapsulated after two months. Once the port has been captured by the fibrotic capsule, there is no need to hold a port with sutures or other types of fasteners. In fact, it may be convenient if these additional fastener means will no longer form part of the port system so as not to cause discomfort to the patient.

BRIEF DESCRIPTION OF THE INVENTION In accordance with the present invention, an implantable surgical injection port is provided having an undeployed position and an unfolded position in which the tissue is fixed. The port includes a housing having a closed distal end, an open proximal end and a fluid reservoir therebetween. The port also includes a pierceable septum per needle fixed to the housing around the opening. The port further includes at least one fixing mechanism mounted to the housing to initially fix the port to the tissue where the fixing mechanism is made from a bioabsorbable material.

DETAILED DESCRIPTION OF THE DRAWINGS The novel features of the invention are set forth with particularity in the appended claims. However, the invention itself, both in organization and methods of operation, together with additional objects and advantages thereof, will be better understood by reference to the following description, taken in conjunction with the accompanying drawings in which: Figure 1 is a perspective view of a surgically implantable fluid port made in accordance with the present invention, which shows the fixed port to an adjustable gastric band. Figure 2 is a perspective view of a port of surgically implantable fluid made in accordance with the present invention. Figure 3 is a cross-section of the port shown in Figures 1 and 2, taken along line 3-3 in Figure 1. Figure 4 is a view similar to that of Figure 3 but showing the port of fluid implanted within a patient.

DETAILED DESCRIPTION OF THE INVENTION With reference now to the drawings in which similar numbers indicate the same elements through the views, as stated above, an adjustable gastric band 1 of the type described in the aforementioned incorporated references is shown in Figure 1. The band 1 is implanted within a body of a patient to surround the stomach 12. The inflatable portion of the band is in fluid communication with the injection port 10 via a catheter tube 52. The tube 52 has a proximal end 53 fixed to port 10 and a distal end 55 fixed to an adjustable gastric band 1. Port 10 can be used for a wide range of devices in the medical field and not only for gastric bands. For example, the port can also be used for vascular access for drug delivery. As seen from Figures 2 and 3, the surgically implantable injection port 10 includes a housing 12. The housing 12 can be made from any number of materials including stainless steel, titanium, or polymeric materials. The housing 12 has a distal posterior portion or a closed distal end 14 and a perimeter wall portion 16 that extends proximally from the posterior portion 14 at an angle. The wall portion 16 defines a proximal opening or an open proximal end 18 and a fluid reservoir 20 between the opening 18 and the rear portion 14. The port includes a needle-penetrable septum 22 fixed to the housing around the opening 18 to cover the opening and sealing the reservoir 20. The septum 22 can be made from any number of materials including silicone. The septum 22 is preferably placed in a sufficiently proximal position so that the depth of the reservoir 20 is sufficient to expose the open tip of a needle, such as a Huber needle so that fluid transfer can be carried out. The septum 22 is preferably arranged so that it will self-seal after being punctured by a needle and the needle is removed. In one embodiment, the septum is made of silicone that is under compression when it is fixed to the housing. The port 10 further includes a catheter tube connection element 30 in fluid communication with the reservoir 20. The port 10 is implanted in a patient and fixed to the fascia just below the skin of the patient, so that the fluid can be inserted and removed from the inflatable portion with a syringe. As seen in the figures, port 1 includes one or more fixing mechanisms 70, which take the form of an arched hook. However, for the purposes of this invention, the fixation mechanism may take the form of alternative means such as using a suture. Some of these other means for fixing the port to a patient are described in the patent application of E.U.A. Commonly assigned and co-pending serial number: 10/741, 785 filed on December 19, 2003; 60 / 478,763 filed on December 19, 2003; 10/741, 868 filed on December 30, 2003; which are incorporated by reference herein in their entirety.

As seen in the figures, port 1 includes one or more fastening mechanisms 70. The figures herein show three fixing mechanisms substantially identical and equally spaced from each other. The fastening mechanisms 70 are mounted to the housing 12 at a pivot point 80 along an outer periphery 13 of the housing 12. As seen from the figures, the fastening mechanisms 70 are arcuate hooks that pivot with respect to accommodation. The attachment mechanisms 70 have an arcuate length L extending substantially more than 90 °, and preferably at least 180 ° around the pivot point. The implantable surgical injection port 10 has a non-deployed position, shown as a solid line in Figure 3, and a deployed position, shown as the imaginary line in Figures 3 and Figure 4, where the port is fixed to the tissue. The attachment mechanisms 70 are preferably made of a bioabsorbable material including, but not limited to, one or more of the following either alone or in combination: iron, polydioxanone, polyglactin and / or polyglecaprona. The locking mechanism 70 has a fixed end 72 fixed pivotally to the housing 12 at a pivot point 80. The design allows a surgeon to use forceps and push the fastener through the tissue until the free end 74 rests against the face 75. In this way the patient is protected from the sharp end of the tip. The fixing mechanism 70 also includes a free end 74 having a sharp or pointed configuration. The housing 12 further includes at least a recessed portion 15 along its distal end 14. The recessed portion 15 is designed to receive the free end 74 of the locking mechanisms 70 when the port 1 is in its unfolded position. This design avoids any exposure of the free end to the tissue after the port has been implanted. The previously described 180 ° hook or attachment mechanisms provide advantages over hooks of 90 ° or less. As seen from Figure 4, the locking mechanism described above allows the hook to engage a larger area of tissue, and allows two blocking points to enter and subsequently exit the fascia. This provides a better sacrament from the port to the fabric. In addition, no "edge" is exposed to the patient. An additional advantage of the fastener configuration is that the fastener follows a constant radius when pushed through the tissue. By maintaining a constant radius the fastener never induces a compression force on the fascia. This can minimize pain because the bra does not "compress or squeeze" the nerves. In practice, the doctor can create an incision in the skin 110 of a patient to expose the fascia in accordance with well-known surgical techniques. Hereinafter, as seen from Figure 4, port 1 can be placed against fascia 110 of the patient with the port in its undeployed position. Hereinafter, the doctor can rotate, manually or otherwise, the locking mechanism substantially more than 90 ° and preferably at least 180 ° so that the hook enters and subsequently exits the fascia. The design allows a surgeon to use forceps and push the fastener through the tissue until the free end 74 rests against the face 75. In this way the patient is protected from the sharp end of the tip. This can be done for each fixing mechanism in the device. Hereinafter, the catheter tube 52 can be connected to the connecting element 30, and the patient can be sewn closed. It will be readily apparent to those skilled in the art that the above invention applies equally to other types of implantable bands. For example, the bands are used for the treatment of fecal incontinence. Said band is described in the patent of E.U.A. 6, 461, 292 which is incorporated herein by reference. The bands can also be used to treat urinary incontinence. Said band is described in the patent application of E.U.A. 2003/0105385 which is incorporated herein by reference. The bands can also be used to treat heartburn and / or acid reflux. Said band is described in the patent of E.U.A. 6,470,892 which is incorporated herein by reference. The bands can also be used to treat impotence. Said band is described in the patent application of E.U.A. 2003/0114729 which is incorporated herein by reference. Although preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes and substitutions will occur to those skilled in the art without departing from the invention. For example, as will be apparent to those skilled in the art, the descriptions herein have equal application in robotic-assisted surgery. Furthermore, it should be understood that each structure described above has a function and said structure can be mentioned as a means to perform that function. Also, it is intended that the invention be limited only by the spirit and scope of the appended claims.

Claims (19)

NOVELTY OF THE INVENTION CLAIMS

1. - An implantable surgical injection port having an undeployed position, and a deployed position where it is fixed to the tissue, said port comprising: a) a housing having a closed distal end, an open proximal end and a fluid reservoir between the same; b) a penetrable septum with a fixed needle to said housing around said opening; and c) at least one attachment mechanism mounted to said housing for initially fixing said port to the tissue, said fixation mechanism comprising a bioabsorbable material.

2. The injection port according to claim 1, further characterized in that said fixing mechanism comprises an arcuate hook that moves in pivot with respect to said housing, said hook has a fixed end attached to said housing and a free end said arched hook has a length that extends substantially at least 180 ° about said pivot point.

3. The injection port according to claim 1, further characterized in that said fixing mechanism comprises an arcuate hook that moves in pivot with respect to said housing, said hook has a fixed end attached to said housing and a free end said arcuate hook has a length that extends substantially more than 90 ° around said pivot point.

4. The injection port according to claim 1, further characterized in that said fixing mechanism comprises polyglactin.

5. The injection port according to claim 1, further characterized in that said fixing mechanism comprises polygallecapron.

6. The injection port according to claim 1, further characterized in that said fixing mechanism comprises iron.

7. The injection port according to claim 1, further characterized in that it includes a fixed catheter connection tube to said housing and in fluid communication with said reservoir.

8. The injection port according to claim 1, further characterized in that said housing comprises titanium.

9. The injection port according to claim 1, further characterized in that said septum is self-healing after being pierced by means of a needle and the needle is removed.

10. The injection port according to claim 1, further characterized in that said septum comprises silicone.

11. An implantable surgical injection port having an undeployed position, and a deployed position where it is fixed to the tissue, said port comprising: a) a housing having a closed distal end, an open proximal end and a reservoir fluid between them; b) a penetrable septum with a fixed needle to said housing around said opening; c) at least one fixing mechanism mounted to said housing for initially fixing said port to the tissue, said fixing mechanism comprises a bioabsorbable material and d) an adjustable gastric band fixed to said housing by means of a catheter connection tube that is fixed to said housing and in fluid communication with said reservoir.

12. The injection port according to claim 11, further characterized in that said fixing mechanism comprises an arcuate hook that moves in pivot with respect to said housing, said hook has a fixed end attached to said housing and a free end said arched hook has a length that extends substantially at least 180 ° about said pivot point.

13. The injection port according to claim 11, further characterized in that said fixing mechanism comprises an arcuate hook that moves in pivot with respect to said housing, said hook has a fixed end attached to said housing and a free end said arcuate hook has a length that extends substantially more than 90 ° around said pivot point.

14.- The injection port in accordance with the claim 11, further characterized in that said fixing mechanism comprises polyglactin.

15. - The injection port according to claim 11, further characterized in that said fixing mechanism comprises polyglecaprona.

16. The injection port according to claim 11, further characterized in that said fixing mechanism comprises polydioxanone.

17. The injection port according to claim 11, further characterized in that said fixing mechanism comprises iron.

18.- The injection port in accordance with the claim 11, further characterized in that said housing comprises titanium.

19. The injection port according to claim 11, further characterized in that said septum is self-healing after being punctured by means of a needle and the needle is removed.