Methods and products for reducing tissue trauma using water-absorbing stress-distributing materials

Abstract

Methods and products for protecting tissue of a patient during a surgical procedure that involve making an incision in the tissue and retracting the tissue to make a larger opening, wherein the methods and products use a water-absorbing stress-distributing layer.

What is claimed is: 
     
         1 . A method of protecting tissue of a patient during a surgical procedure, the method comprising:
 providing a water-absorbing stress-distributing layer comprising a hydrogel, a hydrocolloid, or a combination thereof; wherein the stress-distributing layer has opposite first and second major surfaces and at least a portion of the stress-distributing layer is greater than 2 mm thick between the first and second major surfaces;   adhering the stress-distributing layer to the patient such that it conforms to the shape of the tissue of the patient;   making an incision through the stress-distributing layer into the tissue; and   retracting the tissue along the incision using a retractor;   wherein the stress-distributing layer undergoes stretching and/or compression during retraction.   
     
     
         2 . The method of  claim 1  wherein at least one of the major surfaces of the stress-distributing layer is attached to a flexible polymeric film to form a stress-distributing composite, adhering the stress-distributing layer comprises adhering the stress-distributing composite to the patient such that the stress-distributing composite conforms to the shape of the tissue of the patient, and making an incision comprises making an incision through the stress-distributing composite into the tissue. 
     
     
         3 . The method of  claim 1  further comprising:
 providing a surgical incise drape comprising a flexible polymeric film having opposite first and second major surfaces, and a layer of a pressure sensitive adhesive disposed on at least a portion of one major surface; 
 adhering the surgical incise drape to the patient; and 
 attaching the stress-distributing layer to the incise drape; 
 wherein making an incision comprises making an incision through the stress-reducing material and the surgical incise drape into the tissue. 
 
     
     
         4 . The method of  claim 1  further comprising:
 providing a surgical incise drape comprising a flexible polymeric film having opposite first and second major surfaces, and a layer of a pressure sensitive adhesive disposed on at least a portion of one major surface; 
 adhering the stress-distributing layer to the patient; and 
 adhering the surgical incise drape to the stress-distributing layer; 
 wherein making an incision comprises making an incision through the stress-reducing material and the surgical incise drape into the tissue. 
 
     
     
         5 . A method of protecting tissue of a patient during a surgical procedure, the method comprising:
 providing a flexible polymeric film having opposite first and second major surfaces;   providing a water-absorbing stress-distributing layer comprising a hydrogel, a hydrocolloid, or a combination thereof; wherein the stress-distributing layer has opposite first and second major surfaces and at least a portion of the stress-distributing layer is at least 1 mm thick between the first and second major surfaces;   placing the flexible polymeric film and the stress-distributing layer in contact with one another so that the flexible polymeric film and the stress-distributing layer are attached together to form a stress-distributing composite, and the stress-distributing composite is adhered to the patient such that the stress-distributing composite conforms to the shape of the tissue of the patient;   making an incision through the stress-distributing composite into the tissue; and   retracting the tissue along the incision using a retractor;   wherein the stress-distributing composite undergoes stretching and/or compression during retraction.   
     
     
         6 . A method of protecting tissue of a patient during a surgical procedure, the method comprising:
 providing a surgical incise drape comprising a flexible polymeric film having opposite first and second major surfaces and a pressure sensitive adhesive on at least a portion of at least one major surface thereof;   providing a free-standing water-absorbing stress-distributing layer comprising a hydrogel, a hydrocolloid, or a combination thereof; wherein the stress-distributing layer has opposite first and second major surfaces;   adhering the surgical incise drape to the patient;   adhering the free-standing stress-distributing layer to the surgical incise drape;   making an incision through the incise drape and the stress-distributing layer into the tissue; and   retracting the tissue along the incision using a retractor;   wherein the surgical incise drape and stress-distributing layer undergo stretching and/or compression during retraction.   
     
     
         7 . The method of any one of the preceding claims wherein the water-absorbing stress-distributing layer comprises a hydrocolloid. 
     
     
         8 . The method of any one of the preceding claims wherein the water-absorbing stress-distributing layer is porous. 
     
     
         9 . The method of any one of the preceding claims wherein the tissue of the patient is initially treated with a presurgical skin preparation. 
     
     
         10 . The method of any one of the preceding claims wherein the tissue of the patient is initially treated with a barrier film. 
     
     
         11 . A method of protecting tissue of a patient during a surgical procedure, the method comprising:
 providing a presurgical skin preparation;   providing a free-standing water-absorbing stress-distributing layer comprising a hydrogel, a hydrocolloid, or a combination thereof, wherein the stress-distributing layer has opposite first and second major surfaces;   treating the patient's skin with a presurgical skin preparation;   adhering the free-standing water-absorbing stress-distributing layer to the patient over the area treated with the presurgical skin preparation;   making an incision through the presurgical skin preparation and the stress-distributing layer into the tissue; and   retracting the tissue along the incision using a retractor; wherein the presurgical skin preparation and stress-distributing layer undergo stretching and/or compression during retraction.   
     
     
         12 . The method of any one of the preceding claims wherein the retracting does not displace the stress-distributing layer from the patient along the incision while undergoing stretching and/or compression during retraction. 
     
     
         13 . The method of any one of the preceding claims wherein the surgical procedure is a minimally invasive surgical procedure. 
     
     
         14 . The method of any one of the preceding claims wherein the surgical procedure is an open surgical procedure. 
     
     
         15 . A kit for use during a surgical procedure to protect tissue of a patient, the kit comprising:
 a surgical incise drape comprising a flexible polymeric film having opposite first and second major surfaces, a pressure sensitive adhesive disposed on at least a portion of at least one major surface of the film, and a release liner disposed on the pressure sensitive adhesive;   a water-absorbing stress-distributing layer having opposite first and second major surfaces, and a release liner disposed on at least one of the surfaces; wherein the water-absorbing stress-distributing layer comprises a hydrogel, a hydrocolloid, or a combination thereof; and   sterile packaging enclosing the surgical incise drape and stress-distributing layer.   
     
     
         16 . A kit for use during a surgical procedure to protect tissue of a patient, the kit comprising:
 a water-absorbing stress-distributing layer having opposite first and second major surfaces, and a release liner disposed on at least one of the surfaces; wherein the water-absorbing stress-distributing layer comprises a hydrogel, a hydrocolloid, or a combination thereof;   a presurgical skin preparation; and   sterile packaging enclosing the stress-distributing layer and the presurgical skin preparation.   
     
     
         17 . A kit for use during a surgical procedure to protect tissue of a patient, the kit comprising:
 a flexible polymeric film having opposite first and second major surfaces, a pressure sensitive adhesive disposed on at least a portion of at least one major surface of the film, and a release liner disposed on the pressure sensitive adhesive;   a water-absorbing stress-distributing layer having opposite first and second major surfaces, and a release liner disposed on at least one of the surfaces; wherein the water-absorbing stress-distributing layer comprises a hydrogel, a hydrocolloid, or a combination thereof;   a presurgical skin preparation; and   sterile packaging enclosing the surgical incise drape and stress-distributing layer.   
     
     
         18 . A stress-distributing composite adhered to the skin of a patient, the stress-distributing composite comprising:
 a presurgical skin preparation on the skin of the patient; and   a water-absorbing stress-distributing layer having opposite first and second major surfaces; wherein the water-absorbing stress-distributing layer comprises a hydrogel, a hydrocolloid, or a combination thereof; wherein at least a portion of the stress-distributing layer is at least 1 mm thick between the first and second major surfaces;   wherein the water-absorbing stress-distributing layer is adhered to the presurgical skin preparation on the patient's skin.   
     
     
         19 . A stress-distributing composite adhered to the skin of a patient, the stress-absorbing composite comprising:
 a presurgical skin preparation on the skin of the patient;   a surgical incise drape comprising a flexible polymeric film having opposite first and second major surfaces, a pressure sensitive adhesive disposed on at least a portion of at least one major surface of the film; and   a water-absorbing stress-distributing layer having opposite first and second major surfaces; wherein the water-absorbing stress-distributing layer comprises a hydrogel, a hydrocolloid, or a combination thereof; wherein at least a portion of the stress-distributing layer is at least 1 mm thick between the first and second major surfaces;   wherein the surgical incise drape is adhered to the presurgical skin preparation on the patient's skin by the pressure sensitive adhesive and the water-absorbing stress-distributing layer is attached to the incise drape on the surface opposite the pressure sensitive adhesive.