Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
1999-01-11
2001-09-11
Bockelman, Mark (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S031000, C604S118000, C604S175000
Reexamination Certificate
active
06287275
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 and fluid refluxes that damage 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 are often quite successful at relieving the volumetric capacity deficiency of the body structure, the complications that arise from attaching different tissue types are often quite 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 arise due to the attachment of a tissue type that lacks sufficient compatibility with the natural tissue of the body structure.
Therefore, an object of the present invention is to provide systems and methods for providing a supply of tissue that is more compatible with the augmentation or reconstruction procedure.
SUMMARY OF THE INVENTION
The present invention provides systems and methods for promoting the growth of biological tissue for use in surgical procedures that augment the volumetric capacity of an natural body structure or for use in reconstructive surgery. The present invention provides methods for promoting progressive tissue growth for use as additional integument in reconstructive procedures. To this end, the present invention discloses system and methods that introduce a pressurized fluid within a body structure, or an interstice 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 generated tissue can then be excised and employed during surgical augmentation procedures to 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.
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, and will be further understood to include any surgically created interstice that defines an interior cavity surrounded by tissue.
In one aspect, the present invention encompasses devices for delivering fluids under pressure to an interstitial cavity within a patient. Generally, the devices include a catheter element that couples a source of fluid under pressure into fluid communication with the interstitial cavity, 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, and an attachment element that forms a pressure resistant seal that couples the interstitial cavity into fluid communication with the catheter element.
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 catheter element, and therefore, the fluid within the catheter, and that further includes a release plug that fluidity seals the release port to maintain fluid in the catheter 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 catheter, or in the interstitial cavity, reaching the threshold fluid pressure limit.
The catheter element is adapted for conveying fluid under pressure to the interstitial cavity. The catheter element can include a silastic catheter tube that has a portion dimensionally adapted to fit within an interstitial lumen, such as the ureter. Depending upon the application, the catheter can be short or long section of silastic tube or other polymeric tubing that extends from a subcutaneous injection port and has the valve element incorporated therein. The interstitial cavity being dilated can be brought proximate to the catheter and coupled thereto by the attachment element.
The catheter element can further include a pointed tubular element adapted for penetrating tissue surrounding an interstitial cavity. The pointed element can attach to the distal end of the catheter and can be formed of a rigid material, such as poly methyl methacrylate, for penetrating tough fibrous membrane. The attachment element can be integrated with the catheter and can include a notched exterior surface for engaging the tissue surrounding the interstitial cavity and/or a threaded exterior surface adapted for rotationally engaging the tissue surrounding an interstitial cavity.
In one embodiment of the present invention, the fluid delivery system includes a catheter element that is surgically attached to an interstitial cavity and maintained as an intracorporeal catheter within the patient. The catheter connects to a port element that can include an injection port that has an elastic septum adapted for maintaining a fluid under pressure within the catheter element. The port can connect to a pump element that provides a source of fluid a selected pressure.
In another embodiment, the present invention can be realized as a fluid delivery system that includes a pump element for providing a source of fluid under pressure, a catheter element for conveying the fluid to the interior of the cavity, an injection port element that fluidity couples the pump element with the catheter element and a valve element that restricts the direction of fluid flow thereby p
Bockelman Mark
Children's Medical Center Corporation
Engellenner Thomas J.
Nutter & McClennen & Fish LLP
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