Onlay Access Port

Inventor: Sidney P. Rohrscheib, M. D.

Technical Field

Implantable subcutaneous injection ports have been used primarily for the purpose of vascular access. The devices are generally implanted beneath the skin of a patient near the upper chest. The injection port exhibits a silicon membrane overlying a chamber which is, in turn, connected to tubing and catheter usually entering the internal jugular or subclavian vein. The chamber is accessed by puncturing the overlying skin with a Huber point needle, then puncturing the self sealing silicon membrane of the port. This allows the repeated injection of medicines or the drawing of blood with low risk of infection at the same time preserving the integrity of the skin. Various injection ports are commercially available. By way of example is the injection port available under the brand name of Port-A-Cath® Implantable Venous Access Systems.

Disclosure of the Invention

The onlay access port exhibited here represents an advance in the design of subcutaneous medical access devices. This is especially true for applications where the access port is placed on the abdominal fascia, and where the tubing egress route is through the abdominal musculature and into the peritoneal cavity. Such an application is laparoscopic adjustable gastric banding. Ports currently used in laparoscopic adjustable gastric banding borrow their design from those traditionally used as venous access devices placed on the chest wall. Traditional venous access ports exhibit tubing exiting from the side of the port which is advantageous in these applications where a length of tubing will initially track more or less horizontally, parallel to the chest wall then entering a large vein. Venous access applications present minimal opportunity for the tubing to be routed at sharp angles and consequently less opportunity for kinking and resulting obstruction. Use of venous access ports in procedures such as laparoscopic adjustable gastric banding where it requires the routing of tubing through the abdominal fascia and into the peritoneal cavity instead of routing the tubing horizontally along the chest wall. This often requires the tubing to be routed at sharper angles. This results in the most common complications in laparoscopic adjustable gastric banding which are the occlusion of tubing due to kinking and the loss of integrity of the tubing wall by cracking due to angulation stresses. The onlay port described here shows an exit directly beneath and at the bottom of the onlay access port allowing direct vertical penetration of the abdominal fascia by the tubing which exits the port at right angles to the horizontal orientation of the onlay port.

This new design also reduces the possibility of puncturing the tubing during needle access to the port and reduces the possibility of port to become malpositioned or rotated due to the horizontal fixed tubing which eliminates all but one axis of freedom about which it can rotate. Additionally the onlay access port will be easier to place at surgery. Direct placement over a trochar site allow the tubing to be inserted through a smaller incision immediately below the only access port. This further enhances the stability of the port installation and reduces the need for fixation to the muscular fascia by suturing or other fixative technique. The only access port will be manufactured of titanium and silicone or other suitable materials that are inert and well tolerated by the body

Alternative embodiments of the port utilizing u-joint and ball joint connectors, will add additional flexibility in the catheter attachment allowing the patent greater freedom of movement with lessened risk of dislodging the access port.

Brief Description of the Drawings

Figure 1 is a cross section view of the onlay access port.

Figure 2 is a perspective view of the onlay access port components.

Figure 3 is a perspective view of the onlay port bottom.

Figure 4 is a perspective view of the only port embodiment showing joined halves of the injection chamber housing.

Figure 5 is a perspective view of the injection chamber housing halves disengaged.

Figure 6 is a map view of the injection chamber housing halves disengaged.

Figure 7 is a cross section view of the onlay port show an angular catheter.

Figure 8 is a cross section view of the onlay port with an angular catheter seat. Figure 9 is a cross section view showing the modified injection chamber housing bottom aperture.

Figure 10 is a map view of first shield, second shield and second shield aperture.

Figure 11 is a cross section view an alternative configuration of the shield, second shield and second shield aperture.

Figure 12 is a cross section view of the u-joint.

Figure 13 is a cross section view of the ball joint.

Figure 14 is a cross section view of the ball joint with o-ring retainer is place.

Component List Self-sealing septum

Septum seat 2

Septum seat 2A

Injection chamber sidewall 3

Injection chamber bottom 4

Fluid path 5

First chamber aperture 5A

First housing aperture 5B

Catheter seat 6

First catheter seat end 7

Second catheter seat end 7A

Barbs 7C

Sidewall lip 8

Injection chamber sidewall 9

Injection chamber housing bottom 10

Injection chamber housing bottom aperture 1OA

Shoe 11

Parabolic lip HA

Injection chamber 12

Catheter 13

Catheter end 13A Catheter end 13B

Catheter wall 13D

Catheter fluid path 13C

Injection chamber housing 14

Barbs 15

First barb end 15A

Second barb end 15B

Secondary barbs 15C

Chamber housing first half 16

Chamber housing second half 17

Second joining insert 18

Expanded lip 18A

Joining pocket 19

Narrowed Hp retainer 19A

Second joining pocket 20

Joining surfaces 2OA

Joining insert 21

Angular catheter 22

Bottom aperture 25

First shield 26

Bearing support 28

Bearings 29

First shield aperture 30

Second shield 32

Second shield aperture 32A

Bearing support aperture 34

U-ioint 35

Upper u-joint component 35A

Lower u-ioint component 36

Fluidly sealed hinge 36A

Ball housing 37 First ball housing end 37A

Second ball housine end 37B

Ball housing threads 38

Ball component 39

Channel 40

Ball ioint assembly 4OA

Catheter seat 41

Ball catheter seat first end 41A

Ball catheter seat second end 41B

Ball catheter channel 41C

First o-ring 43A

O-ring retainer 44

First ball housing end aperture 46

Second ball housing aperture 48

Best Mode of Carrying Out the Invention

Figure 1 shows the three major components of the access port, which are the injection chamber housing 14 with injection chamber 12 disposed within. Also partially disposed within the injection chamber housing is catheter 13. Catheter 13 exhibits a first catheter end 13A and a second catheter end 13B. Catheter 13 also exhibits a catheter fluid path 13C. Second catheter end 13B is disposed over catheter seat 6. Catheter seat 6 exhibits a first catheter seat end 7 and a second catheter seat end 7A. First catheter seat end 7 exhibits barbs 7C. Second catheter seat end 7A is attached to injection chamber bottom 4. Fluid path 5 extends through the center of catheter seat 6 and fluidly communicates with the injection chamber through first chamber aperture 5 A in injection chamber bottom 4. Catheter 13 is disposed over catheter seat 6. The fluid path 5 of catheter seat 6 is fluidly communicates with the catheter fluid path 13C of catheter 13. Injection chamber housing 14 is annular in shape and is composed of injection chamber sidewall 9, injection chamber housing bottom 10, and sidewall lip 8. Injection chamber housing 14 exhibits first housing aperture 5B which penetrates injection chamber housing bottom 10 through first housing aperture 5B. First housing aperture 5B exhibits shoe 11. Shoe 11 exhibits a parabolic lip HA. The parabolic lip HA will of course be annular in shape following the path of the first housing aperture 5B of injection chamber housing bottom 10. The parabolic Hp HA of shoe 11 applies pressure to Catheter wall 13D which are compressed between parabolic lip HA and catheter seat 6. The compression thus allows catheter 13 to fluidly seal against catheter seat 6 and further to be retained upon catheter seat 6 and within injection chamber housing 14. Injection chamber sidewall 3 exhibits septum seat 2 and septum seat 2A. Self-sealing septum 1 is mounted within the injection chamber and sealed against the injection chamber sidewalls 3 by the septum seat 2 and septum seat 2A. Septum seat 2 and septum seat 2A may retain self- sealing septum 1 by crimping or providing a stable seat for fixing the self-sealing septum with adhesive.

Figure 2 shows the three major components of the onlay access port disassembled but in a configuration prior to the assembly of the port. This figure shows injection chamber 12 above catheter 13 which is passed through first housing aperture 5B of the injection chamber housing bottom 10. This exhibits one of the several advantages of this improved port design. A number of circumstances can be envisioned in which it would be advantageous to have the capacity to assemble or disassemble the port. These situations might include a desire to reposition the port, or a need to repair the tubing proximate to the base of the port.

Turn now to Figure 3, an alternative embodiment of the onlay port is seen where injection housing bottom 10 exhibits a plurality of barbs 15. Catheter 13 is designed to be inserted through a trochar site in the fascia. Injection chamber housing bottom 10 then rests on the fascia. In order to secure the onlay port to the fascia, the barbs having a first barb end 15A and a second barb end 15B then rests on the fascia. First barb end 15A is attached to injection chamber housing bottom 10. Second barb end 15B is free floating. When the injection chamber housing 14 is rotated, the second barb end 15B then penetrates the fascia. The second barb end 15B may also exhibit secondary barbs 15C allowing the barbs to be held within the fascia.

Another embodiment of the onlay port is exhibited in Figure 4, where injection chamber housing 14 is shown having chamber housing first half 16 and chamber housing second half 17. The chamber housing halves are shown assembled in Figure 4. Figure 5 shows the chamber housing halves separated. Figure 6 shows chamber housing first half 16 exhibiting joining pocket 19 and joining insert 21. Chamber housing second half 17 exhibits second joining insert 18 and second joining pocket 20. When chamber housing first half 16 is joined to chamber housing second half 17, second joining insert 18 is disposed within joining pocket 19 and joining insert 21 is disposed within second joining pocket 20. A plurality of joining inserts and corresponding joining pockets may be exhibited up and down the joining surfaces 2OA of chamber housing first half 16 and chamber housing second half 17.

The joining pockets and the joining inserts may be configured in such a way that when joining insert is disposed within the joining pocket, it is retained therein by means of an expanded lip 18A on second joining insert 18 which is retained by a narrowed Hp retainer 19A in joining pocket 19. Alternatively joining pockets and joining inserts could be smooth- walled and would be joined by an appropriate adhesive.

As mentioned earlier, the appropriate routing of catheter 13 is to avoid kinking which is a significant complication in the use of these devices in laproscopic adjustable gastric banding. Figure 7 exhibits angular catheter 22 where in the catheter is molded in an angular configuration. If the surgeon determines a particular orientation of the catheter is appropriate, the angular catheter 22 can then be oriented in the appropriate direction either after or prior to onlay port component assembly.

Figure 8 exhibits yet another embodiment of the onlay port. First chamber aperture 5 A appears where injection chamber sidewall 3 meets injection chamber bottom 4. This places the first chamber aperture 5A well away from an injection needle. The catheter seat 6 then extends from injection chamber bottom 4 at an angle thus creating the necessary angular routing should the surgeon determine such an angular routing is desirable.

Figure 9 shows an alternative embodiment of the onlay port wherein the catheter seat 6 is removed from injection chamber 14 allowing injection chamber bottom 4 to exhibit a centrally located bottom aperture 25. Immediately under the centrally located bottom aperture 25 is first shield 26. First shield 26 is fixed to the internal portion of the injection chamber housing bottom 10 and extends across injection chamber housing bottom aperture 1OA. This is designed to prevent the needle from penetrating the self- sealing septum septum 1 and continuing on to penetrate and to potentially compromise the integrity of a catheter. However first shield aperture 30 allows fluids to pass through and around second aperture shield 26. First housing aperture 1OA is also modified by the addition of bearing support 28. Bearing support 28 is annular in nature extending around the circumference of first housing aperture 1OA and exhibits bearing support aperture 34. Extending through baring support aperture 34 are bearings 29.

Injection chamber bottom aperture 25 need not be centrally located but may be located in any position such that fluid may pass from the injection chamber 12. It should also be noted that the first shield aperture 30 need not be confined to any particular location on first shield 26. Figure 10 shows an alternate location for first shield aperture 30. Second shield 32 may then be significantly reduced in size and need cover only the first shield aperture 30 as can be seen in Figure 1 1 where second shield aperture 32A is greatly reduced in size.

Figure 12 shows u-joint 35 inserted through bearings 29. U-joint 35 exhibits an upper u-joint component 35A and a lower u-joint component 36. Upper u-joint component 35A may rotate 360 degrees upon bearings 29. Lower u-joint component 36 is attached through a fluidly sealed hinge 36A to upper u-joint component 35A. Lower u- joint component 36 may swing through an arc of 180 degrees. This, in combination with the ability for upper u-joint component 35 to rotate within bearings 29, allows positioning catheter 13 and any conceivable angle.

Figure 13 shows ball joint assembly 4OA disposed within bearing support aperture 34. Ball joint assembly 4OA is composed of ball housing 37 which exhibits internal annular o-ring seat 43. Disposed within o-ring seat 43 is o-ring 43A. Ball housing 37 exhibits first ball housing end 37A and second ball housing end 37B. Second ball housing end 37B is mounted to bearing support 28 and fluidly communicates with bearing support aperture 34. First ball housing end 37A is rolled inward such that first ball housing end aperture 46 is smaller in diameter than the second ball housing aperture 48. Ball component 39 is composed of a sphere of a diameter allowing the ball component 39 to be disposed within ball housing 37 but of such a diameter that first ball housing end aperture 46 retains the ball component 39 within ball housing 37. Ball component 39 exhibits channel 40 allowing fluid flow through. Ball component 39 is attached to ball catheter seat 41 which exhibits ball catheter seat first end 41A, ball catheter seat second end 41B and ball catheter channel 41C. Ball catheter seat second end 41B ball component 39 and ball catheter channel 41C fluidly communicates with channel 40. When ball component 39 is in place at first ball housing end 37A, it rotates against first o-ring 43A providing a fluid tight seal. Ball component 39 may rotate within ball housing again allowing a significant range of angles that catheter 13 may adopt.

Figure 14 shows ball housing 37 with the addition of o-ring retainer 44 . O-ring retainer 44 exhibits retainer threads 48 on its outer portions. It can therefore be disposed within the ball housing threads 38. O-ring retainer 44 then depresses second o-ring 46 against top of ball component 39 maintaining a fluid tight seal.

Industrial Applicability

The invention is applicable to laparoscopic adjustable gastric banding surgery or any surgical procedure where the implantation of an access port with the characteristics of the above described invention would be desirable.