SURGICAL PATCH AS WELL AS INTRODUCTION DEVICE

This invention relates to a medical apparatus and, more particularly, to the repair of hernias with a laparoscopic approach and associated plugs and patches.

A hernia is one of the most common ailments of mankind. Approximately five percent of the adult male population is affected. Basically, a hernia is a weakness or hole in the abdominal wall through which abdominal contents such as bowels may protrude. Inguinal or groin hernias normally occur at one or more of three locations. The first location is in the weakened wall or inguinal floor of the abdomen in Hesselbach's triangle. This type of hernia is called a direct hernia. An indirect hernia occurs at the internal ring adjacent to the vas deferens as it exits the abdomen to become part of the spermatic cord. The third is a femoral hernia that occurs adjacent and medial to the femoral blood vessels.

All hernias represent a potentially life threatening condition and once diagnosed they should be repaired unless there is some contraindication.

The surgical repair of an inguinal hernia (inguinal herniorrhaphy) is a common procedure which surgeons often perform on an outpatient basis. It is estimated that 500,000 are performed each year in the United States. According to the procedure, an anesthetic is first administered to the patient and the surgeon then makes a large incision, about 15,2 cm (6 inches), in the patient just above the inguinal ligament. Supporting abdominal muscle and fascia are dissected to reveal the hernia sac. The herniated contents protruding through the opening in the abdominal wall are returned to the abdomen. Thereafter, the surgeon closes the hernia sac. The local tissues are then sutured together from opposite sides of the weakened tissue, hole or hernia. The stretched or otherwise weakened tissue may be cut away. Where appropriate, a patch of artificial material may be sutured to the normal tissue to replace the stretched or otherwise weakened tissue or to reenforce over the outside of the repair. The incision is then closed over the repair. Recovery time necessary prior to heavy lifting or strenuous labor is usually six to eight weeks and recurrence rates may approach twenty percent.

Another more difficult approach which is less common, but more physiological, is to make an incision in the abdomen superior or cephalad to the hernia. The surgeon cuts through the abdominal wall to the last layer (the peritoneum). Dissection continues in this properitoneal approach and exposes the hernia defect from the inside. Again direct suture repair or patch repair may be performed. The recurrence rates are low with an inside patch repair because increased intra-abdominal pressure only serves to force the patch more firmly into place to plug the hole similar to a drain plug in a bathtub.

Although common, the standard operational procedures for repair of a hernia is undesirably lengthy and, consequently, costly, requires a large incision with the excessive dissection of normal tissue, causes excessive pain and discomfort to the patient, involves unacceptably long recovery and work disability time, and results in an unacceptably high recurrence rate.

Devices which are used in fields other than in the present invention are disclosed in WO 89/11301 and in US-A-3 857 395.

WO 89/11301 relates to a device for sealing percutaneous punctures or incisions within a vessel without resulting in any substantial reduction of blood flow through the vessel. This device comprises a tubular body having an outlet at its distal end, a closure member in form of a plug having a retraction filament connected thereto, and pusher means.

US-A-3 857 395 discloses a conformable absorbent tampon in combination with a device adapted to insert the tampon into the vaginal tract as well as to bilaterally spread the tampon open within the vaginal cavity after insertion at the option of the user. The described device comprises a fixed elongate outer element and a non tubular movable elongate inner element. The inner element may comprise a pair of slightly bent hinged legs which form a kind of diamond shaped structure.

Accordingly, it is an object of the present invention to provide an apparatus for the repair of hernias through laparoscopic techniques comprising a tubular sheath and a tubular plunger located within and moveable with respect to the sheath, the plunger having a distal end supporting a mending component adapted to be discharged from the sheath upon relative axial movement between the plunger and sheath, the plunger having an end extending proximally of the sheath for manipulation by a surgeon.

It is a further object of the present invention to minimize the time and cost of hernia operations.

It is a further object of the present invention to minimize a patient's pain and discomfort associated with a hernia operation.

It is a further object of the present invention to shorten the recovery time normally attendant with a hernia operation.

It is a further object of the present invention to reduce or preclude the recurrence of hernias.

Further objects of the present invention are to internally plug and or patch and restore stretched or weakened areas of an abdominal wall or overt hernia defects and to simultaneously patch all primary and secondary abdominal areas which are predisposed to hernias.

The foregoing has outlined some of the more pertinent objects of the present invention. These objects should be construed to be merely illustrative of some of the more prominent features and applications of the intended invention. Many other beneficial results can be attained by applying the disclosed invention in a different manner or by modifying the invention within the scope of the disclosure. Accordingly, other objects and a fuller understanding of the invention may be had by referring to the summary of the invention and the detailed description of the preferred embodiments in addition to the scope of the invention defined by the claims taken in conjunction with the accompanying drawings.

The invention is defined by the appended claims with specific embodiments shown on the attached drawings. For the purpose of summarizing the invention, the invention may be incorporated into an improved apparatus for the repair of hernias through laparoscopic techniques comprising a tubular sheath and a tubular plunger located within and moveable with respect to the sheath, the plunger having a distal end supporting a mending component adapted to be discharged from the sheath upon relative axial movement between the plunger and sheath, the plunger having an end extending proximally of the sheath for manipulation by a surgeon. The mending component is a patch.

The invention may also be incorporated into an apparatus for laparoscopically patching hernias comprising a tubular sheath; a tubular plunger located within and moveable with respect to the sheath, the proximal end of the plunger extending proximally outwardly of the sheath for manipulation by a surgeon; elongated means forming part of the plunger at the distal end thereof and forming a loop, the proximal end of the elongated means extending proximally outwardly of the sheath for manipulation by a surgeon; and a patch supported on the loop for movement therewith. The elongated means may be ribbon shaped and includes a worm gear for moving the elongated means with respect to the plunger and an enlargement at one end of the ribbon with a slot through which the elongated means passes to form the loop. The elongated means may be a thread including an eyelet formed in an intermediate portion of the thread through which the thread passes to form the loop. The loop may be formed of an absorbable material. The apparatus may further include means for securing the proximal end of the patch to the plunger. The apparatus further includes a guide rod as part of the plunger for guiding the movement of the ribbon with respect to the plunger during the blooming of the patch.

The invention may also be incorporated into a patch for positioning over the regions of a floor of an abdominal cavity normally susceptible to hernias, the patch having a proper anatomical and functional shape with a plurality of radially extending portions forming spaced recesses for the receipt of a vas deferens, testicular artery and vein and femoral vessels, the patch also having a passageway in a curved, symmetrical configuration for the receipt of a smoothly curved loop.

The invention may also be incorporated into a system for the repair of hernias through laparoscopic techniques including plugging and patching, the system comprising a first assembly having a tubular sheath; a tubular plunger located within and moveable with respect to the sheath, the plunger having a distal end spaced proximally of the distal end of the sheath and a proximal end extending proximally of the proximal end of the sheath; a plug within the sheath at the distal end and moveable from interior thereof to exterior thereof upon manipulation of the proximal ends of the sheath and plunger by a surgeon; and the system further including a second assembly having another tubular sheath; another tubular plunger located within and moveable with respect to the other sheath, the proximal end of the other plunger extending proximally outwardly of the other sheath for manipulation by a surgeon; elongated means extending through the other plunger and, at the distal end thereof forming a loop, the proximal end of the elongated means extending proximally outwardly of the other sheath for manipulation by a surgeon; and a patch supported on the loop for movement therewith.

The foregoing has outlined rather broadly the more pertinent and important features of the present invention in order that the detailed description of the invention that follows may be better understood so that the present contribution to the art can be more fully appreciated. Additional features of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and the disclosed specific embodiments may be readily utilized as a basis for modifying or designing other methods and apparatus for carrying out the same purposes of the present invention.

For a fuller understanding of the nature and objects of the invention, reference should be had to the following detailed description taken in conjunction with the accompanying drawings in which:

1. Figure 1 shows a portion of the abdominal wall from the inside where hernias normally occur and also illustrating therein a patch for their repair and the precluding of further hernias.
2. Figure 2 is a perspective view of the patch constructed in accordance with the principles of the present invention and as shown in Figure 1, shown in association with the patch is an introducer functioning as a delivery assembly for the patch.
3. Figure 3 is a sectional view of a portion of the patch shown in Figure 2.
4. Figure 4 is a perspective view of a patch similar to that of Figure 2, but in mirror image for use on the other side of the patient and illustrating a smaller design as for a child.
5. Figure 5 is a perspective illustration of a portion of the introducer including an exterior sheath and plunger/expander assembly.
6. Figure 6 is a perspective illustration of the patch of Figure 4 with the patch introducer of Figure 5 and with parts broken away to show certain internal constructions thereof.
7. Figure 7 is an elevational view, partly in section, of the introducer of Figures 2 through 6 but with the patch prior to discharge.
8. Figures 8 through 10 are sectional views of the introducer of Figure 7 taken along lines 8-8, 9-9 and 10-10 of Figure 7.
9. Figures 11 through 13 are elevational views, partly in section, of an alternate embodiment of an introducer for the patch.
10. Figure 14 is a perspective illustration of a patch delivery assembly constructed in accordance with a further alternate embodiment of the invention.
11. Figures 15 and 16 illustrate a plug usable in association with the apparatus shown in Figures 1 through 14.
12. Figures 17 through 19 are elevational views, partly in section, of an introducer for the plug constructed in accordance with yet a further embodiment of the invention.

Similar reference numerals refer to similar parts throughout the various Figures.

Shown in Figure 1 is that portion of the abdomen where hernias normally occur. Whether through old age, accident, personal abuse, congenital problems, or the like, the inguinal floor of the abdomen known as Hesselbach's triangle may become weakened to the point whereby inner abdominal contents such as a bowel may protrude. When the organ extending therethrough is a portion of the bowel, serious illness or even death may occur. This is a direct inguinal hernia. There are two other common types of groin hernias. These occur adjacent to either the vas deferens (indirect) or the femoral vessels (femoral hernia). When either the internal inguinal ring through which the vas deferens passes or the abdominal wall adjacent to the femoral vessels becomes enlarged, an opening is created through which abdominal contents such as intestines may protrude thereby constituting a hernia. In the past, surgeons operated upon the hernia area either from above (properitoneal) or below (anterior) with large incisions which lead to great disability.

The present invention includes introducers 10 with plugs 12 and patches 14, with the patches designed to cover all three areas where groin hernias normally occur and accomplishes a more physiological repair with a smaller incision utilizing laparoscopic technique by use of a specifically designed introducer and patch and properitoneal approach presently not used.

The patch 14 is preferably fabricated of a mono-filament thread which is woven, knitted or otherwise formed into a fabric which is then cut to a shape. It has a main central portion 16 to cover the inguinal floor area where direct groin hernias normally occur. The shape is generally in the shape of a trapezoid with a major axis and a minor axis.

Extending outwardly from one edge are three asymmetrical portions, formed as three fingers 18, 20 and 22 with the central finger being smaller than the other two. Formed between the fingers are spaced concave recesses 24 and 26, sized and positioned to be placed in close proximity to the vas deferens and or the femoral vessels. Those portions of the patch located adjacent to the recesses are thus adapted to cover those areas of the abdomen where indirect and femoral hernias normally occur. At the same time, the central portion of the patch is adapted to cover the area of the inguinal floor where direct hernias normally occur.

The threads from which the patch is fabricated are of a surgically clean material which is durable, flexible, essentially inextensible and resistant to corrosion from bodily fluids. By way of example, one acceptable material is polypropylene such as Marlex ® mesh. Marlex is a trademark of the Johnson & Johnson Company of Somerville NJ. Further, by way of example, one acceptable material thread is Nylon ® polymer. Nylon is a registered trademark of the E.I. DuPont deNemours Company of Wilmington, Delaware.

Formed into the patch is a passageway 30 for receiving a loop 32, the loop constituting the distal part of the patch delivery assembly or introducer 10. The passageway is shown in the preferred embodiment as spaced axial slits 34 through which the loop is threaded. The passageway may take other forms such as an elongated extent of fabric, preferably of the same material as the patch, secured in a symmetrical manner interior of the periphery of the patch.

When distended, the loop 32 is in the form of an ellipse which has a major axis and a minor axis coextensive with the major axis and minor axis of the patch. In the alternative, the loop and its passageway may take one of many other forms such as that of a teardrop, circle or oval as shown in Figures 1, 2, 4, 5, 6, 12, 13 and 14. Other smoothly shaped, curved configurations could be utilized. The periphery of the patch is at varying distances from the passageway and loop. Hence the peripheral portions of the patch do not immediately reach all the areas of direct as well as indirect hernias. Consequently, conventional laparoscopic techniques must be employed by the surgeon to provide final positioning of the patch after initial placement by the loop.

Located within the passageway is the loop 32 of the ribbon 36, constructed of surgically antiseptic material and shaped in a smoothly curved configuration such as an ellipse when expanded. The loop 32 is of a size and configuration to be received within the passageway of the patch 14. The loop is at the far or distal end of the plunger 42. As shown in Figure 2, the loop of the ribbon holds the majority of the patch in an extended orientation for initial placement on the abdominal wall over the hernia to be repaired. The proximal end of the loop is a ribbon extension of the loop which, like the loop, is flexible, but sufficiently rigid to function in association with the plunger 42 so that a surgeon may remotely push, pull, or rotate the loop and, consequently, the patch, during an operation. The plunger 42 includes a cylinder 44 and guide beam 46. The introducer 10 includes the plunger 42 and sheath 48.

The patch 14 as well as its supporting ribbon loop 32 and its proximal extensions 52 are preferably prepackaged in a delivery assembly, the introducer 10, prior to use by insertion through a sleeve which is conventionally placed in a patient by a trochar.

The delivery assembly 10 is best seen in Figure 7. Its major components include an external cylindrical sheath 48 and an internal plunger 42. The proximal end of the plunger includes a set screw 53 oriented to releasably secure one end of the ribbon. The proximal end of the plunger/expander assembly 42 includes a worm gear 54 for coupling with teeth formed on the ribbon. Note Figure 8. The worm gear 54 is a preferred mechanism since it permits precise adjustments in the moving of the loop and patch. In this manner, the surgeon may effect the precise movement of the loop in either direction but prevents the inadvertent movement thereof. A cylindrical guide beam 46 with flat faces is located interiorly along the length of the introducer 10 to act as a bearing surface during operation of the set screw 53 and worm gear 54 and for guiding the movement of the ribbon 36 with respect to the plunger 42 during the blooming of the patch. A weld 56, a dot of glue, or the like couples the proximal end of the patch to the distal end of the pusher rod.

In operation and use, the introducer 10 is inserted through the sleeve with its distal end adjacent to the area of the abdominal wall to be patched. The plunger/expander 42 and patch 14 are pre-positioned within the sheath 48 as shown in Figure 7. The introducer 10 then is moved forward by the surgeon moving the introducer with respect to the sleeve or withdrawing the sleeve with respect to the introducer. The ribbon, loop and patch move with the introducer when relative movement occurs between the sleeve and introducer. The plunger is depressed to dispense the main body of the patch. Thereafter, the surgeon rotates the knob 58 of the worm gear to enlarge the loop and cause the patch to bloom into the anatomically desired orientation as shown in Figures 1, 2 and 13. Using a second laproscopic opening, the surgeon will position the edges of the patch into final position. The patch will remain in position due to the pressure applied to it by the normal abdominal contents. Staples or sutures could be employed to further secure the patch in its final position.

The Figure 11 through 13 embodiment illustrates an alternate introducer 60 for holding the patch and for pushing it outwardly from the distal end of the sleeve. In this embodiment, the ribbon 62 is formed with an enlargement or block 64 at its distal end. The block has a slot 66 through which the ribbon passes to form a loop 68, in a manner similar to a lasso, which supports a patch 70 as in the prior embodiment. The slot is preferably formed with a ratchet tooth to sequentially engage ratchet teeth on the ribbon to allow for only one way movement of the ribbon during blooming of the patch.

The proximal end of the block is not coupled to the distal end of the plunger. Further, the proximal end of the patch is coupled to the distal end of the block as by a weld 74 to hold the proximal end of the patch in position as the distal end of the ribbon is moved distally to effect the blooming of the patch. The guide beam 76 has one flat side to receive and guide the ribbon 62 for movement with respect to the plunger cylinder 78 during the blooming of the patch 70.

In this embodiment, the distal end of the sheath 88 has axially slits 82 at a plurality of locations with the end forming a slight taper or bend. In this manner, the plunger 86 may be moved with respect to the sheath 88, from the Figure 11 position to the Figure 12 position. The surgeon can feel the slight resistance caused by the block 64 against the bend indicating that the Figure 12 position has been reached. Thereafter, the proximal end of the ribbon may be fed distally with respect to the plunger and block to effect the blooming of the patch. Thereafter, the block is moved distally a greater distance until the Figure 13 position is reached and the resistance to movement is no longer felt by the surgeon, thus freeing the patch from the introducer. The patch 70, loop 68 and block 64 are then cut free of the plunger 86 and the remainder of the ribbon.

In yet a further embodiment of the introducer 90, that shown in Figure 14, the ribbon 92 is replaced by a looped mono-filament thread. The mono-filament thread is preferably of a surgically antiseptic, durable, inextensible material. By way of example, acceptable materials are Nylon®, polypropylene and polyglycolic acid including PDS. PDS is a tradename of the Johnson and Johnson Company of Sommerville, NJ. These typical materials will allow the threads to be pushed from the introducer by the surgeon. The thread is shaped with a loop 94 received at its distal end. The proximal ends of the thread are for pushing and pulling the thread, and consequently blooming the patch, with respect to the plunger and sheath.

An intermediate portion of the thread is formed with an eyelet 96 adjacent to the proximal end of the plunger for the sliding passage of the proximal end of the thread. As in the embodiment discussed immediately hereinabove, the loop supporting the patch is formed as a lasso. The two proximal ends of the thread are manipulated by a surgeon during operation and use. A guide beam 98 shaped as an I-beam is incorporated within the plunger to guide the movement of the thread ends with respect to the plunger during the blooming of the patch. There is no need for a direct attachment of the loop to the plunger as this occurs passively. There is, however, a need for coupling the patch to the eyelet for proper patch placement. With the thread and patch dispensed outside the sheath as described above, the proximal end of the thread end passing through the eyelet is pushed so that a central extent of the thread begins to move forward out of the sheath to effect the blooming of the patch.

In all of the embodiments requiring thread removal, after final positioning of the patch, the proximal end of the patch must be cut from the its attachment from the introducer, block or eyelet ribbon while the distal end of the loop must be cut so that the introducer and ribbon may be withdrawn from the patch and site of the operation.

In the embodiments of Figures 4 and 11 through 13, when the loop is formed of an absorbable material, the loop must be cut free of the remainder of the ribbon.

It should be understood that a wide variety of mechanisms could be used to support the patch and to effect its blooming and positioning. In the disclosed embodiments herein, the mono-filament thread could be replaced by a ribbon and the ribbon could be replaced by a mono-filament thread. Further, a wide variety of materials could be substituted between the thread embodiment and ribbon embodiments including the use of absorbable, biodegradable or biocompatible materials for the loop that need not be removed. One typical material is polyglycolic acid.

Note is taken that the Figure 14 embodiment illustrates the introducer 90 with a slight curve. This slight curve allows the surgeon to more readily axially rotate the introducer and thus the patch, for a more precise patch positioning. Such curve may also be utilized in the plug introducer assembly discussed hereinafter. Conventional straight or flexible sleeves may, of course, also be employed.

One distinguishing characteristic of the present invention is the shaping of the distal end of the introducer with a bevel 102. This will allow the surgeon to view the orientation if the introducer and patch on a monitor or through an operating laparoscope prior to moving the patch from the interior of the introducer. In addition, radiopaque markers 104 on the patch and/or plug could be utilized for determining their orientation and location by conventional radiographic techniques.

Plugs are shown in Figures 15 and 16 while their introducer 110 is shown in Figures 17 through 19. The Figure 15 plug 12 is simply a patch of surgical fabric or mesh such as Marlex ® mesh. The material is spirally wrapped to form a mending component in a generally cylindrical shape. The term generally cylindrical shape is intended to include components which have a taper, as for example a truncated cone. It may also be fabricated as a one piece molded object.

The Figure 16 plug 112 is similar in construction to the Figure 15 plug 12. It includes, in addition, a flange 114. The flange is fabricated of a material similar to the patch. The flange may be with or without one peripheral edge that includes a radial extension with two symmetric fingers 118 and 120 and a recess 122 for receiving an adjacent vas deferens or femoral blood vessels. The central plug component may be of an absorbable or biodegradable material to be assimilated into bodily tissue over time. The plug is also preferably formed with openings or interstices to accelerate the healing of the opening being patched through the promoting of scar tissue in growth. The plug may be made of a material such that it expands and swells if exposed to fluids. A sponge is typical of such a material.

The plug introducer assembly 110 is seen in Figures 17, 18 and 19. During operation and use, the assembly is positioned through a sleeve. The assembly includes an exterior cylindrical sheath 128 and an interior cylindrical plunger 126. As seen in Figure 17, the plug is initially located in the distal end of the sheath with the flange, if utilized, at the proximal end of the plug. The plunger is proximally located with respect to the plug.

In operation and use, the distal end of the introducer and plug is simply inserted into the hernia defect 132 and dispensed by depressing the plunger. This withdraws the sheath leaving the plug in place. Additional plugs may be placed to fill the defect if excessively large. Alternatively the plug with flange may be inserted to plug the defect and support the adjacent weak tissue. The dispensing of the plug may be effected by any relative movement between the plunger and sheath, by moving the plunger with respect to the sheath or the sheath with respect to the plunger. Figure 18 illustrates the plug in the tissue opening after being dispensed. Figure 19 illustrates the plug without a flange. Handles at the proximal ends of the sheath and plunger assist the surgeon in this procedure. Once placed within the tissue to be repaired, the plug or plugs may be caused to swell to a larger diameter through being irrigated either naturally through bodily fluids or artificially as through a saline solution introduced by the surgeon.

The plug and patch and their delivery apparatus may be utilized independently of each other or sequentially in system configuration, depending on the condition of the patient and the parts of the body to be repaired. The utilized mending component, whether plug or patch, are at the discretion of the surgeon.

During an operation, the operating laparoscope, sleeve with its contents, is positioned within the incision into the properitoneal space. The space is dissected with insufflation of carbon dioxide or other conventional gas technique. The laparoscope and its contents are manipulated inwardly and outwardly thereof for effecting the appropriate procedures. After dissection of the space other punctures in the abdomen are made for placement of a second or third sleeve. These additional sleeves allow use of additional instruments for manipulation, dissection, and use of a laser or cautery. Similarly, the patch and/or plug introducers and contents are manipulated inwardly and outwardly of the sleeves.

To position the plug in its orientation adjacent to the intended area, the plug is positioned within the distal end of the introducer. The plug is initially packaged within the introducer. The introducer and its contents are advanced to within the hernial defect which is to receive the plug. The surgeon pushes the proximal end of the plunger forward while the sheath is held against movement. The plug will then move outside of the sheath into the position of Figure 18. The sheath is then withdrawn while holding the plug against movement while allowing complete release from the sheath. Additional plugs may be inserted as needed.

To position the patch in its orientation adjacent to the intended area, the patch is positioned on the loop and located within the distal end of the introducer. The patch and loop are initially packaged within the introducer. The introducer and its contents are advanced to a position adjacent to the area of the abdominal wall which is to receive the patch. The patch is dispensed by the surgeon pushing the proximal end of the plunger forward while the sheath is held against movement. The patch will then move outside of the introducer with the loop resiling to the elliptical shape of Figures 1 and 2. The blooming of the patch is effected by the extending of the loop within the patch thus distending the patch to proper, anatomically correct shape. This procedure may be observed by the surgeon through conventional laparoscopic techniques.

With the central portion of the patch properly positioned, the surgeon may manipulate the edges of the patch exterior of the loop, and secure the patch in proper position. Staples or sutures could be utilized but the contents of the abdominal cavity may be sufficient to apply adequate pressure to hold the patches in proper position.

With the patch having been secured around its periphery as shown in Figure 1, the ribbon may be removed from the patch prior to the withdrawal of the introducer. Once again, conventional laparoscopic techniques may be employed to cut the ribbon at its distal end so that the ribbon may be slid from the passageway and withdrawn prior to removal of the introducer. This step is eliminated if the loop is of a degradable material. The patch and loop must then be cut away from the plunger prior to removal of the introducer.

The present invention may be utilized by a surgeon in carrying out a new laparoscopic procedure for repairing hernias.