Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-03-28
2002-08-13
Bockelman, Mark (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S097010, C604S097020, C604S099020
Reexamination Certificate
active
06432081
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to the treatment of volume deficiency disorders and syndromes, and more particularly to devices that deliver fluid at a controlled pressure into an interstice of a patient to effect tissue expansion and growth of the surrounding tissue, and to surgical procedures for augmenting volumetrically deficient natural body structures or for reconstructing damaged natural body tissue by attachment of tissue segments cultivated by tissue expansion. Methods of delivering fluid at a controlled pressure into an interstice are also disclosed.
Biological volume deficiencies, such as short gut syndrome, are persistent conditions that result when the volumetric capacity of a natural body structure, such as a bladder or a lung, is insufficient to allow the organ to operate effectively or at all. Additionally, the lack of volumetric capacity can create internal fluid pressures or body fluid reflux that damages other organs and tissue. Among the many causes of such deficiencies are birth defects and abdominal trauma.
Presently, the afflicted population receives surgical treatment, typically in the form of augmentation procedures that increase volumetric capacity of the body structure by rebuilding the structure in a procedure that attaches a flap of additional tissue to the afflicted structure. For example, an infant born with insufficient bladder capacity can receive a bladder augmentation in a procedure that typically rebuilds the infant's bladder by attaching a flap of gastrointestinal tissue to the bladder wall. The surgeon attaches the gastrointestinal tissue to the bladder wall in a manner that increases the surface area of the surrounding wall and thereby increase the volumetric capacity of the bladder. Generally, the surgeon selects gastrointestinal tissue because this tissue normally is available in sufficient amounts within the patient to provide the needed tissue for the augmentation procedure.
Although these procedures can be successful at relieving volumetric capacity deficiency, the complications that arise from attaching different tissue types can be severe and persistent. For example, with respect to bladder augmentation by attachment of gastrointestinal tract, the resulting complications for any patient can include lithiasis, metabolic complications, increased mucous production, increased infections, perforations and even malignant growths within the treated body structure. It is generally understood by the medical community that these complications can arise due to the attachment of a tissue type that lacks sufficient compatibility with the natural tissue of the body structure. Furthermore, bladder augmentation requires invasive surgical procedures which can cause patient discomfort and may require extended times for recovery.
SUMMARY OF THE INVENTION
The present invention provides systems and methods for promoting the growth or expansion of biological tissue, thereby increasing the volumetric capacity of a natural body structure. Tissue portions (e.g., which have been surgically resected from the expanded body structure) can also be used in reconstructive surgery. In particular, the present invention provides methods for promoting progressive tissue growth for bladder expansion. To this end, the present invention discloses systems and methods that introduce a pressurized fluid within a body structure, such as a urinary bladder, of a patient. The pressurized fluid causes the surrounding tissue to expand and thereby creates a condition that is generally understood to promote tissue growth. The expansion of the body structure can substantially relieve the condition of volume deficiency.
As used herein, the term “tissue expansion” is intended to encompass dilation of natural body lumens, stretching of tissue segments and promotion of new tissue growth in response to an applied pressure. The term “volume deficiency” is intended to encompass disorder and syndromes related to deficient volumetric capacity of a space or gap between tissue or within a natural body structure and includes by way of example, short gut syndrome and bladder volume insufficiency.
“Interstitial cavity,” as the term is used herein, encompasses interstices in a tissue or structure of a natural body structure, spaces and gaps existing between layers of tissue or existing within organs, and can include interstices within the interior of the ureter, bladder, intestines, stomach, esophagus, trachea, lung, blood vessel or other organ or body cavity, and will be further understood to include any surgically created interstice that defines an interior cavity surrounded by tissue.
The term “injection port,” as used herein, refers to an element adapted for introduction of a fluid under pressure. Preferably, an injection port is adapted for pressure-tight connection to a catheter and provides a pressure-tight connection to a source of fluid under pressure. Injection ports suitable for use in the systems and methods of the invention are known in the art and include, but are not limited to, septa (which can be self-sealing), adapters such as threaded nipples or Luer-type adapters, and the like.
In one aspect, the present invention encompasses devices for delivering fluids under pressure to an interstitial cavity (e.g., the urinary bladder) within a patient. Generally, the devices include an inflatable balloon, a catheter element that couples a source of fluid under pressure into fluid communication with the inflatable balloon, and a valve element that is adapted to restrict the flow of the fluid to a select direction of flow and thereby prevent back flow of fluid. The balloon is preferably dimensioned for placement within an interstitial cavity, e.g., the balloon is selected such that the balloon will exert pressure on a tissue wall such that tissue expansion is promoted. The catheter element includes a first lumen for flowing the fluid under pressure into the balloon. The catheter preferably includes at least one drain opening at or near a distal end of the catheter, drainage means (e.g., a body fluid collection element such as a drainage bag) secured to a proximal end of the catheter, and a second catheter lumen in fluid communication with the drain opening and the drainage means, for drainage of a body fluid from the body cavity to the drainage means. Although in a preferred embodiment a single catheter is preferred (which catheter can include a plurality of lumens), it will be understood that the invention also contemplates the use of a plurality of catheter elements (e.g., each catheter having a single lumen) for providing a fluid under pressure and providing a drainage path for a body fluid.
In a preferred embodiment of the invention, the fluid delivering devices further include a pressure release element that reduces fluid pressure within the interstitial cavity by releasing fluid responsive to a user-selected fluid pressure limit. One realization of the pressure release element can be as a release port element that is arranged in fluid communication with the first lumen of the catheter element, and therefore, the fluid within the first catheter lumen, and that further includes a release plug that fluidicly seals the release port to maintain fluid in the first catheter lumen as long as the fluid pressure is below a predefined threshold pressure, and that is adapted to disengage from the release port responsive to the fluid in the first catheter lumen, or in the balloon or interstitial cavity, reaching the threshold fluid pressure limit.
In a particularly preferred embodiment, the fluid delivering devices of the invention can be configured for indwelling placement in a patient's body. For example, the catheter element of a device of the invention can be dimensionally adapted for indwelling placement within the urethra and bladder of the patient, such that the balloon, when expanded, substantially fills the patient's bladder. The catheter element can include a drain opening near the distal end portion of the catheter, for draining urine
Bockelman Mark
Children's Medical Center Corporation
Engellenner Thomas J.
Nutter & McClennen & Fish LLP
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